Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke

Study Overview
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Brief Summary
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Improving upper extremity movement and function in patients with stroke has been one of the primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had been first found by a domestic research group to be effective to facilitate sensory and motor recovery in patients with stroke within a month. However, the immediate and long-term effects of TS and the mechanism of brain plasticity in patients with stroke for more than three months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized controlled trial to investigate the immediate and long-term effects of TS in patients with stroke at subacute and chronic stages.

Detailed Description
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The study was an assessor-blinded randomized controlled clinical trial. Participants with UE impairment for more than 3 months poststroke were randomly assigned to either the experimental (EXP) group or the control group. All participants received regular conventional rehabilitation programs. The EXP group received an additional UE-TS protocol for 30 minutes a day (3 days/week for 8 weeks); the control group received the same TS protocol over the lower extremity (LE). The Brunnstrom's recovery stage, the Modified Ashworth Scale (MAS), the Stroke Rehabilitation Assessment of Movement (STREAM), the Action Research Arm Test (ARAT), and the Barthel Index (BI) were outcome measures and were administered at baseline, 4 weeks and 8 weeks post inception, and at one-month follow-up.

Official Title
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Thermal Stimulation on Upper Extremity Movement and Function in Patients With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first-ever stroke survivors with unilateral hemispheric lesions from a hemorrhagic or nonhemorrhagic stroke; stroke onset more than 3 months and less than 3 years prior to study enrollment; no severe cognitive impairments and able to follow instructions; the ability to sit on a chair for more than 30 minutes independently. Exclusion Criteria: musculoskeletal or cardiac disorders that could potentially interfere with experimental tests; diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy; speech disorder or global aphasia; participating in any experimental rehabilitation or drug studies; skin injuries, burns, or fresh scars at the sites of stimulation; contraindication of heat or ice application.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).|The subjects meeting our criteria will be randomly assigned to either the experimental group or the control group. First stage (3 months after onset), the subjects in the experimental group will receive an upper extremity Thermal Stimulation (TS) protocol for 30 minutes (3 times a week for 8 weeks). The subjects in the control group will receive a lower extremity TS protocol.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Rehabilitation Assessment of Movement |  | 3 months | 
| Action Research Arm Test |  | 3 months | 
| Barthel Index |  | 3 months | 
| Modified Ashworth Scale |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thermal Stimulation, Upper Extremity, Motor Recovery, Stroke