Motor Recovery Clinical Trial
Official title:
BreEStim for Post-Stroke Motor Recovery
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.
Status | Not yet recruiting |
Enrollment | 4 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 include: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 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) More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension |
Baseline, 5 minutes after intervention | |
Secondary | 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. |
Baseline, 5 minutes after intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04570774 -
Effect of Cerebral and Cerebellar rTMS in Stroke Patient
|
N/A | |
Not yet recruiting |
NCT04752319 -
BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment After a Long-term Use (Pilot).
|
N/A | |
Not yet recruiting |
NCT06029062 -
tACS for Sensory Motor Recovery After Stroke
|
N/A | |
Not yet recruiting |
NCT04750551 -
BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).
|
N/A | |
Not yet recruiting |
NCT06121947 -
Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia
|
N/A | |
Recruiting |
NCT04830631 -
tDCS Response Prediction Using EEG in Stroke
|
||
Recruiting |
NCT04074018 -
Impacts of Two Rehabilitation Programs on Chronic Peripheral Facial Paresis
|
N/A |