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

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Therastride Treadmill System

FES-assisted cycling

Trunk and upper and lower limb exercises

Upper body strength and fitness program

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent and have completed their primary rehabilitation
Are 18 years or older and able to give informed consent
Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI)
Are able and willing to attend an exercise program 3 times per week for 12 weeks
Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by medical consultant required).

Exclusion Criteria:

Have brachial plexus, cauda equina, or peripheral nerve injury
Have had recent major trauma or surgery within the last 6 months
Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification
Are post-menopausal at time of injury (females)
Have BMI at injury falling below lower threshold of healthy adult reference range
Have endocrinopathy or metabolic disorders of bone, such as Paget's disease, lytic or renal bone disease and senile osteoporosis
have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism
Have chronic systemic diseases, e.g. Hep C, HIV-AIDs
Have significant impairment or disability, including physical, neurological or psychological impairments
Have a history of long bone fracture, or family history of fragility fracture
Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions.
Have extensive fixed contractures in upper or lower limbs
Have severe spasticity
Have uncontrolled neuropathic pain
Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture
Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit
Have any contraindications to FES such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy
Have intracranial metal implants (for TMS only)
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.
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.

Sites / Locations

Spinal Unit, Prince of Wales Hospital
Royal Rehabilitation Centre Sydney
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
Burwood Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To determine the relative effectiveness of a comprehensive exercise program compared to a generic upper body strength and fitness training program on neurological improvement.

Secondary Outcome Measures

Full Information

NCT ID

NCT01236976

First Posted

November 8, 2010

Last Updated

April 28, 2021

Sponsor

University of Melbourne

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01236976

Brief Title

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

Acronym

SCIPAFull-On

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Melbourne

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Therastride Treadmill System

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

FES-assisted cycling

Intervention Description

This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).

Intervention Type

Other

Intervention Name(s)

Trunk and upper and lower limb exercises

Intervention Description

This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.

Intervention Type

Other

Intervention Name(s)

Upper body strength and fitness program

Intervention Description

This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have sustained a traumatic spinal cord injury a minimum of 6 months prior to consent and have completed their primary rehabilitation Are 18 years or older and able to give informed consent Have a complete or incomplete spinal cord injury between C6 and T12 (as per the International Standardised Neurological Assessment for SCI) Are able and willing to attend an exercise program 3 times per week for 12 weeks Are considered by their medical consultant to be fit to undertake the exercise program (documented approval by medical consultant required). Exclusion Criteria: Have brachial plexus, cauda equina, or peripheral nerve injury Have had recent major trauma or surgery within the last 6 months Have an existing pressure ulcer Stage 3 or 4 according to the National Pressure Ulcer Advisory Panel classification Are post-menopausal at time of injury (females) Have BMI at injury falling below lower threshold of healthy adult reference range Have endocrinopathy or metabolic disorders of bone, such as Paget's disease, lytic or renal bone disease and senile osteoporosis have medical history of exposure to medication(s) known to affect mineral ion or bone metabolism Have chronic systemic diseases, e.g. Hep C, HIV-AIDs Have significant impairment or disability, including physical, neurological or psychological impairments Have a history of long bone fracture, or family history of fragility fracture Have medical fragility, e.g. BMI falling below lower threshold of healthy adult reference range, or history of recurrent hospital readmissions. Have extensive fixed contractures in upper or lower limbs Have severe spasticity Have uncontrolled neuropathic pain Are likely to experience clinically significant autonomic dysreflexia and/or hypotension in response to electrical stimulation or prolonged upright posture Are unable to attend the 6-month and 12 month follow-up assessments at their treating spinal unit Have any contraindications to FES such as cardiac pacemaker, epilepsy, lower limb fracture or pregnancy Have intracranial metal implants (for TMS only) 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. 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.

Overall Study Officials: