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

NCT00201968 | Unknown Phase 4 DMC

• 1 other identifier: REL-2004-3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (5)

• Whole body muscle mass via dual-energy x-ray absorptiometry

  Baseline, 4 month and 12 months

• Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry

  Baseline, 4 month and 12 months

• Bone density, bone geometry and muscle area via computed tomography,

  Baseline, 4 month and 12 months

• Spasticity via Ashworth Scale and Pendulum Test, and

  Baseline, 4 months, 6 months and 12 months

• Factor analysis of electromyography and kinematics of gait.

  Baseline, 4months and 6 months

Secondary Outcomes (10)

• Incidence of urinary tract infections,

  Over 12 months

• Spinal cord independence measure,

  Baseline and 12 months

• Urinary N-telopeptide and serum osteocalcin,

  Baseline, 4 month, 6 month and 12 months

• Timed up and go and two-minute walk test (functional mobility),

  Baseline, 4 months, 6 months and 12 months

• Incidence of pressure sores,

  Over 12 months

Study Arms (2)

FES training

OTHER

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

Device: Compex Motion Stimulator

Control Group training

OTHER

Aerobic and resistance training program

Other: Conventional Exercise

Interventions

Compex Motion Stimulator DEVICE

Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill

Also known as: Brand Name: Loko 70, Code Names: BWST, FES

FES training

Conventional Exercise OTHER

An aerobic and resistance training program.

Also known as: Conventional Physiotherapy

Control Group training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Neurotrauma Foundation: lead

Study Sites (1)

Lyndhurst Centre, Toronto Rehabilitation Institute

Toronto, Ontario, M4G 3V9, Canada

Location

Related Publications (2)

• 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.

  PMID: 25229735 DERIVED

• 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.

  PMID: 23031172 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Milos Popovic, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2005
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

CA (1)