Treadmill Training With Functional Electric Stimulation After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Treadmill training with functional electrical stimulation
* Other: Treadmill training without functional electrical stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treadmill training with functional electrical stimulation<br>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<br> <br> |
| Active Comparator: treadmill training without functional electrical stimulation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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