Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke

Study Overview
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Brief Summary
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The thermal stimulation have been proven effective in upper extremity of stroke patients. Therefore, this study explored the efficacy of thermal stimulation in lower extremity of stroke patients.

Detailed Description
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There are two groups of stroke patients (onset > 3 months) in this study. The independent factor is temperature of the alternated heat and cold applying.

Official Title
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Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: thermal stimulation


Participation Criteria
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Eligibility Criteria
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The inclusive criteria: first-ever stroke stroke onset > 3 months and < 3 years before the study enrollment unilateral hemiplegia ability to sit on a chair > 30 minutes independently able to follow verbal instructions age between 18 y/o and 80 y/o be willing to participate in this study and gave their informed consent The exclusive criteria: skin disease, skin injuries, burns, or fresh scars over the TS application area contraindication of ice or heat application speech disorder or global aphasia musculoskeletal or cardiac disorders that could potentially interfere diabetic history or sensory impairment attributable to neuropathy.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: noxious thermal stimulation<br>Heat-pain:46-47°C and Cold-pain:2-3°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given | Other: thermal stimulation<br>* hot and cold/warm and cool pads applying.<br>* Other names: Thermal stimulation (FIRSTEK, Model-B401L,local company).;|
| Active Comparator: thermal stimulation (innocuous)<br>Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given | Other: thermal stimulation<br>* hot and cold/warm and cool pads applying.<br>* Other names: Thermal stimulation (FIRSTEK, Model-B401L,local company).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM) | The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement (LE-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up. | pre, post, 1M follow-up | 
| The change score from baseline to post-treatment and baseline to 1M follow-up in the mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) | The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up. | pre, post, 1M follow-up | 
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC) | Functional Ambulation Category (FAC) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up. | pre, post, 1M follow-up | 
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index | Barthel Index (BI) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up. | pre, post, 1M follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS) | Postural Assessment Scale for Stroke Patients (PASS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up. | pre, post, 1M follow-up | 
| The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale | Modified Ashworth Scale (MAS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up. | pre, post, 1M follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thermal stimulation, lower extremity, temperature, efficacy