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Treadmill Training With Functional Electric Stimulation After Stroke

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ClinicalTrials.gov Identifier: NCT02812472
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Yea-Ru Yang, National Yang Ming University

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Treadmill training with functional electrical stimulation Other: Treadmill training without functional electrical stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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



Primary Outcome Measures :
  1. N1 latency of somatosensory evoked potential [ Time Frame: Change from baseline at 4 weeks ]
  2. N1P1 amplitude of somatosensory evoked potential [ Time Frame: Change from baseline at 4 weeks ]
  3. motor threshold of motor evoked potential [ Time Frame: Change from baseline at 4 weeks ]
  4. map size of motor evoked potential [ Time Frame: Change from baseline at 4 weeks ]

Secondary Outcome Measures :
  1. Fugl-Meyer Assessment [ Time Frame: Change from baseline at 4 weeks ]
  2. Motricity Index [ Time Frame: Change from baseline at 4 weeks ]
  3. Berg Balance Scale [ Time Frame: Change from baseline at 4 weeks ]
  4. walking speed [ Time Frame: Change from baseline at 4 weeks ]
  5. 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.



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Ages Eligible for Study:   40 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Yea-Ru Yang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT02812472     History of Changes
Other Study ID Numbers: 960053
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases