Treadmill Training With Functional Electric Stimulation After Stroke
1 other identifier
interventional
18
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2008
Shorter than P25 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedJune 24, 2016
June 1, 2016
4 months
June 15, 2016
June 21, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
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
Change from baseline at 4 weeks
Study Arms (2)
treadmill training with functional electrical stimulation
EXPERIMENTALSubjects 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.
treadmill training without functional electrical stimulation
ACTIVE COMPARATORSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 24, 2016
Study Start
August 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 24, 2016
Record last verified: 2016-06