Hemiparesis, Hemiparesis;Poststroke/CVA, Stroke, Stroke, Acute, Stroke, Hemorrhagic, Stroke, Ischemic, Stroke Sequelae, Upper Extremity Paresis, Weakness of Extremities as Sequela of Stroke
Conditions
Keywords
Stroke Rehabilitation, Associative Peripheral Stimulation
Brief summary
Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.
Interventions
DEVICEAssociative Peripheral Stimulation (APS) 1.0
Associative peripheral stimulation paired with rehabilitative exercises.
DEVICEPeripheral Neuromuscular Stimulation
Random peripheral stimulation paired with rehabilitative exercises.
Sponsors
Ahmed A. Rahim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment; 2. Presentation of hemiparesis or paralysis of the upper extremity due to stroke; 3. Ability to comprehend and follow study instructions; 4. Ability to initiate finger extension (≥3°) at least three times per minute; 5. Fugl-Meyer Assessment (Upper Extremity) score of \<47.
Exclusion criteria
1. Contraindications, intolerance, or high sensitivity to the experimental protocol; 2. History of upper-extremity disability prior to the index stroke; 3. Neurological conditions (other than stroke) affecting motor function; 4. Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection); 5. Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Average of Range of Motion (ROM) | 5 weeks | Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes. |
| Fugl-Meyer Assessment Upper-Extremity (FMA-UE) | 5 weeks | Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Average of Range of Motion (ROM) | 3 months | Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes. |
| Fugl-Meyer Assessment Upper-Extremity (FMA-UE) | 3 months | Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes. |
| Action Research Arm Test (ARAT) | 5 weeks | Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes. |
Countries
Mexico
Contacts
Primary ContactAhmed A Rahim, MTM
Outcome results
None listed