BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)

Study Overview
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Brief Summary
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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.

Official Title
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BreEStim for Post-Stroke Motor Recovery

Conditions
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Motor Recovery

Intervention / Treatment
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* Device: BreEStim
* Device: EStim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BreEStim<br>BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. | Device: BreEStim<br>* BreEStim will applied for 10 to 20 minutes.<br>|
| Experimental: EStim<br>EStim is transcutaneous electrical nerve stimulation. | Device: EStim<br>* EStim will applied for 10 to 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS) | 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 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) More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension | Baseline, 5 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale | 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. | Baseline, 5 minutes after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Finger flexor spasticity, Motor Recovery, BreEStim