BreEStim for Post-Stroke Motor Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BreEStim, EStim.
- Who it may be relevant to
- Registry conditions: Motor Recovery. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).
Overview
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.
Interventions
- Device BreEStim
BreEStim will applied for 10 to 20 minutes. - Device EStim
EStim will applied for 10 to 20 minutes.
Primary outcome measures
- Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS) [Time frame: Baseline, 5 minutes after intervention]
Secondary outcome measures (1)
- Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale [Time frame: Baseline, 5 minutes after intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center — Houston
Identifiers
NCT: NCT04750551 · HSC-MS-20-1286 (Experiment 1)