ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000679886

Ethics application status

Approved

Date submitted

23/03/2021

Date registered

3/06/2021

Date last updated

22/11/2022

Date data sharing statement initially provided

3/06/2021

Date results information initially provided

18/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Intensive long-term rehabilitation for people living
with chronic spinal cord injury: a feasibility trial

Scientific title

Intensive long-term rehabilitation for people living
with chronic spinal cord injury: a feasibility trial

Secondary ID [1]

GUSIP01

Universal Trial Number (UTN)

Trial acronym

SIP Rehab (Spinal Injury Project, Rehab)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Spinal Cord Injury

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The SIP Rehab study is a feasibility trial using an uncontrolled pre-post design,
which measures feasibility and performance before and after the
intensive long-term rehabilitation intervention.
This trial aims to examine whether long-term intensive rehabilitation
therapy can be safely and effectively delivered to people living with
chronic spinal cord injury in Australia. The feasibility trial will also
test whether long-term intensive rehabilitation improves overall
health, social outcomes and functional recovery for people living
with chronic spinal cord injury. This feasibility trial is a necessary
first step toward the anticipated full cell transplantation –
rehabilitation clinical trial that the Clem Jones Centre for
Neurobiology and Stem Cell Research at Griffith University is
working towards.

The ‘on-site’ program (16 weeks) used in the trial will include: 2 hours per day on site, 5 days per week, with an additional 5x 30 minutes of functional electrical stimulation sessions. The location for the ‘on-site’ portion of the intervention is at a specialised gym: “Making Strides” on the Gold Coast, Queensland.
The total weekly ‘on-site’ activities will consist of:
• Standing: 150 min per week (30 min per day, 5 days per week)
• Gait training: 90 min per week (30 min per day, 3 days per week)
• Upper limb strength: 150 min per week (30 min per day, 5 days per week)
• Trunk stability/core strength: 90 min per week (30 min per day, 3 days per week)
• Aerobic training: 120 min per week (30 min per day, 4 days per week)
• Functional electrical stimulation (FES): 150 min per week (30 min per day, 5 days per
week)

The ‘at-home’ program (10 weeks), will include a personalised program involving the following exercises:
• Unilateral humeral abduction
• Unilateral humeral flexion
• Unilateral dumbbell shoulder press
• Bilateral dumbbell chest press
• Dumbbell assisted sit-up
• Short sitting unilateral band row
• Plank
• Palof press
• Dumbbell assisted back extension performed in wheelchair.

Each exercise is to be performed at weights prescribed by the
Exercise Physiologist. Each exercise is to be performed for 3 sets of 15 reps.
The programs, including intensity levels for each participant, will be personalised by qualified exercise physiologists at the service provider (Making Strides) to suit each individual’s
injury as it is difficult to have a standardised program due to the
varied nature of SCI, the variance in function, and the exercise
capacity.

For the ‘on site’ portion of the trial, materials will include: bodyweight support supplied via harness and overhead hoist, rubber resistance bands, 20m track system, squat rack with fixed arm supports, forearm support walking frames, crutches, hand cycle ergometer, adaptive ski ergometer, cable machines, arm cycle ergometry, seated ski ergometry, ropes, functional electrical stimulation, and weights. The ‘at home’ portion of the trial will use weights and rubber resistance bands (supplied).

The 'at home' program will be
personalised as it is difficult to have a standardised program due to the nature of SCI, the variance
in function, and the exercise capacity.
For participant safety and reproducibility, as well as to minimise assistance and equipment needs,
the exercises listed below will be prescribed to each participant to be performed 5 days each week. Each exercise is to be performed for 3 sets of 15 reps.

The mode of delivery will be face-to-face for the ‘on-site’ portion of the trial, and the ‘at-home’ program will be prescribed by the exercise physiologist and will be performed at home, or at a local gym, with weekly 30-minute virtual check ins with exercise physiologists.

The 'on-site' program will be completed before the 'at-home' program and the 'at-home' program will begin after the 'on-site' program has been completed. i.e. the programs will be run sequentially. The order of the programs is the same for all participants.

