Treadmill Training With Functional Electric Stimulation After Stroke

June 21, 2016 updated by: Yea-Ru Yang, National Yang Ming University

Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke

The purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of unilateral hemiparesis secondary to cerebrovascular accident with post-onset duration of more than 6 months
  • ability to walk independently for at least 6 meters with or without use of walking aids
  • ability to follow simple verbal commands or instructions

Exclusion Criteria:

  • unstable medical conditions
  • history of other diseases known to interfere with participation in the study
  • past history of a seizure
  • history of skin allergy to electrode
  • use of a cardiac pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treadmill training with functional electrical stimulation
Subjects in the experimental group received additional treadmill training with functional electric stimulation for 25 minutes per session, followed by 5 minutes cool down for 12 sessions.
Other: Treadmill training with functional electrical stimulation
Active Comparator: treadmill training without functional electrical stimulation
Subjects in the control group received additional treadmill training without functional electric stimulation for 25 minutes per session, followed by 5 minutes cool down for 12 sessions.
Other: Treadmill training without functional electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
N1 latency of somatosensory evoked potential
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
N1P1 amplitude of somatosensory evoked potential
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
motor threshold of motor evoked potential
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
map size of motor evoked potential
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Motricity Index
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Berg Balance Scale
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
walking speed
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Modified-Emory Functional Ambulation Profile
Time Frame: Change from baseline at 4 weeks
Measures a patient's ability to walk through 5 commonly experienced types of terrain.
Change from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 960053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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