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

Not Applicable

Not yet recruiting

• Conditions: Motor Recovery
• Interventions: Device: EStim; Device: BreEStim

• Registration Number: NCT04750564
• Lead Sponsor: The University of Texas Health Science Center, Houston

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 severe impairment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Study Start: 2025-09-01
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EStim	EStim	EStim is transcutaneous electrical nerve stimulation.
BreEStim	BreEStim	BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Primary Outcome Measures

Name	Time	Method
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)	Baseline, 5 minutes after intervention	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 Outcome Measures

Name	Time	Method
Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale	Baseline, 5 minutes after intervention	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States