Neuromuscular Electrical Stimulation Cycling

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03208439
• Other study ID #: 2016.093-T
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2017
• Last updated: September 15, 2017
• Start date: August 10, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: September 2017
• Source: Chinese University of Hong Kong
• Contact: Raymond Kai-yu Tong, PhD
• Phone: +852 3943 8454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• lower-limb cycling system
patients will receive 30-minute cycling exercise

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower-Extremities Fugl-Meyer Assessment		3-month follow up
Secondary	Elderly Mobility Scale		3-month follow up
Secondary	Berg Balance Scale		3-month follow up
Secondary	6-Minute Walking Test		3-month follow up
Secondary	10-Meter Walk Test		3-month follow up
Secondary	electroencephalography		3-month follow up