Neuromuscular Electrical Stimulation Cycling

The Chinese University of Hong Kong

Status: Unknown

Conditions: Stroke

Treatments: Device: lower-limb cycling system

Study type: Interventional

Funder types: Other

Identifiers

NCT03208439

2016.093-T

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

EMG-driven NMES

Experimental group

Description:

subjects will receive EMG-driven NMES cycling exercise.

Treatment:

Device: lower-limb cycling system

passive pre-programmed NMES

Placebo Comparator group

Description:

subjects will receive passive pre-programmed NMES during cycling exercise.

Treatment:

Device: lower-limb cycling system