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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00201968
• Other study ID #: REL-2004-3
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 25, 2013
• Start date: April 2005
• Est. completion date: April 2013

Study information

• Verified date: February 2013
• Source: Ontario Neurotrauma Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Compex Motion Stimulator
Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
• Compex Motion Stimulator
Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.

Other:
• Conventional Exercise
An aerobic and resistance training program.

Locations

Country	Name	City	State
Canada	Lyndhurst Centre, Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Neurotrauma Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body muscle mass via dual-energy x-ray absorptiometry		Baseline, 4 month and 12 months	No
Primary	Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry		Baseline, 4 month and 12 months	No
Primary	Bone density, bone geometry and muscle area via computed tomography,		Baseline, 4 month and 12 months	No
Primary	Spasticity via Ashworth Scale and Pendulum Test, and		Baseline, 4 months, 6 months and 12 months	No
Primary	Factor analysis of electromyography and kinematics of gait.		Baseline, 4months and 6 months	No
Secondary	Incidence of urinary tract infections,		Over 12 months	No
Secondary	Spinal cord independence measure,		Baseline and 12 months	No
Secondary	Urinary N-telopeptide and serum osteocalcin,		Baseline, 4 month, 6 month and 12 months	No
Secondary	Timed up and go and two-minute walk test (functional mobility),		Baseline, 4 months, 6 months and 12 months	No
Secondary	Incidence of pressure sores,		Over 12 months	No
Secondary	Reintegration to normal living index,		Baseline, 4, 6 and 12 months	No
Secondary	Satisfaction with life scale,		Baseline, 4 , 6 and 12 months	No
Secondary	Instrumental Activities of Daily Living SubScale,		Baseline, 4, 6 and 12 months	No
Secondary	Craig Handicap assessment and reporting technique, and		Baseline, 4, 6 and 12 months	No
Secondary	client perception of treatment (qualitative).		At 12 months	No