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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01236976
Ethics application status
Date submitted
8/11/2010
Date registered
9/11/2010

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
Government body
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
Government body
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregate data only. Individual participant data will not be provided as per the ethics approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Galea MP, Dunlop SA, Geraghty T, Davis GM, Nunn A,... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT01236976