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Completed

NCT Number: NCT02812472

Treadmill Training With Functional Electric Stimulation After 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.

Completed

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill training with functional electrical stimulation

Other

Treadmill training without functional electrical stimulation

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 24, 2016
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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