Neuromuscular Electrical Stimulation Cycling

September 15, 2017 updated by: Raymond KY Tong, Chinese University of Hong Kong

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Recruiting
        • Department of Biomedical Engineering, The Chinese University of Hong Kong
        • Contact:
          • Raymond Tong, PhD
          • Phone Number: +852 3943 8454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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]).

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMG-driven NMES
subjects will receive EMG-driven NMES cycling exercise.
Device: lower-limb cycling system
patients will receive 30-minute cycling exercise
Placebo Comparator: passive pre-programmed NMES
subjects will receive passive pre-programmed NMES during cycling exercise.
Device: lower-limb cycling system
patients will receive 30-minute cycling exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower-Extremities Fugl-Meyer Assessment
Time Frame: 3-month follow up
3-month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Elderly Mobility Scale
Time Frame: 3-month follow up
3-month follow up
Berg Balance Scale
Time Frame: 3-month follow up
3-month follow up
6-Minute Walking Test
Time Frame: 3-month follow up
3-month follow up
10-Meter Walk Test
Time Frame: 3-month follow up
3-month follow up
electroencephalography
Time Frame: 3-month follow up
3-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Raymond Kai-yu Tong, PhD, Department of Biomedical Engineering, CUHK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2016.093-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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