Recruiting

FES

Sponsor:

Toronto Rehabilitation Institute

Code:

NCT00552916

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

Interventions

Compex Motion Stimulator

Compex Motion Stimulator

Study Details

Brief summary:

The purpose of this study is to determine if a form of exercise,known as electrical stimulation can improve walking function and other important health outcomes. The hypothesis is that electrical stimulation can enhance the ability to walk for stroke survivors who are unable to walk on their on their own.

Conditions

Stroke

Study ID

NCT00552916

Start date

Oct, 2007

Status verified date

Aug, 2008

Completion date

Nov, 2010

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Hemiplegic stroke at least 12 months prior to joining the study.
  • Age 65 years or greater.
  • Ability to follow instructions and to devote his/her attention to therapy.
  • Ability to understand instructions in English and able to provide informed consent.

Exclusion Criteria:

  • Severe difficulties with attention such that informed consent cannot be obtained, or that safety or communication would be comprised.
  • Ability to walk more that 10 meters during a two minute walk with an average speed greater than 0.8 m/s.
  • The presence of skin rashes, allergies or bruises where electrodes would be placed.
  • History of seizures, edema in paralyzed limbs or co-morbidities such as Parkinson's Disease, cancer or osteoarthritis to be confirmed by attending physiatrist.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 1

Participants will be randomized to either an intervention arm where they will receive 'true' FES and the other control arm where they will receive 'false' FES. The sham group will receive 'false' FES.

other: 2

The intervention group will receive 'true' FES

Interventions

Compex Motion Stimulator

'True' Functional Electrical Stimulation Assisted Walking

Compex Motion Stimulator

'False' FES

Primary outcome measure

  • The ability of FES-Assisted Walking to stimulate or improve walking ability using a dichotomous outcome i.e. yes/no stimulation or improvement of walking ability on a two-minute walk test. [ Time Frame: Test performed weekly during 8-week period as well as at 2 month and 6 month time point. ]

Central Contacts and Locations

Central contacts

Naaz Kapadia, MSc

416-597-3422kapadia.naaz@torontorehab.on.ca

Locations

Toronto Rehabilitation Institute: Lyndhurst Centre

Recruiting

Toronto, Ontario, Canada, M4G 3V9

Contacts

Naaz Kapadia, MSc

416-597-3422kapadia.naaz@torontorehab.on.ca

Milos R Popovic, PhD

milos.popovic@utoronto.ca

More Information

Sponsor

Toronto Rehabilitation Institute

Last update posted

Aug 20, 2008

Last verified

Aug, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toronto Rehabilitation Institute on 2008-08-20.