Full Text View
Tabular View
No Study Results Posted
Related Studies
Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
This study is currently recruiting participants.
Verified by Ontario Neurotrauma Foundation, August 2008
First Received: September 12, 2005   Last Updated: August 19, 2008   History of Changes
Sponsored by: Ontario Neurotrauma Foundation
Information provided by: Ontario Neurotrauma Foundation
ClinicalTrials.gov Identifier: NCT00201968
  Purpose

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
Spinal Cord Injury
Device: Compex Motion Stimulator
Other: Conventional Exercise
Phase IV

MedlinePlus related topics: Spinal Cord Injuries
U.S. FDA Resources
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

Further study details as provided by Ontario Neurotrauma Foundation:

Primary Outcome Measures:
  • All of the measures below at four months:
  • Whole body muscle mass via dual-energy x-ray absorptiometry including
  • Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry,
  • Bone density, bone geometry and muscle area via computed tomography,
  • Spasticity via Ashworth Scale and Pendulum Test, and
  • Factor analysis of electromyography and kinematics of gait.

Secondary Outcome Measures:
  • All of the measures above at six months, and twelve months, as well as the measures below at four months, six months and twelve months:
  • incidence of urinary tract infections,
  • spinal cord independence measure,
  • urinary N-telopeptide and serum osteocalcin,
  • timed up and go and two-minute walk test (functional mobility),
  • incidence of pressure sores,
  • reintegration to normal living index,
  • satisfaction with life scale,
  • Instrumental Activities of Daily Living SubScale,
  • Craig Handicap assessment and reporting technique, and
  • client perception of treatment (qualitative).

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
1
Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
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.
2
Aerobic and resistance training program
Other: Conventional Exercise
An aerobic and resistance training program.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • incomplete spinal cord lesion of sudden onset between C6 and T12 that is motor incomplete (grade C or D on the ASIA neurological impairment scale).

The injury must have occurred at least two years prior to recruitment

Exclusion Criteria:

  • contraindications for FES, such as cardiac pacemakers, skin lesions or rush at potential electrode sites, or denervation of targeted muscles.
  • pressure ulcers anywhere on the lower extremities
  • hypertension that is uncontrolled
  • symptoms of orthostatic hypotension when standing for 15 minutes
  • susceptibility to autonomic dysreflexia, requiring medication.
  • if there is a history of cardiovascular disease, participants must obtain medical clearance from their physician before inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201968

Contacts
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

Locations
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            
Sponsors and Collaborators
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Milos Popovic, PhD University of Toronto
  More Information

No publications provided

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

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Neoplasm Metastasis
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 07, 2009