SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury (SCIPA Full-On)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01236976|
Recruitment Status : Unknown
Verified August 2010 by University of Melbourne.
Recruitment status was: Recruiting
First Posted : November 9, 2010
Last Update Posted : August 5, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: Therastride Treadmill System Device: FES-assisted cycling Other: Trunk and upper and lower limb exercises Other: Upper body strength and fitness program||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||SCIPA Full-On :Intensive Exercise Program After Spinal Cord Injury|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
Experimental: Intervention Group
Participants in Group A will receive a triad of interventions comprising body weight supported treadmill training (BWSTT), functional electrical stimulation (FES)-assisted cycling, and trunk and upper and lower extremity exercise. These interventions will be provided at the spinal unit.
It is neither feasible nor desirable that every participant receives identical intervention because of the expected differences in impairments and activity limitations that he/she experiences. Project staff will use their clinical judgment to select exercises suitable for each participant and to progress them as appropriate. All exercises selected will be documented in the participant source notes.
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 has adjustable ergonomic seating for the therapists, a dedicated computer, surge protector, battery backup, custom software and controls, and a closed-loop feedback system. A therapist/assistant is positioned behind the participant to stabilise the pelvis and trunk, and to assist with appropriate weight shifting and hip rotation during the step cycle. Two additional therapists are seated in front of the participant to provide manual assistance for the lower limbs to facilitate knee extension during stance and knee flexion and toe clearance during swing, maintaining appropriate alignment of the limbs. A fourth person controls the treadmill. This system is being used in US universities and rehabilitation facilities throughout North America and 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). Surface electrodes will be applied to the quadriceps, gluteal, hamstrings and calf muscles according to a standardized protocol. The pedal cadence will be set to 15-50 rev•min-1. Stimulation intensity will be gradually increased to a maximum of 140 mA with a pulse width of 0.3ms and frequency of 35Hz (Eser et al. 2003; Fornusek & Davis, 2008). Participants will exercise at the maximal power output possible at their level of recovery. Participants will commence with 10 minutes of training and gradually build up to a period of 30 minutes. The frequency, power output at each minute, and training duration will be recorded at each training session.
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. These may be provided in lying (e.g. supine, prone) and in weight-bearing positions (e.g. kneeling, standing). Task-specific practice of functional tasks, involving moving the upper body over and outside the base of support, will also be undertaken. Participants may also be given exercises in motor imagery, imagining movements of their body
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.
The participants will be supervised by a therapist and/or clinical exercise instructor and exercises will be progressed as appropriate to build strength and endurance. Guidelines for the content and delivery of exercises will be clearly outlined in a handbook to ensure standardisation across sites.
Other: Upper body strength and fitness program
This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236976
|Contact: Prof Mary Galea||+61 3 9490 firstname.lastname@example.org|
|Contact: Prof Glen Davis||+61 2 9351 9466||Glen.Davis@sydney.edu.au|
|Australia, New South Wales|
|Spinal Unit, Prince of Wales Hospital||Not yet recruiting|
|Randwick, New South Wales, Australia|
|Contact: Julia Batty +61 2 9382 5900 email@example.com|
|Contact: Fernanda Di Natal +61 2 9382 5900 Fernanda.diNatal@sesiahs.health.nsw.gov.au|
|Principal Investigator: Julia Batty|
|Sub-Investigator: Fernanda Di Natal|
|Royal Rehabilitation Centre Sydney||Not yet recruiting|
|Sydney, New South Wales, Australia|
|Contact: Sarah Fereday +61 2 9808 9273 Sarah.Fereday@royalrehab.com.au|
|Contact: Clare Goodman +61 2 9808 9360 firstname.lastname@example.org|
|Principal Investigator: Sarah Fereday|
|Sub-Investigator: Clare Goodman|
|Australia, South Australia|
|South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre||Recruiting|
|Northfield, South Australia, Australia|
|Contact: Ruth Marshall +61 8 8222 1629 email@example.com|
|Contact: Jillian Clark +61 8 8222 1860 Jillian.Clark@health.sa.gov.au|
|Principal Investigator: Ruth Marshall|
|Sub-Investigator: Jillian Clark|
|Sub-Investigator: Graig Drury|
|Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre||Recruiting|
|Kew, Victoria, Australia, 3101|
|Contact: Mary Galea +61 3 9490 7645 firstname.lastname@example.org|
|Contact: Melanie Hurley +61 9490 7647 email@example.com|
|Principal Investigator: Mary Galea|
|Sub-Investigator: Andrew Nunn|
|Australia, Western Australia|
|Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital||Recruiting|
|Shenton Park, Western Australia, Australia|
|Contact: John Buchanan +61 8 9382 7171 John.Buchanan@health.wa.gov.au|
|Contact: Kate Wisbey +61 8 9382 7307 Kate.Wisbey@health.wa.gov.au|
|Principal Investigator: John Buchanan|
|Sub-Investigator: Sarah Dunlop|
|Sub-Investigator: Garry Allison|
|Christchurch, New Zealand|
|Contact: Jo Nunnerley +64 03 3836833 Joanne.Nunnerley@cdhb.govt.nz|
|Contact: Jacqui Prakasim Jacqueline.Prakasim@middlemore.co.nz|
|Principal Investigator: Rick Acland|
|Sub-Investigator: Anne Sinnott|
|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|