Intervention adherence or fidelity will be assessed through the use of a log of activity, recorded by the participant during the whole program, and by the staff at Making Strides during the on-site program. Adherence and Fidelity will be analysed by an independent statistical team. Strategies to maintain or improve fidelity, will be via support of Making Strides staff to motivate and maintain fidelity of participation. For the ‘at-home’ program, Making Strides staff will perform a weekly virtual call with the participant.

The total intervention time is 26 weeks (16 weeks 'on site' and 10 weeks 'at home') then there is a follow up with participants at 2 weeks post intervention and 8 weeks post intervention.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of delivering an intensive 26-week rehabilitation program in terms of recruitment rate. i.e. willingness of participants to complete the rehabilitation program. Method of Assessment: counting the number of people who are successfully recruited for the trial by audit of the study database assembled for the trial.

Timepoint [1]

8 weeks after the completion of the 'at home' program.

Primary outcome [2]

Feasibility of collecting outcome assessment data. Method of assessment: count the total number of completed surveys and assessments during the trial, compared to what was assigned to be completed.

Timepoint [2]

Measured at 8 weeks post conclusion of ‘at home’ program

Primary outcome [3]

Identification of barriers and enablers to implementation of the intervention. Method of assessment: x2 focus groups assessed by qualitative thematic analysis with participants.

Timepoint [3]

x1 focus group 2 weeks prior to commencement of intervention (i.e. 2 weeks prior to start of 'on site' program

x1 focus group 8 weeks after conclusion of intervention (i.e. 8 weeks after the conclusion of the 'at home' program.

Secondary outcome [1]

*Additional Primary Outcome (4)*: Intervention fidelity of the service provider Making Strides to identify barriers to performing the protocol from their perspective, i.e., what is working, what is not working, what is feasible. Method of assessment: x2 focus groups assessed by qualitative thematic analysis with Making Strides staff. Also, analysis of 'logs of activities'.

Timepoint [1]

*Additional Primary Timepoint (4)*: x1 focus group 2 weeks prior to commencement of intervention (i.e. 2 weeks prior to start of 'on site' program

x1 focus group 8 weeks after conclusion of intervention (i.e. 8 weeks after the conclusion of the 'at home' program.

Secondary outcome [2]

*Additional Primary Outcome (5)*: Acceptability of the intensive 26-week rehabilitation program as assessed by: Retention rate. Method of assessment: Retention rate corresponds to the total number of participants who stayed for the whole program divided by the total number of participants recruited for the program and multiplied by 100. Also analysis of daily 'logs of activities'.

Timepoint [2]

*Additional Primary Timepoint (5)*: retention rate measured at the end of the program (8 weeks after the completion of the 'at home' program. Daily 'logs of activities' will be recorded daily during the 26 week intervention period.

Secondary outcome [3]

*Additional Primary Outcome (6)*: Participant compliance: during ‘on-site’ and ‘at home’ programs. Method of assessment: daily logs of activities.

Timepoint [3]

*Additional Primary Timepoint (6)*: Participant compliance will be measured daily during the 26 week intervention period.

Secondary outcome [4]

*Additional Primary Outcome (7)*: Assessment of the safety of the program. Method of assessment: the incidence of adverse events. Adverse events for this study will be assessed using the following categories:
• Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities.
• Moderate: An event that causes sufficient discomfort to interfere with normal everyday activities.
• Severe: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilised for rating the intensity of an event; and both AEs and SAEs can be assessed as severe.

Adverse events as listed below will be assessed in accordance with and as per the protocol.

Examples of known/possible adverse reactions/events and how assessed:

Autonomic dysreflexia (AD)
AD is defined as episodic hypertension and concomitant baroreflex-mediated bradycardia initiated by unmodulated sympathetic reflexes in the decentralised spinal cord. AD can be caused by a plethora of stimuli from a noxious stimulus to catheter/ bowel issues. Potentially life-threatening hypertension can occur if stimulus is not identified/ managed appropriately. Participants with any risk of AD or history of should carry a glyceryl trinitrate (GTN) spray. Typically, only seen in participants at T6 and above. AD can also cause headaches and reddening of the skin on the upper chest (erythema) and could cause cerebral haemorrhage. Other symptoms of AD can include sweating, nausea, goosebumps below the level of injury and nasal stuffiness.

