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

Hsin-Wen Hsu34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stroke

Interventions

thermal stimulationOTHER

hot and cold/warm and cool pads applying.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: pre, post, 1M follow-up

Secondary Outcomes

The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)

Data from ClinicalTrials.gov

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