BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)
Purpose
The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with severe impairment.
Condition
- Motor Recovery
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- has post stroke ≥ 6 months , medically stable; - Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke); - MAS score ≥ 1, i.e., detectable finger flexor hypertonia;
Exclusion Criteria
include: - Patients with visual deficit/neglect; hearing or cognitive impairment; - Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD); - Patients that are currently adjusting tone alternating medications (e.g., baclofen), or - Patients received botulinum toxin injection to the arm/fingers <4 months, or phenol injections < 2 years; - Patients with a pacemaker; - Women who are pregnant.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BreEStim |
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. |
|
|
Experimental EStim |
EStim is transcutaneous electrical nerve stimulation. |
|
Recruiting Locations
The University of Texas Health Science Center
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center, Houston