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Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery

ConditionsStrokeStroke, AcuteStroke, IschemicStroke, HemorrhagicHemiparesisHemiparesis;Poststroke/CVAWeakness of Extremities as Sequela of StrokeStroke SequelaeUpper Extremity Paresis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorAhmed A. Rahim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;

Presentation of hemiparesis or paralysis of the upper extremity due to stroke;

Ability to comprehend and follow study instructions;

Ability to initiate finger extension (≥3°) at least three times per minute;

Disqualifiers

Contraindications, intolerance, or high sensitivity to the experimental protocol;

History of upper-extremity disability prior to the index stroke;

Neurological conditions (other than stroke) affecting motor function;

Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Associative Peripheral Stimulation (APS) 1.0

    Device

    Associative peripheral stimulation paired with rehabilitative exercises.

  • Peripheral Neuromuscular Stimulation

    Device

    Random peripheral stimulation paired with rehabilitative exercises.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Average of Range of Motion (ROM)

Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.

Time frame
5 weeks
2

Fugl-Meyer Assessment Upper-Extremity (FMA-UE)

Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.

Time frame
5 weeks

Secondary outcomes

1

Maximum Average of Range of Motion (ROM)

Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.

Time frame
3 months
2

Fugl-Meyer Assessment Upper-Extremity (FMA-UE)

Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.

Time frame
3 months
3

Action Research Arm Test (ARAT)

Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.

Time frame
5 weeks
4

Action Research Arm Test (ARAT)

Measure of four functional domains: grasp, grip, pinch, and gross arm movement. Scoring Range: 0 to 57. Higher scores indicate better outcomes.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ahmed A. Rahim

Lead sponsor

APS Trial Group

Sponsor institution

Source ClinicalTrials.gov
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