Skin breakdown
Any shear friction on any part of the skin can cause skin breakdown. Typical areas of concern are elbows and forearms, hands and ischial tuberosities. This risk is complicated further with decreased sensory function. Usually, the lower limbs are of greater concern as blood flow and fluid exchange is decreased and therefore healing timeframes are much slower and there is risk for progression requiring bed rest, thus skin breakdown can be very debilitating. Skin breakdown is one of the highest causes of hospital readmission post spinal cord injury. Skin reactions can also occur during Functional Electrical Stimulation from the attachment of electrodes. However, skin breakdown is unlikely to occur at the intensity used in this study. As the participants are seen regularly, the practitioners would be able to identify a cumulative effect of the electrodes if frequency was the cause, and act accordingly before skin breakdown.

Pressure ulcers due to equipment used during the exercise e.g., harness placement
Pressure ulcer formation due to equipment use is possible, however not prevalent. Harnesses have appropriate padding, and additional support in trouble areas specific to participants can be provided. Similar to skin breakdown - the frequency of visits of the participant in the trial will result in frequent assessment and participant reports of increasing redness in prone areas would be reported.

Soft tissue injury
Due to limited working musculature and upper limb mobility tasks causing frequent repetition of similar movement patterns, overuse injuries of the shoulder, elbow and wrist are common in this population. Further demand on working muscle groups during the study could exacerbate this. Strain / full rupture is also a risk of any exercise, particularly when accurate pain response is absent or impaired as in this population.

Upper extremity and shoulder pain
Shoulder pain and upper extremity pain is common after SCI. This pain can develop due to intensive upper-body activities including wheelchair propulsion, transfers, reaching overhead and tasks requiring strong force through the hand. Injured rotator cuff tendons are common in SCI patients with shoulder pain. Upper extremity and shoulder pain is covered by the section ‘soft tissue injury’.

Joint swelling and ankle/knee/elbow pain
Swelling of the joints would be an inflammatory response associated with soft or hard tissue injury (see above). Swelling of joints and painful joints could also be associated with exacerbation of arthritis. If a participant had significant chronic joint pain identified in pre-screening, it would be advised that an x-ray be performed for diagnosis of arthritis for prescription consideration.

Fracture
Decreased BMD leading to osteopenia/osteoporosis is prevalent in the SCI population. Any weight bearing task carries a degree of risk that is mitigated as well as possible with appropriate equipment and supports relative to the person’s presentation.

Postural or orthostatic hypotension
People with a SCI level above T6 have an increased risk of orthostatic hypotension occurring during postural changes such as supine to sitting and sitting to standing. Common symptoms include light-headedness, dizziness, and nausea. If not managed appropriately, it can lead to loss of consciousness which is obviously dangerous if in an unsupported or especially weight-bearing position. Post exercise hypotension is also an increased risk, therefore possibly look to ensure a 15 min time post session before allowing participants to drive. One symptom of orthostatic hypotension is ringing in the ears with dizziness, and or fainting.

Dizziness and/or nausea
This is usually attributed to orthostatic hypotension but can be due to over-exertion. Instances of nausea are less prevalent compared to dizziness.

Falls
Falls are a rarity in practice by the service provider. In any case of a participant performing weight-bearing or walking in an exercise, an exercise physiologist should be in a close spotting position to prevent a full fall that could result in injury.

Headache
As mentioned above, headache can be a symptom of autonomic dysreflexia. Another cause could be ‘primary exercise headache’ brought on by strenuous exercise, however this is uncommon and often is hard to attribute to exercise as a cause.

Overheating/hyperthermia
Due to inability to sweat below the neurological level of injury, thermoregulation is an issue for this population and if not monitored can lead to adverse reactions/symptoms.

Bladder/ bowel accidents
Due to slowed bowel and bladder motility and potential spastic muscles in the gastro/urinary tracts, exercise can sometimes cause spasm or increase peristalsis and lead to involuntary bowel or bladder accidents during exercise.
This risk is increased when participants are in an upright/standing position which decreases compression of the gastrointestinal tract and greater freedom for matter to move through. Therefore, standing/ dynamic movement during exercise may lead to bowel accidents.

