Back to resultsTreadmill Training With Functional Electric Stimulation After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treadmill training with functional electrical stimulation
Treadmill training without functional electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
treadmill training with functional electrical stimulation
treadmill training without functional electrical stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
N1 latency of somatosensory evoked potential
N1P1 amplitude of somatosensory evoked potential
motor threshold of motor evoked potential
map size of motor evoked potential
Secondary Outcome Measures
Fugl-Meyer Assessment
Motricity Index
Berg Balance Scale
walking speed
Modified-Emory Functional Ambulation Profile
Measures a patient's ability to walk through 5 commonly experienced types of terrain.
Full Information
NCT ID
NCT02812472
First Posted
June 15, 2016
Last Updated
June 21, 2016
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT02812472
Brief Title
Treadmill Training With Functional Electric Stimulation After Stroke
Official Title
Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treadmill training with functional electrical stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
treadmill training without functional electrical stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill training with functional electrical stimulation
Intervention Type
Other
Intervention Name(s)
Treadmill training without functional electrical stimulation
Primary Outcome Measure Information:
Title
N1 latency of somatosensory evoked potential
Time Frame
Change from baseline at 4 weeks
Title
N1P1 amplitude of somatosensory evoked potential
Time Frame
Change from baseline at 4 weeks
Title
motor threshold of motor evoked potential
Time Frame
Change from baseline at 4 weeks
Title
map size of motor evoked potential
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Time Frame
Change from baseline at 4 weeks
Title
Motricity Index
Time Frame
Change from baseline at 4 weeks
Title
Berg Balance Scale
Time Frame
Change from baseline at 4 weeks
Title
walking speed
Time Frame
Change from baseline at 4 weeks
Title
Modified-Emory Functional Ambulation Profile
Description
Measures a patient's ability to walk through 5 commonly experienced types of terrain.
Time Frame
Change from baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Treadmill Training With Functional Electric Stimulation After Stroke
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