Neuromuscular Electrical Stimulation Cycling

Not Applicable

• Conditions: Stroke
• Interventions: Device: lower-limb cycling system

• Registration Number: NCT03208439
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2017-08-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

1. 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;
2. severe hip, knee or ankle contracture that would preclude passive range of motion of the leg;
3. implanted cardiac device (e.g. pacemaker and internal defibrillator).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMG-driven NMES	lower-limb cycling system	subjects will receive EMG-driven NMES cycling exercise.
passive pre-programmed NMES	lower-limb cycling system	subjects will receive passive pre-programmed NMES during cycling exercise.

Primary Outcome Measures

Name	Time	Method
Lower-Extremities Fugl-Meyer Assessment	3-month follow up

Secondary Outcome Measures

Name	Time	Method
10-Meter Walk Test	3-month follow up
electroencephalography	3-month follow up
Berg Balance Scale	3-month follow up
Elderly Mobility Scale	3-month follow up
6-Minute Walking Test	3-month follow up

Trial Locations

Locations (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong