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Clinical Trials/NCT03208439
NCT03208439
Unknown
Not Applicable

Interactive Cycling System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Rehabilitation

Chinese University of Hong Kong1 site in 1 country20 target enrollmentAugust 10, 2017
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Chinese University of Hong Kong
Enrollment
20
Locations
1
Primary Endpoint
Lower-Extremities Fugl-Meyer Assessment
Last Updated
8 years ago

Overview

Brief Summary

A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.

Registry
clinicaltrials.gov
Start Date
August 10, 2017
End Date
January 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raymond KY Tong

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke;
  • sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
  • significant gait deficit (Functional Ambulatory Category, FAC, scale \<4 \[person cannot walk independently\]).

Exclusion Criteria

  • any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression;
  • severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
  • implanted cardiac device (e.g. pacemaker and internal defibrillator).

Outcomes

Primary Outcomes

Lower-Extremities Fugl-Meyer Assessment

Time Frame: 3-month follow up

Secondary Outcomes

  • Berg Balance Scale(3-month follow up)
  • electroencephalography(3-month follow up)
  • 10-Meter Walk Test(3-month follow up)
  • Elderly Mobility Scale(3-month follow up)
  • 6-Minute Walking Test(3-month follow up)

Study Sites (1)

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