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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668420
• Other study ID #: KMUH-IRB-980332
• Status: Completed
• Phase: N/A
• First received: August 12, 2012
• Last updated: November 7, 2012
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2012
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• thermal stimulation
hot and cold/warm and cool pads applying.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City

Sponsors (2)

Lead Sponsor	Collaborator
Hsin-Wen Hsu	Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No