Back to resultsEffect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
thermal stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring thermal stimulation, lower extremity, temperature, efficacy
Eligibility 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.
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
noxious thermal stimulation
thermal stimulation (innocuous)
Arm Description
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
Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given
Outcomes
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)
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)
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)
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
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)
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
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.
Full Information
NCT ID
NCT01668420
First Posted
August 12, 2012
Last Updated
November 7, 2012
Sponsor
Hsin-Wen Hsu
Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01668420
Brief Title
Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Official Title
Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hsin-Wen Hsu
Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
thermal stimulation, lower extremity, temperature, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
noxious thermal stimulation
Arm Type
Experimental
Arm Description
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
Arm Title
thermal stimulation (innocuous)
Arm Type
Active Comparator
Arm Description
Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given
Intervention Type
Other
Intervention Name(s)
thermal stimulation
Other Intervention Name(s)
Thermal stimulation (FIRSTEK, Model-B401L,local company).
Intervention Description
hot and cold/warm and cool pads applying.
Primary Outcome Measure Information:
Title
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)
Description
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
Title
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)
Description
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
Title
The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)
Description
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
Title
The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index
Description
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 Outcome Measure Information:
Title
The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)
Description
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.
Time Frame
pre, post, 1M follow-up
Title
The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale
Description
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.
Time Frame
pre, post, 1M follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin-Wen Hsin, graduated
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
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