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Neuromuscular Electrical Stimulation Cycling

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ClinicalTrials.gov Identifier: NCT03208439
Recruitment Status : Unknown
Verified September 2017 by Raymond KY Tong, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : July 5, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Raymond KY Tong, 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.

Condition or disease Intervention/treatment Phase
Stroke Device: lower-limb cycling system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interactive Cycling System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Rehabilitation
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2018

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




Primary Outcome Measures :
  1. Lower-Extremities Fugl-Meyer Assessment [ Time Frame: 3-month follow up ]

Secondary Outcome Measures :
  1. Elderly Mobility Scale [ Time Frame: 3-month follow up ]
  2. Berg Balance Scale [ Time Frame: 3-month follow up ]
  3. 6-Minute Walking Test [ Time Frame: 3-month follow up ]
  4. 10-Meter Walk Test [ Time Frame: 3-month follow up ]
  5. electroencephalography [ Time Frame: 3-month follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208439


Contacts
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Contact: Raymond Kai-yu Tong, PhD +852 3943 8454 kytong@cuhk.edu.hk

Locations
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Hong Kong
Department of Biomedical Engineering, The Chinese University of Hong Kong Recruiting
Shatin, Hong Kong
Contact: Raymond Tong, PhD    +852 3943 8454      
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Raymond Kai-yu Tong, PhD Department of Biomedical Engineering, CUHK
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Responsible Party: Raymond KY Tong, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03208439    
Other Study ID Numbers: 2016.093-T
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No