Bladder dysfunction (incl. UTI).
SCI can change the way a bladder works, and it may empty too frequently, or not empty enough. Neurogenic urinary tract dysfunction is common among individuals with SCI and may lead to common complications such as renal insufficiency (poor function of the kidneys), incontinence, and urinary tract infections (UTIs). Catheterisation of SCI patients can result in an increase in UTIs. It is highly unlikely that exercise will contribute to UTI and exercise is usually associated with lower incidence in the literature. One way it could occur in a session is through a bare Suprapubic Catheter (SPC) site on a non-sterile site, however a direct relationship between the two would be hard to identify. One other possibility is a misplaced harness causes irritation to an already irritated SPC site.

Increased spasticity
Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness of muscle, which might interfere with movement, speech, or be associated with discomfort or pain. Spasticity is common when starting a new program which can hinder sleep, decrease transfer ability and general comfortability.

General fatigue and Delayed Onset Muscle Soreness (DOMS)
Fatigue is defined as the inability of muscles to maintain the required level of strength during exercise. It can also be a term used to describe a decrease in physical performance associated with an increase in the real/perceived difficulty of a task or exercise. For a person with SCI this could be evident in loss of strength in upper limbs. Fatigue could also be evident in participants who have an inability to keep up with the speed or intensity of the exercise being undertaken.

Delayed Onset Muscle Soreness is exercise-related muscle pain that can develop after excessive exercise, returning to exercise after a period of reduced activity and when performing new or unaccustomed exercises. DOMS can be particularly prevalent if the exercise has an eccentric (tension being applied to a muscle as it lengthens) component. Symptoms can range from muscle tenderness or stiffness to severe debilitating pain. DOMS can be treated initially with active rest and anti-inflammatory measures such as ice.
DOMS is common for participants of any exercise regime and is therefore highly likely to occur for participants during the study.

Musculoskeletal pain
Pain is a common consequence following SCI with frequent occurrences of musculoskeletal and neuropathic pain. Musculoskeletal pain can be related to movement and can be acute (with rapid onset) intermittent, or chronic/constant. This pain can affect bones, muscles, ligaments, tendons, and nerves. Musculoskeletal pain can be localised in one area, or widespread. There is always an origin of pain due to acute tissue injury, chronic overuse injury, or neuropathic pain. Someone presenting with all three would be described as unlikely during the study.

Cardiovascular complications
The most important cardiovascular complications in the chronic phase of spinal cord injury are orthostatic hypotension (mentioned above) and impaired regulation of blood pressure/blood volume/blood temperature (mentioned above). Cardiovascular complications can accompany autonomic dysreflexia where the condition can result in a rise in blood pressure (BP). Outside of AD, large changes in BP are not common. AD can also cause headaches and reddening of the skin on the upper chest (erythema). Acute SCI patients can have cardiovascular complications that can include bradyarrhythmia, hypotension, increased vasovagal reflexes, supraventricular/ventricular ectopic beats, vasodilation, and venous stasis. Tetraplegia is usually associated with lower cardiac output and minimal increases in blood pressure. For individuals with hypertension as a comorbidity, some forms of resistance exercise maybe limited, however aerobic exercise generally has positive acute and chronic hypotensive effects.

Thrombosis
SCI patients are predisposed to thromboembolism (blood clot formation) due to venous stasis (congestion and slowing of circulation in veins) and hypercoagulopathy (increased tendency to form blood clots). However, this is an extremely rare occurrence in the service provider’s experience outside of a pre-existing condition.

Edema
Edema is swelling caused by an accumulation of fluid in your body’s tissues. Edema in the lower extremities of the body such as the legs, ankles and feet is a common problem for SCI patients since paralysed muscles are unable to pump blood that has pooled in the legs due to gravity, back from veins in the legs to the heart. The blood then collects in the lower extremities, and fluid from the blood leaks out of the vessels into the surrounding tissue. A patient’s edema can increase throughout the day and the service provider recommends participants to wear compression or circulation stockings. Exercise usually has a positive effect on edema.

