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

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT01668420
• Lead Sponsor: Hsin-Wen Hsu

Brief Summary

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

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 Timeline

• Study Start: 2009-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-20
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	pre, post, 1M follow-up	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.
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)	pre, post, 1M follow-up	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.
The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)	pre, post, 1M follow-up	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.
The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index	pre, post, 1M follow-up	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.

Secondary Outcome Measures

Name	Time	Method
The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)	pre, post, 1M follow-up	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.
The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale	pre, post, 1M follow-up	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.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan