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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-31

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.

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Detailed Description

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Conditions

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Motor Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BreEStim

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Group Type EXPERIMENTAL

BreEStim

Intervention Type DEVICE

BreEStim will applied for 10 to 20 minutes.

EStim

EStim is transcutaneous electrical nerve stimulation.

Group Type EXPERIMENTAL

EStim

Intervention Type DEVICE

EStim will applied for 10 to 20 minutes.

Interventions

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BreEStim

BreEStim will applied for 10 to 20 minutes.

Intervention Type DEVICE

EStim

EStim will applied for 10 to 20 minutes.

Intervention Type DEVICE

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No