Respiratory problems and chest infections
Patients with SCI can have profound respiratory problems related to the level of injury and loss of motor, sensory and autonomic control. Low lung volumes and a weak cough as a result of weakness to the respiratory muscle is more severe in higher cervical injuries. Respiration and perceived exertion during exercise sessions is monitored closely by the service provider. If a participant has a co-morbidity of any respiratory condition, the service provider will monitor oxygen saturation via pulse oximeter during a session of exercise. It is unknown whether exercise can contribute to chest infections, however active individuals tend to have lower incidences of chest infection as exercise helps to loosen mucus and prevent build-ups associated with infections.

Mental Problems
Adult SCI patients have a higher risk of developing mental health disorders, including depression and anxiety, compared to adults without SCI. However, exercise intervention and resultant increase in independence can have a positive effect on mental health problems. The service provider reports that there can be cases of people who have increased mental health symptoms throughout their exercise program due to unrealistic expectations not being met. Therefore, prognosis on neurological outcomes is not offered by the service provider.

Timepoint [4]

*Additional Primary Timepoint (7)*: AE recorded daily for the duration of the program.

Secondary outcome [5]

Secondary Outcome 1: Changes in physiology: vital signs: body temperature. Method of assessment: thermometer

Timepoint [5]

Secondary Timepoint 1: At baseline then week 1, week 9 and week 16 of ‘on site program’ and then week 10 of ‘at home’ program.

Secondary outcome [6]

Secondary Outcome 2. Changes in physiology: vital signs: blood pressure: Method of assessment: sphygmomanometer

Timepoint [6]

Secondary Timepoint 2: At baseline then week 1, week 9 and week 16 of ‘on site program’ and then week 10 of ‘at home’ program.

Secondary outcome [7]

Secondary Outcome 3: Changes in physiology: vital signs: heart rate: Method of assessment: Heart rate monitor

Timepoint [7]

Secondary Timepoint 3: At baseline then week 1, week 9 and week 16 of ‘on site program’ and then week 10 of ‘at home’ program.

Secondary outcome [8]

Secondary Outcome 4: Changes in physiology: vital signs: respiration rate: Method of assessment: Involves counting the number of breaths for one minute by counting how many times the chest rises.

Timepoint [8]

Secondary Timepoint 4: At baseline then week 1, week 9 and week 16 of ‘on site program’ and then week 10 of ‘at home’ program.

Secondary outcome [9]

Secondary Outcome 5: Changes in physiology: vital signs: oxygen saturation. Method of assessment: pulse oximeter

Timepoint [9]

Secondary Timepoint 5: At baseline then week 1, week 9 and week 16 of ‘on site program’ and then week 10 of ‘at home’ program.

Secondary outcome [10]

Secondary Outcome 6: Changes in physiology: spirometry. Method of assessment: spirometer

Timepoint [10]

Secondary Timepoint 6: At baseline then week 1, week 9 and week 16 of ‘on site program’ and then week 10 of ‘at home’ program.

Secondary outcome [11]

Secondary Outcome 7: Changes in physiology: bone mineral density. Method of assessment: , bone mineral density assessed using a DXA scan

Timepoint [11]

Secondary Timepoint 7: At baseline and at week 16 of 'on-site' training program and week 10 of 'at-home' program.

Secondary outcome [12]

Secondary Outcome 8: Haematology, biochemistry and lipid profile: Method of assessment: pathology blood tests

Timepoint [12]

Secondary Timepoint 8: At baseline and at week 16 of ‘on site program’ and at week 10 of ‘at home’ program

Secondary outcome [13]

Secondary Outcome 9: Cardiovascular function: Method of assessment: as measured by 6 minute graded arm cycle ergometry

Timepoint [13]

Secondary Timepoint 9: Assessed at week 1, 9, and 16 of 'on-site' program and week 10 of 'at-home' program.

Secondary outcome [14]

Secondary Outcome 10: Motor Function: Method of assessment: as assessed by the motor testing
evaluation, which includes manual muscle testing, motor
development scale, 6-minute walk/push test, and modified functional reach test

Timepoint [14]

Secondary Timepoint 10: (week 1, 9, and 16 of 'on-site' program and week 10 of 'at-home' program.)

Secondary outcome [15]

Secondary Outcome 11: Strength: Method of assessment: assessed by the 5-Repetition Maximum Strength test.

Timepoint [15]

Secondary Timepoint 11: (week 1, 9, and 16 of 'on-site' program and week 10 of 'at-home' program.)

Secondary outcome [16]

Secondary Outcome 12: changes in sensory function: Method of assessment: as assessed by the International Standards for neurological classification of spinal cord injury (ISNCSCI) also known commonly as the ASIA impairment scale

Timepoint [16]

Secondary Timepoint 12: At baseline and at week 10 of ‘at home’ program.

Secondary outcome [17]

Secondary Outcome 13: changes in fatigue as assessed by the Fatigue severity scale (FSS)

Timepoint [17]

Secondary Timepoint 13: Assessed at week 1, 9 and 16 of on-site program, week 10 of 'at-home' program

Secondary outcome [18]

Secondary Outcome 14: changes in Depression as assessed by the Depression, anxiety, and stress scale – 21 item (DASS-21)

Timepoint [18]

Secondary Timepoint 14: Assessed at baseline and at weeks 1, 9, and 16 of on-site program, week 10 of 'at-home' program, 2 weeks post intervention, (i.e. 2 weeks after the completion of the ‘at home’ program), and 8 weeks post intervention (i.e. 8 weeks after completion of the ‘at home’ program)

Secondary outcome [19]

Secondary Outcome 15: changes in anxiety as assessed by the Depression, anxiety, and stress scale – 21 item (DASS-21)

Timepoint [19]

Secondary Timepoint 15: Assessed at baseline and at weeks 1, 9, and 16 of on-site program, week 10 of 'at-home' program, 2 weeks post intervention, (i.e. 2 weeks after the completion of the ‘at home’ program), and 8 weeks post intervention (i.e. 8 weeks after completion of the ‘at home’ program)

Secondary outcome [20]

Secondary Outcome 16: changes in stress as assessed by the Depression, anxiety, and stress scale – 21 item (DASS-21)

Timepoint [20]

Secondary Timepoint 16: Assessed at baseline and at weeks 1, 9, and 16 of on-site program, week 10 of 'at-home' program, 2 weeks post intervention, (i.e. 2 weeks after the completion of the ‘at home’ program), and 8 weeks post intervention (i.e. 8 weeks after completion of the ‘at home’ program)

Secondary outcome [21]

Secondary Outcome 17: changes in quality of life as assessed by the Assessment of quality of life-8D (AQoL-8D) instrument.

Timepoint [21]

Secondary Timepoint 17: at baseline and at weeks 1, 9, and 16 of on-site program, week 10 of 'at-home' program, 2 weeks post intervention (i.e. 2 weeks after the completion of the ‘at home’ program), and 8 weeks post intervention (i.e. 8 weeks after completion of the ‘at home’ program

Secondary outcome [22]

Secondary Outcome 18: changes in a measure of a person's perceived ability to cope effectively with life challenges assessed by the coping self-efficacy scale (CSE).

Timepoint [22]

Secondary Timepoint 18: at baseline and at weeks 1, 9, and 16 of on-site program, week 10 of 'at-home' program, 2 weeks post intervention (i.e. 2 weeks after the completion of the ‘at home’ program), and 8 weeks post intervention (i.e. 8 weeks after completion of the ‘at home’ program

Secondary outcome [23]

Secondary Outcome 19: changes adaptive skills for people with sensory or physical impairments as assessed by the Adaptive Behaviour Assessment System – Third Edition (ABAS-3).

Timepoint [23]

Secondary Timepoint 19: at baseline and at weeks 1, 9, and 16 of on-site program, week 10 of 'at-home' program, 2 weeks post intervention (i.e. 2 weeks after the completion of the ‘at home’ program), and 8 weeks post intervention (i.e. 8 weeks after completion of the ‘at home’ program

Secondary outcome [24]

Secondary Outcome 20: changes in daily mood as assessed by the Daily Mood rating form

Timepoint [24]

Secondary Timepoint 20: daily from 2 weeks prior to rehabilitation intervention to 8 weeks post intervention (i.e. 8 weeks after completion of the ‘at home’ program.)

Eligibility

Key inclusion criteria

Inclusion/exclusion criteria for participants have been determined in consultation with medical and
rehabilitation specialists including a clinician with a lived experience of SCI.

Participants are eligible to be included in the study only if all the following criteria apply:
i. Have sustained a traumatic spinal cord injury a minimum of 12 months prior to consent
and have completed their primary rehabilitation;
ii. Have stable neurological level and functional ability of more than 6 months in duration;
iii. Are over 18 years and able to give informed consent;
iv. Are ASIA A or B (as per the International Standards for Neurological Classification of
SCI);
v. Are able and willing to attend an exercise program five times per week for 26 (16 weeks 'on-site' and 10 weeks 'at-home') weeks;
vi. Are considered by their general practitioner or specialist medical consultant to be fit to
undertake the exercise program (documented approval by general practitioner or
specialist medical consultant required).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Participants are excluded from the study if any of the following criteria apply:
i. Have significant concomitant central nervous system, peripheral nervous system or
musculoskeletal system injuries or disorders limiting ability to exercise;
ii. Have had recent major trauma or surgery within the last 6 months;
iii. Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer
Advisory Panel classification;
iv. Have endocrinopathy or metabolic disorders of the bone, such as Paget’s disease, lytic
or renal bone disease, and senile osteoporosis;
v. Have a medical history of exposure to medication(s) known to affect mineral or bone
metabolism;
vi. Have significant impairment or disability, including physical, neurological or
psychological impairments, additional to the spinal cord injury;
vii. Have a history of long bone fracture incompletely healed;
viii. Have extensive fixed contractures in the upper or lower limbs;
ix. Have severe spasticity;
x. Have uncontrolled neuropathic pain;
xi. Have autonomic dysreflexia without a management plan;
xii. Are unable to attend the 2-week pre-assessment and the 8-week follow-up
assessments;
xiii. Have any contraindications to FES such as a cardiac pacemaker, epilepsy, lower limb
fracture or pregnancy;
xiv. Have any other serious medical condition including malignancies, psychiatric,
behavioral or drug dependency problems, which are likely to influence the
participant’s ability to cooperate or in the opinion of the study investigator would
prevent adherence to the protocol;
xv. Have symptomatic, radiologically demonstrated, or provocatively demonstrated
ischaemic heart disease;
xvi. Have current thromboembolic disease;
xvii. Are using illicit drugs;
xviii. Are participating in other clinical trials (including medication, therapeutic
interventions and alternative therapies) or taking medications (including herbal
preparations) that are not considered to be standard care as per the protocol;
xix. Are unable to tolerate expected exercise load.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The number of participants chosen was based upon the capacity of the service provider to take a certain number of participants for 2 hours a day, 5 days a week, for 16 weeks.

The study is a feasibility, acceptability, and safety study of an intensive long-term rehabilitation
program for people living with spinal cord injury.
There are no hypotheses tested regarding the amount of change in vital signs, motor function,
strength, cardiovascular function, sensory function, and psychosocial health that will potentially
be observed due to the nature of the study and the limited sample size.

For the purposes of analysis, the following analysis sets are defined:

Full analysis set: All participants who are enrolled in the study will be included in the
analyses.
Safety analysis set All participants who are exposed to the study intervention will be
included in the analyses.

Demographic information about the participants enrolled in the study including but not limited to
age, gender, level of injury, will be reported using median, inter-quartile range and range for
continuous data and frequency and percentage for categorical data.

Primary Endpoint(s)/Estimand(s) Analysis:
Feasibility of the rehabilitation program will be assessed by reporting the number of days needed
to recruit five participants for the study.
Acceptability of the program will be assessed by calculating retention rate and participant
compliance at different timepoints (at the end of the on-site program (week 16), at the end of the
at-home program, 2 weeks post intervention and 8 weeks post intervention). Overall retention rate
corresponds to the total number of participants who stayed for the whole program divided by the
total number of participants recruited for the program and multiplied by 100
The incidence of adverse events will be calculated to assess the safety of the program.
Information about feasibility, acceptability and safety will be reported at multiple timepoints (at 9
weeks, at end of on-site training, at end of at-home training (week 10 of at-home program), at 2
weeks post intervention and at 8 weeks post intervention).

