BreEStim for Post-Stroke Motor Recovery
ConditionMotor Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center, Houston
About this trial
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 moderate impairment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
BreEStim
DeviceBreEStim will applied for 10 to 20 minutes.
EStim
DeviceEStim will applied for 10 to 20 minutes.
Treatment groups
4 Participants
are divided into 2 treatment groupsGroup A: BreEStimExperimental treatment 1 intervention
Group B: EStimExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 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
Time frame
Baseline, 5 minutes after interventionSecondary outcomes
1
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.
Time frame
Baseline, 5 minutes after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov