ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001197729

Ethics application status

Approved

Date submitted

12/08/2022

Date registered

7/09/2022

Date last updated

20/02/2024

Date data sharing statement initially provided

7/09/2022

Date results information initially provided

20/02/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Intensive prehabilitation for people living with chronic spinal cord injury: a feasibility trial

Scientific title

Intensive prehabilitation for people living with chronic spinal cord injury: a feasibility trial

Secondary ID [1]

GUSIP02

Universal Trial Number (UTN)

Trial acronym

SIP Rehab Phase 2 (Spinal Injury Project, Rehab 2)

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 study is a feasibility trial using an uncontrolled pre-post design, which measures feasibility and performance before and after the intervention.
This trial aims to examine whether intensive prehabilitation therapy can be safely and effectively delivered to people living with chronic spinal cord injury in Australia and who have undertaken minimal rehabilitation in the last two years. The feasibility trial will also test whether intensive prehabilitation improves overall health, social outcomes and functional recovery for people living with chronic spinal cord injury. This feasibility trial is a necessary next 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 and is the next phase after GUSIP02.

On-site program will be 2 hours per day plus 30 min of functional electrical stimulation sessions, 5 days per week, for 16 weeks
• 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 intervention will take place at a specialised gym: "Making Strides" on the Gold Coast, Queensland.

Examples of exercises that will be prescribed as part of each component of the intervention are as follows:

• Standing/Weight bearing:
Participants will perform load bearing in various setups depending on their level of function including standing frames, bodyweight support supplied via a harness and overhead hoist and manual facilitation.
• Gait training can be completed both overground using a 20m track system, as well as on a treadmill.

• Upper limb strength:
Upper body strengthening: Functional resistance exercises will be prescribed in line with task-specific demands of various activities of daily living. Overhead tasks as well as push and transfer strength are the main focus of these exercises.
Push-specific strengthening: Horizontal push-specific strengthening exercises will be incorporated to increase wheelchair propulsion strength and endurance, as well as general completion of Activities of Daily Living (ADLs). Resisted movements that are similar to the motion of wheelchair propulsion will be used for specificity (e.g. hand cycle ergometer, adaptive ski ergometer facing away from machine & cable resisted push motion intervals, as well as flat bench press using progressive overload).
Transfer-specific strength: For transfer-specific strength, vertical pushing movements focusing on triceps and pectoral strengthening will be used, as well as scapular depression exercises.
• Trunk stability/ core strength:
Concentric and isometric core exercises will be prescribed to strengthen muscles involved in various functional movements/postures.
• Aerobic training:
Aerobic exercises may include arm cycle ergometry, seated ski ergometry, seated boxing (low impact), and seated rope work.

Functional Electrical Stimulation (FES):

Participants will complete either upper or lower body FES cycle ergometry or a combination of both with a total session capacity of 5 times per week. Pulse width is set at 250pw for all participants and frequency is set at 40Hz. Amplitude ranges from 1-140mA determined by preforming a muscle test on each of the muscle groups (quads, hamstrings and glutes).

The program will be personalised 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.

The exercise program will be tailored to the participant’s level of injury and neurological function/ ambulatory capacity at the discretion of the exercise physiologists and physiotherapists, with examples including reducing the weight and number of repetitions of training exercises or omitting activities/exercises that can’t be performed by the participant.

The total intervention time is 16 weeks 'on site' and then there is a follow up with participants at 2 weeks post intervention.

The program will be supervised/facilitated by an exercise physiologist.

Strategies used to monitor adherence to the intervention are as follows:
Participants will complete a Log of Activities every day and exercise
physiologists/physiotherapists will also capture participants’ compliance during the program.

The mode of delivery will be one-on-one. The cohort of participants at any one time will be a maximum of 5 participants, due to the capacity of the service provider Making Strides.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of delivering an intensive 16-week rehabilitation program in terms of recruitment rate. i.e.
willingness of participants to complete the prehabilitation program.

Method of Assessment: reporting the number of days needed to recruit five participants for the study.

Timepoint [1]

2 weeks after completion of the intervention

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]

2 weeks post intervention completion

Primary outcome [3]

Identication of barriers and enablers to implementation of the intervention. Method of assessment: x2 focus groups (face-to-face, groups of 5) assessed by qualitative thematic analysis with participants.

Timepoint [3]

x1 focus group 2 weeks prior to commencement of intervention
x1 focus group at 2 weeks post-intervention completion

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 (face-to-face, groups of 5) 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 and x1 focus group 2 weeks after conclusion of intervention

Secondary outcome [2]

*Additional Primary Outcome (5)*: Acceptability of the intensive 16-week prehabilitation
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 (2 weeks after the completion of the intervention. Daily 'logs of activities' will be recorded daily during the 16 week intervention period.

Secondary outcome [3]

*Additional Primary Outcome (6)*: Participant compliance: during intervention program. Method of assessment: daily logs of activities.

Timepoint [3]

*Additional Primary Timepoint (6)*: Participant compliance will be measured daily during the 16 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. It 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 further complicated 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. Like 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 + 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 is often 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.

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. Edemas in the lower extremities of the body such as the legs, ankles and feet are 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 because 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: Changes in vital signs (body temperature) using a digital thermometer.

Timepoint [5]

Secondary Timepoint 1: At screening 2 weeks prior to intervention, then week 1, week 9 and week 16 of intervention.

Secondary outcome [6]

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

Timepoint [6]

Secondary Timepoint 2: At screening 2 weeks prior to intervention, then week 1, week 9 and week 16 of intervention.

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 screening 2 weeks prior to intervention, then week 1, week 9 and week 16 of intervention.

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 screening 2 weeks prior to intervention, then week 1, week 9 and week 16 of intervention.

Secondary outcome [9]

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

Timepoint [9]

Secondary Timepoint 5: At screening 2 weeks prior to intervention, then week 1, week 9 and week 16 of intervention.

Secondary outcome [10]

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

Timepoint [10]

Secondary Timepoint 6: At screening 2 weeks prior to intervention, then week 1, week 9 and week 16 of intervention.

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: Two weeks prior to intervention during screening, and at week 16 of the intervention

Secondary outcome [12]

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

Timepoint [12]

Secondary Timepoint 8: Two weeks prior to intervention during screening, and at week 16 of the intervention

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: Week 1, Week 9 and Week 16 of intervention.

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, Week 9, Week 16 of intervention.

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, Week 9, Week 16 of intervention.

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: 2 weeks prior to intervention, and week 16 of intervention

Secondary outcome [17]

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

Timepoint [17]

Secondary Outcome 13: Week 1, week 9 and week 16 of intervention

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: 2 weeks prior to intervention, week 1, week 9 and week 16 of intervention, 2 weeks post intervention completion.

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: 2 weeks prior to intervention, week 1, week 9 and week 16 of intervention, 2 weeks post intervention completion.

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: 2 weeks prior to intervention, week 1, week 9 and week 16 of intervention, 2 weeks post intervention completion.

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: 2 weeks prior to intervention, week 1, week 9 and week 16 of intervention, 2 weeks post intervention completion.

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: 2 weeks prior to intervention, week 1, week 9 and week 16 of intervention, 2 weeks post intervention completion.

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: 2 weeks prior to intervention, week 1, week 9 and week 16 of intervention, 2 weeks post intervention completion.

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 2 weeks post intervention completion.

Secondary outcome [25]

Secondary Outcome 21: Changes in pain as assessed by the Brief Pain Inventory (BPI)

Timepoint [25]

Secondary Timepoint 21: At week 1, week 9 and week 16 of the intervention program.

Secondary outcome [26]

Secondary Outcome 22: Changes in functional independence as assessed by the Functional Independence Measure (FIM)

Timepoint [26]

Secondary Timepoint 22: At week 1 and week 16 of intervention 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 will be included if they:

1. Have sustained a traumatic spinal cord injury a minimum of 12 months prior to consent and have completed their primary rehabilitation;
2. Have stable neurological level and functional ability of more than 6 months in duration;
3. Are over 18 years and able to give informed consent;
4. Are ASIA A or B (as per the International Standards for Neurological Classification of spinal cord injury) (documented by an ISNCSCI/ASIA exam performed by a qualified practitioner within the last 6 months);
5. Are able and willing to attend an exercise program five times per week for 16 weeks;

7. Have not exercised more than 2 times a week, 40 weeks a year (or no more than 80 sessions per year), at a SCI recovery or specialist rehabilitation centre in the last two years;
8. Are considered by their general practitioner or specialist medical consultant to be fit to undertake the exercise program (documented approval by general practitioner required).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Participants will not be included if they:
1. Have significant concomitant central nervous system, peripheral nervous system or musculoskeletal system injuries or disorders limiting ability to exercise;
2. Have had recent major trauma or surgery within the last 6 months;
3. Have an existing stage 3 or 4 pressure ulcer according to the National Pressure Ulcer Advisory Panel classification;
4. Have endocrinopathy or metabolic disorders of the bone, such as Paget’s disease, lytic or renal bone disease, and senile osteoporosis;
5. Have a medical history of exposure to medication(s) known to affect mineral or bone metabolism;
6. Have significant impairment or disability, including physical, neurological or psychological impairments, additional to the spinal cord injury;
7. Have a history of long bone fracture incompletely healed;
8. Have extensive fixed contractures in the upper or lower limbs;
9. Have severe spasticity;
10. Have uncontrolled neuropathic pain;
11. Have autonomic dysreflexia without a management plan;
12. Are unable to complete the 2-week pre-intervention assessments and the 2-week follow-up assessments;
13. Have any contraindications to FES such as a cardiac pacemaker, epilepsy, lower limb fracture or pregnancy;
14. 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;
15. Have symptomatic, radiologically demonstrated, or provocatively demonstrated ischaemic heart disease;
16. Have current thromboembolic disease;
17. Are using illicit drugs;
18. 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;
19. Are unable to tolerate the 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 prehabilitation 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.

Information about feasibility, acceptability and safety will be reported at multiple timepoints (week 9, at end of on-site training at week 16, and at 2-weeks post-intervention).

Changes over the study period will be reported for all secondary outcome measures. Descriptive statistics will be presented at different timepoints (where available): 2-weeks pre-intervention, weeks 1, 9 and 16 of the on-site program, and 2 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 the program for the associated measures.

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.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/09/2022

Actual

30/01/2023

Date of last participant enrolment

Anticipated

30/09/2022

Actual

21/02/2023

Date of last data collection

Anticipated

3/03/2023

Actual

7/07/2023

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]

None

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]

09/08/2022

Approval date [1]

19/10/2022

Ethics approval number [1]

Summary

Brief summary

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 and is aimed at people with spinal cord injury that have undertaken minimal rehabilitation in the last two years.

Step 5: Key Inclusion Criteria point 6 (omitted from original list): 6. Are vaccinated against COVID-19 and have had their COVID-19 booster (if eligible);

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

+61756780303

[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, Parklands Drive, Griffith University, Southport, 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, Parklands Drive, Griffith University, Southport, 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
16903	Study protocol	[email protected]
16904	Statistical analysis plan	[email protected]
16905	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