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

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.

Conditions

• Spinal Cord Injury

Interventions

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

Upper body strength and fitness program

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

Sponsors & Collaborators

• Austin Health

  collaborator OTHER_GOV

• Hampstead Rehabilitation Centre Adelaide

  collaborator UNKNOWN

• Shenton Park Rehabilitation Centre Perth

  collaborator UNKNOWN

• Royal Rehabilitation Centre Sydney

  collaborator UNKNOWN

• Prince of Wales Hospital, Sydney

  collaborator OTHER_GOV

• Burwood Hospital, Christchurch, New Zealand

  collaborator OTHER

• University of Melbourne

  lead OTHER

Principal Investigators

• Prof Mary Galea · University of Melbourne

• Prof Glen Davis · University of Sydney

• Prof Sarah Dunlop · The University of Western Australia

• Dr Andrew Nunn · Austin Health

• Dr Tim Geraghty · Princess Alexandra Hospital Brisbane

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2012-12-31

Completion

2016-06-30

Countries

• Australia
• New Zealand

Study Locations