Motor Recovery
Conditions
Keywords
Finger flexor spasticity, Motor Recovery, BreEStim
Brief summary
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 moderate impairment after a long-term use.
Interventions
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS) | Baseline, after 10 intervention sessions, about 3 weeks | MAS will be performed to check changes of finger flexor spasticity after one session of treatment. The Modified Ashworth scale (MAS) scoring is categorical and ranges from 0 to 4, as follows: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM) 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale | Baseline, after 10 intervention sessions, about 3 weeks | FMA will be assessed to test function changes of finger extensors and hand function after one session of treatment. The upper limb motor function domain of the FMA scale will be used, and the score range for this domain is 0 to 66, with a higher score indicating better function. |
Countries
United States
Contacts
Primary ContactSheng Li, MD, PhD
Backup ContactShengai Li, MS
Outcome results
None listed