Spinal Cord InjuryPhase 4NCT00201968
Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
A Phase 4 study testing Compex Motion Stimulator and Conventional Exercise in people with Spinal Cord Injury, run by Ontario Neurotrauma Foundation at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Compex Motion Stimulator and Conventional Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lyndhurst Centre, Toronto Rehabilitation Institute
Toronto, Ontario, M4G 3V9
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Compex Motion Stimulator, Conventional Exercise
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compex Motion StimulatorDevice
Also called Brand Name: Loko 70, Code Names: BWST, FES
Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
Compex Motion StimulatorDevice
Also called FES, Electrical stimulation
Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
Conventional ExerciseOther
Also called Conventional Physiotherapy
An aerobic and resistance training program.
| Study group | Role | What they receive |
|---|---|---|
| FES training | Other | Arm 1 receives functional electrical stimulation while walking on body weight suspension training. Receives: Device: Compex Motion Stimulator |
| Control Group training | Other | Aerobic and resistance training program Receives: Other: Conventional Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body muscle mass via dual-energy x-ray absorptiometry
Measured: Baseline, 4 month and 12 months
Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry
Measured: Baseline, 4 month and 12 months
Bone density, bone geometry and muscle area via computed tomography,
Measured: Baseline, 4 month and 12 months
Spasticity via Ashworth Scale and Pendulum Test, and
Measured: Baseline, 4 months, 6 months and 12 months
Factor analysis of electromyography and kinematics of gait.
Measured: Baseline, 4months and 6 months
Secondary outcomes (10)
Incidence of urinary tract infections,
Measured: Over 12 months
Spinal cord independence measure,
Measured: Baseline and 12 months
Urinary N-telopeptide and serum osteocalcin,
Measured: Baseline, 4 month, 6 month and 12 months
Timed up and go and two-minute walk test (functional mobility),
Measured: Baseline, 4 months, 6 months and 12 months
Incidence of pressure sores,
Measured: Over 12 months
Reintegration to normal living index,
Measured: Baseline, 4, 6 and 12 months
Satisfaction with life scale,
Measured: Baseline, 4 , 6 and 12 months
Instrumental Activities of Daily Living SubScale,
Measured: Baseline, 4, 6 and 12 months
Craig Handicap assessment and reporting technique, and
Measured: Baseline, 4, 6 and 12 months
client perception of treatment (qualitative).
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ontario Neurotrauma Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milos Popovic, Toronto Rehabilitation Institute
- Investigators
- Milos Popovic, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201968
- Sponsor's protocol ID
- REL-2004-3
- Status last verified
- Feb 2013
- First submitted
- 12 Sep 2005
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25229735Giangregorio 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.
PubMed 23031172
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00201968
- Acronym / sponsor ID
- REL-2004-3
- Conditions
- Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ontario Neurotrauma FoundationUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES training | Other | Device: Compex Motion StimulatorArm 1 receives functional electrical stimulation while walking on body weight suspension training. |
| Control Group training | Other | Other: Conventional ExerciseAerobic and resistance training program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compex Motion StimulatorAlso: Brand Name: Loko 70, Code Names: BWST, FESFunctional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill | Device | FES training |
| Compex Motion StimulatorAlso: FES, Electrical stimulationSpecific functional electrical stimulation program developed for each individual applied while walking on the treadmill. | Device | FES training |
| Conventional ExerciseAlso: Conventional PhysiotherapyAn aerobic and resistance training program. | Other | Control Group training |
Primary outcome
Whole body muscle mass via dual-energy x-ray absorptiometry
Time frame: Baseline, 4 month and 12 months
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
Bone density, bone geometry and muscle area via computed tomography,
Time frame: Baseline, 4 month and 12 months
Spasticity via Ashworth Scale and Pendulum Test, and
Time frame: Baseline, 4 months, 6 months and 12 months
Factor analysis of electromyography and kinematics of gait.
Time frame: Baseline, 4months and 6 months
10 secondary outcomes
Incidence of urinary tract infections,
Time frame: Over 12 months
Spinal cord independence measure,
Time frame: Baseline and 12 months
Urinary N-telopeptide and serum osteocalcin,
Time frame: Baseline, 4 month, 6 month and 12 months
Timed up and go and two-minute walk test (functional mobility),
Time frame: Baseline, 4 months, 6 months and 12 months
Incidence of pressure sores,
Time frame: Over 12 months
Reintegration to normal living index,
Time frame: Baseline, 4, 6 and 12 months
Satisfaction with life scale,
Time frame: Baseline, 4 , 6 and 12 months
Instrumental Activities of Daily Living SubScale,
Time frame: Baseline, 4, 6 and 12 months
Craig Handicap assessment and reporting technique, and
Time frame: Baseline, 4, 6 and 12 months
client perception of treatment (qualitative).
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
- Derived from this study: PubMed 25229735Kapadia 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.
- Derived from this study: PubMed 23031172Giangregorio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milos Popovic, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compex Motion Stimulator and Conventional Exercise in people with Spinal Cord Injury, run by Ontario Neurotrauma Foundation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body muscle mass via dual-energy x-ray absorptiometry (time frame: Baseline, 4 month and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201968, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.