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Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Compex Motion Stimulator
Compex Motion Stimulator
Conventional Exercise
Sponsored by
Ontario Neurotrauma Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

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: 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

Sites / Locations

  • Lyndhurst Centre, Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

FES training

Control Group training

Arm Description

Arm 1 receives functional electrical stimulation while walking on body weight suspension training.

Aerobic and resistance training program

Outcomes

Primary Outcome Measures

Whole body muscle mass via dual-energy x-ray absorptiometry
Bone density at different hip, spine, proximal and distal femur and proximal Tibia 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

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).

Full Information

First Posted
September 12, 2005
Last Updated
February 25, 2013
Sponsor
Ontario Neurotrauma Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00201968
Brief Title
Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
Official Title
Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ontario Neurotrauma Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

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 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FES training
Arm Type
Other
Arm Description
Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
Arm Title
Control Group training
Arm Type
Other
Arm Description
Aerobic and resistance training program
Intervention Type
Device
Intervention Name(s)
Compex Motion Stimulator
Other Intervention Name(s)
Brand Name: Loko 70, Code Names: BWST, FES
Intervention Description
Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
Intervention Type
Device
Intervention Name(s)
Compex Motion Stimulator
Other Intervention Name(s)
FES, Electrical stimulation
Intervention Description
Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
Intervention Type
Other
Intervention Name(s)
Conventional Exercise
Other Intervention Name(s)
Conventional Physiotherapy
Intervention Description
An aerobic and resistance training program.
Primary Outcome Measure Information:
Title
Whole body muscle mass via dual-energy x-ray absorptiometry
Time Frame
Baseline, 4 month and 12 months
Title
Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry
Time Frame
Baseline, 4 month and 12 months
Title
Bone density, bone geometry and muscle area via computed tomography,
Time Frame
Baseline, 4 month and 12 months
Title
Spasticity via Ashworth Scale and Pendulum Test, and
Time Frame
Baseline, 4 months, 6 months and 12 months
Title
Factor analysis of electromyography and kinematics of gait.
Time Frame
Baseline, 4months and 6 months
Secondary Outcome Measure Information:
Title
Incidence of urinary tract infections,
Time Frame
Over 12 months
Title
Spinal cord independence measure,
Time Frame
Baseline and 12 months
Title
Urinary N-telopeptide and serum osteocalcin,
Time Frame
Baseline, 4 month, 6 month and 12 months
Title
Timed up and go and two-minute walk test (functional mobility),
Time Frame
Baseline, 4 months, 6 months and 12 months
Title
Incidence of pressure sores,
Time Frame
Over 12 months
Title
Reintegration to normal living index,
Time Frame
Baseline, 4, 6 and 12 months
Title
Satisfaction with life scale,
Time Frame
Baseline, 4 , 6 and 12 months
Title
Instrumental Activities of Daily Living SubScale,
Time Frame
Baseline, 4, 6 and 12 months
Title
Craig Handicap assessment and reporting technique, and
Time Frame
Baseline, 4, 6 and 12 months
Title
client perception of treatment (qualitative).
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milos Popovic, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndhurst Centre, Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25229735
Citation
Kapadia N, Masani K, Catharine Craven B, Giangregorio LM, Hitzig SL, Richards K, Popovic MR. A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. J Spinal Cord Med. 2014 Sep;37(5):511-24. doi: 10.1179/2045772314Y.0000000263.
Results Reference
derived
PubMed Identifier
23031172
Citation
Giangregorio L, Craven C, Richards K, Kapadia N, Hitzig SL, Masani K, Popovic MR. A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: effects on body composition. J Spinal Cord Med. 2012 Sep;35(5):351-60. doi: 10.1179/2045772312Y.0000000041.
Results Reference
derived

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Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury

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