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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01236976




Registration number
NCT01236976
Ethics application status
Date submitted
8/11/2010
Date registered
9/11/2010
Date last updated
3/05/2021

Titles & IDs
Public title
SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
Scientific title
SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury
Secondary ID [1] 0 0
SCIPA Full-On
Universal Trial Number (UTN)
Trial acronym
SCIPAFull-On
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Therastride Treadmill System
Treatment: Devices - FES-assisted cycling
Other interventions - Trunk and upper and lower limb exercises
Other interventions - Upper body strength and fitness program

Experimental: Intervention Group - Participants in Group A will receive a triad of interventions comprising body weight supported treadmill training (BWSTT) using the Therastride Treadmill System, functional electrical stimulation (FES)-assisted cycling, and trunk and upper and lower limb exercise. These interventions will be provided at the spinal unit.

Other: Control Group - Participants in Group B will receive an upper body strength and fitness program. This program may be provided at the spinal unit, or an appropriately equipped gymnasium as approved by the SCIPA Full-On Project Committee. It will be based on the Burn Rubber Burn (BRB) exercise program already established in Sydney. BRB is a circuit-based exercise program incorporating resistance and cardiovascular training. For this protocol, the circuit will comprise several stations using different pieces of equipment.


Treatment: Devices: Therastride Treadmill System
This device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380).

Treatment: Devices: FES-assisted cycling
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).

Other interventions: Trunk and upper and lower limb exercises
This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.

Other interventions: Upper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent
and have completed their primary rehabilitation

2. Are 18 years or older and able to give informed consent

3. Have a complete or incomplete spinal cord injury between C6 and T12 (as per the
International Standardised Neurological Assessment for SCI)

4. Are able and willing to attend an exercise program 3 times per week for 12 weeks

5. Are considered by their medical consultant to be fit to undertake the exercise program
(documented approval by medical consultant required).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have brachial plexus, cauda equina, or peripheral nerve injury

2. Have had recent major trauma or surgery within the last 6 months

3. Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer
Advisory Panel classification

4. Are post-menopausal at time of injury (females)

5. Have BMI at injury falling below lower threshold of healthy adult reference range

6. Have endocrinopathy or metabolic disorders of bone, such as Paget's disease, lytic or
renal bone disease and senile osteoporosis

7. have medical history of exposure to medication(s) known to affect mineral ion or bone
metabolism

8. Have chronic systemic diseases, e.g. Hep C, HIV-AIDs

9. Have significant impairment or disability, including physical, neurological or
psychological impairments

10. Have a history of long bone fracture, or family history of fragility fracture

11. Have medical fragility, e.g. BMI falling below lower threshold of healthy adult
reference range, or history of recurrent hospital readmissions.

12. Have extensive fixed contractures in upper or lower limbs

13. Have severe spasticity

14. Have uncontrolled neuropathic pain

15. Are likely to experience clinically significant autonomic dysreflexia and/or
hypotension in response to electrical stimulation or prolonged upright posture

16. Are unable to attend the 6-month and 12 month follow-up assessments at their treating
spinal unit

17. Have any contraindications to FES such as cardiac pacemaker, epilepsy, lower limb
fracture or pregnancy

18. Have intracranial metal implants (for TMS only)

19. Have any other serious medical condition including malignancies, psychiatric,
behavioural 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.

20. Are participating in any other therapy (including alternative therapies) or taking
medications (including herbal preparations) that are not considered to be standard
care as per the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Spinal Unit, Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Royal Rehabilitation Centre Sydney - Sydney
Recruitment hospital [3] 0 0
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre - Northfield
Recruitment hospital [4] 0 0
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre - Kew
Recruitment hospital [5] 0 0
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital - Shenton Park
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Northfield
Recruitment postcode(s) [4] 0 0
3101 - Kew
Recruitment postcode(s) [5] 0 0
- Shenton Park
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hampstead Rehabilitation Centre Adelaide
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Shenton Park Rehabilitation Centre Perth
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Royal Rehabilitation Centre Sydney
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Prince of Wales Hospital, Sydney
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Burwood Hospital, Christchurch, New Zealand
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study is a multi-centre, assessor-blind, randomised controlled phase III trial in
patients with with complete or incomplete spinal cord injury between C6 and T12. A total of
188 participants will be randomised into two groups, the experimental group and the control
group. The control group participants will receive an upper body strength and fitness
program, conducted for 2-3 hours, three times per week for 12 weeks, while the experimental
group participants will receive a comprehensive full body exercise program, conducted for 2-3
hours, three times per week for 12 weeks.

The main objective of this study is to determine if the experimental exercise program is more
effective than the upper body strength and fitness program in promoting neurological
improvement in participants with spinal cord injury.

Total study duration is 3.5 years, including a 24 month recruitment period, a 12-week
treatment period followed by 6 month and 12 month (from baseline) follow up assessments.

Participants will be assessed by a blinded assessor (the assessor will not know which group
the participants are in) using standard physiotherapy, neurophysiological, fitness and
functional tests, psychological and quality of life questionnaires, as well as tests of
immune function and bone structure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01236976
Trial related presentations / publications
Galea MP, Dunlop SA, Davis GM, Nunn A, Geraghty T, Hsueh YS, Churilov L. Intensive exercise program after spinal cord injury ("Full-On"): study protocol for a randomized controlled trial. Trials. 2013 Sep 11;14:291. doi: 10.1186/1745-6215-14-291.
Public notes

Contacts
Principal investigator
Name 0 0
Prof Mary Galea
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01236976