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Clinical Trials/NCT04750564
NCT04750564
Not yet recruiting
Not Applicable

BreEStim for Post-Stroke Motor Recovery

The University of Texas Health Science Center, Houston1 site in 1 country4 target enrollmentSeptember 1, 2025
ConditionsMotor Recovery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Motor Recovery
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
4
Locations
1
Primary Endpoint
Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sheng Li

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)

Time Frame: 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 Outcomes

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

Study Sites (1)

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