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

Not Applicable

Not yet recruiting

• Conditions: Motor Recovery

• 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

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