Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
This study has been completed.
Sponsor:
Hsin-Wen Hsu
Collaborator:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by (Responsible Party):
Hsin-Wen Hsu, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01668420
First received: August 12, 2012
Last updated: November 7, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke |
Other: thermal stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke |
Resource links provided by NLM:
Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Primary Outcome Measures:
- 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) [ Time Frame: pre, post, 1M follow-up ] [ Designated as safety issue: No ]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) [ Time Frame: pre, post, 1M follow-up ] [ Designated as safety issue: No ]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) [ Time Frame: pre, post, 1M follow-up ] [ Designated as safety issue: No ]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 [ Time Frame: pre, post, 1M follow-up ] [ Designated as safety issue: No ]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:
- The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS) [ Time Frame: pre, post, 1M follow-up ] [ Designated as safety issue: No ]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 [ Time Frame: pre, post, 1M follow-up ] [ Designated as safety issue: No ]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.
| Enrollment: | 34 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: noxious thermal stimulation
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
hot and cold/warm and cool pads applying.
Other Name: Thermal stimulation (FIRSTEK, Model-B401L,local company).
|
|
Active Comparator: thermal stimulation (innocuous)
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
hot and cold/warm and cool pads applying.
Other Name: Thermal stimulation (FIRSTEK, Model-B401L,local company).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668420
Locations
| Taiwan | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | |
| Kaohsiung City, Taiwan, 807 | |
Sponsors and Collaborators
Hsin-Wen Hsu
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
| Principal Investigator: | Hsin-Wen Hsin, graduated | Kaohsiung Medical University Chung-Ho Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Hsin-Wen Hsu, physical therapist (graduated student), Kaohsiung Medical University Chung-Ho Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01668420 History of Changes |
| Other Study ID Numbers: | KMUH-IRB-980332 |
| Study First Received: | August 12, 2012 |
| Last Updated: | November 7, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
|
thermal stimulation lower extremity temperature efficacy |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013