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Sponsored by: |
Ontario Neurotrauma Foundation |
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Information provided by: | Ontario Neurotrauma Foundation |
ClinicalTrials.gov Identifier: | NCT00201968 |
The purpose of this study is to evaluate whether an aerobic and resistance training program or a functional electrical stimulation-assisted Walking program is more effective for reducing health complications related to spinal cord injury, for example, the occurrence of bladder infections, pressure sores and/or frequency of spasms. It is hypothesized that the functional electrical stimulation-assisted walking will have a greater impact on secondary complications than the aerobic and resistance training program.
Condition | Intervention | Phase |
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Spinal Cord Injury |
Device: Compex Motion Stimulator Other: Conventional Exercise |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury |
Estimated Enrollment: | 32 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
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Device: Compex Motion Stimulator
FES applied to the lower limbs of SCI individuals in order to stimulate walking while on body weight suspension training (BWST).
Device: Compex Motion Stimulator
Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
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2
Aerobic and resistance training program
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Other: Conventional Exercise
An aerobic and resistance training program.
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A barrier to maintaining health status and active social participation in the community for individuals with spinal cord injury (SCI) is the broad number of secondary medical complications typically associated with their injury, such as bone loss, spasticity, urinary tract infections and pressure sores.
Functional electrical stimulation (FES) is an intervention that applies short current pulses to muscles and causes them to contract. FES can be applied to individuals with SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner.
Pilot work conducted by our research group suggests that applying FES to augment functional improvement often reduces incidents of secondary complications such as spasticity, pressure sores, and swelling of the legs. Specifically, functional and meaningful walking tasks performed on a regular basis with the help of FES therapy have the potential to improve overall physical and psychological well being of persons with incomplete SCI. This study seeks to demonstrate that thrice-weekly FES training for 4 months can restore/improve walking function in chronic, incomplete SCI individuals and that this therapy will considerably reduce the occurrences of secondary complications due to SCI. This will subsequently promote opportunities for active social participation and enhance the quality of life for SCI consumers. Comparison: 32 individuals with chronic, incomplete SCI will be randomized to either thrice-weekly FES therapy OR thrice-weekly aerobic and resistance training. The study will determine which therapy is superior for improving walking function and reducing secondary complications associated with SCI after 4 months of training, and after 2-month and 8-month follow-up periods.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The injury must have occurred at least two years prior to recruitment
Exclusion Criteria:
Contact: Naaz Kapadia, MSc | 416-597-3422 ext 6310 | kapadia.naaz@torontorehab.on.ca |
Contact: Lora Giangregorio, PhD | 519-362-5672 | lmgiangr@healthy.uwaterloo.ca |
Canada, Ontario | |
Lyndhurst Centre, Toronto Rehabilitation Institute | Recruiting |
Toronto, Ontario, Canada, M4G 3V9 | |
Contact: Naaz Kapadia, MSc 416-597-3422 ext 6310 kapadia.naaz@torontorehab.on.ca | |
Contact: Milos Popovic, PhD 416-978-6676 milos.popovic@utoronto.ca | |
Sub-Investigator: Lora Giangregorio, PhD | |
Sub-Investigator: Adam Thrasher, PhD | |
Sub-Investigator: Beverly C Craven, MD, MSc | |
Sub-Investigator: Kathy Boschen, Phd | |
Sub-Investigator: Mark Tonack, MSc |
Principal Investigator: | Milos Popovic, PhD | University of Toronto |
Responsible Party: | Toronto Rehab: Lyndhurst Centre ( Dr. Milos R. Popovic ) |
Study ID Numbers: | REL-2004-3 |
Study First Received: | September 12, 2005 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00201968 History of Changes |
Health Authority: | Canada: Health Canada |
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries Neoplasm Metastasis |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |