SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury (SCIPAFull-On)

April 28, 2021 updated by: Mary Galea, University of Melbourne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 articipants 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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia
        • Spinal Unit, Prince of Wales Hospital
      • Sydney, New South Wales, Australia
        • Royal Rehabilitation Centre Sydney
    • South Australia
      • Northfield, South Australia, Australia
        • South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
    • Victoria
      • Kew, Victoria, Australia, 3101
        • Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
    • Western Australia
      • Shenton Park, Western Australia, Australia
        • Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
  • New Zealand
      • Christchurch, New Zealand
        • Burwood Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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).
Device: FES-assisted cycling
This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).
Other: 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: 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.
Other: Upper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

Austin Health
Prince of Wales Hospital, Sydney
Burwood Hospital, Christchurch, New Zealand
Hampstead Rehabilitation Centre Adelaide
Shenton Park Rehabilitation Centre Perth
Royal Rehabilitation Centre Sydney

Investigators

  • Principal Investigator: Prof Mary Galea, University of Melbourne
  • Principal Investigator: Prof Glen Davis, University of Sydney
  • Principal Investigator: Prof Sarah Dunlop, The University of Western Australia
  • Principal Investigator: Dr Andrew Nunn, Austin Health
  • Principal Investigator: Dr Tim Geraghty, Princess Alexandra Hospital Brisbane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (ESTIMATE)

November 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCIPA Full-On

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate data only. Individual participant data will not be provided as per the ethics approval.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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