Secondary Endpoint(s) Analysis

Changes over the study period will be reported for vital signs, BMD, spirometry, haematology,
biochemistry and lipid profile, motor function, strength, cardiovascular function, sensory function
and psychosocial health. Descriptive statistics will be presented at different timepoints (where
available): 2-weeks pre intervention, at 9 weeks, at end of on-site training, at end of at-home
training, at 2 weeks post intervention and at 8 weeks post intervention, using median, inter-quartile
range, and range for continuous data. Frequencies and percentages will be presented for categorical
data.

The change scores between baseline and each timepoint as well as percentage change scores
(calculated as the difference between timepoints and divided by baseline value and multiplied by
100) will be calculated and reported using descriptive statistics. The change scores will also be
dichotomised to evaluate how many participants increased, decreased or stayed stable during from
start to end of the program for the associated measures described above.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/07/2021

Actual

23/09/2021

Date of last participant enrolment

Anticipated

31/07/2021

Actual

23/09/2021

Date of last data collection

Anticipated

8/04/2022

Actual

17/06/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment hospital [1]

Gold Coast University Hospital - Southport

Recruitment postcode(s) [1]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Perry Cross Spinal Research Foundation

Address [1]

Level 7, 50 Cavill Avenue,
Surfers Paradise, QLD, 4217

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

170 Kessels Road,
Nathan, 4111,
Queensland

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Hospital and Health Service HREC

Ethics committee address [1]

Office for Research Governance and Development
Level 2 Block E – Pathology and Education
1 Hospital Boulevard
Southport, QLD, 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/03/2021

Approval date [1]

29/04/2021

Ethics approval number [1]

HREC/2021/QGC/74249

Ethics committee name [2]

GRIFFITH UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE

Ethics committee address [2]

Research Ethics & Integrity Office for Research Griffith University, Nathan, QLD, 4111.
Level 0, Bray Centre

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

21/05/2021

Approval date [2]

27/05/2021

Ethics approval number [2]

2021/374

Summary

Brief summary

This study will measure whether an intensive, long-term rehabilitation program can be delivered safely and effectively to people living with chronic spinal cord injury in Australia. It will also measure whether long-term intensive rehabilitation improves overall
health, social outcomes and functional recovery for people living
with chronic spinal cord injury.

Trial website

Trial related presentations / publications

Public notes

The program will be personalised to suit each individual's injury e.g. weight, number of repetitions.

Contacts

Principal investigator

Name

Dr Dinesh Palipana

Address

Principal House Officer (Emergency Department)
Gold Coast University Hospital
1 Hospital Blvd, Southport, QLD, 4215

Country

Australia

Phone

+61756780704

Fax

+61 7 5678 0303

[email protected]

Contact person for public queries

Name

Dr Andrew Rayfield

Address

Menzies Health Institute Queensland,
Ian O’Connor Building (G40),
Room 9.08 Gold Coast campus, Griffith University,
QLD 4222

Country

Australia

Phone

+61756780917

Fax

[email protected]

Contact person for scientific queries

Name

Dr Andrew Rayfield

Address

Menzies Health Institute Queensland,
Ian O’Connor Building (G40),
Room 9.08 Gold Coast campus, Griffith University,
QLD 4222

Country

Australia

Phone

+61756780917

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data that underlie published results, after deidentification (text, tables, figures, and appendices).

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years following article publication

Available to whom?

Researchers who provide a methodologically sound proposal.

Available for what types of analyses?

To achieve aims in the approved proposal.

How or where can data be obtained?

Proposals should be directed to [email protected] . To gain access, data requestors will need to sign a data access agreement.

What supporting documents are/will be available?

Doc. No.	Type	Email
11141	Study protocol	[email protected]
11142	Statistical analysis plan	[email protected]
11143	Analytic code	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically