Stroke
Conditions
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.
Interventions
DEVICElower-limb cycling system
patients will receive 30-minute cycling exercise
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower-Extremities Fugl-Meyer Assessment | 3-month follow up |
Secondary
| Measure | Time frame |
|---|---|
| Elderly Mobility Scale | 3-month follow up |
| Berg Balance Scale | 3-month follow up |
| 6-Minute Walking Test | 3-month follow up |
| 10-Meter Walk Test | 3-month follow up |
| electroencephalography | 3-month follow up |
Countries
Hong Kong
Contacts
Primary ContactRaymond Kai-yu Tong, PhD
Outcome results
None listed