- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418404
The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
Study Overview
Status
Conditions
Detailed Description
The thermal stimulation (TS) intervention uses the heat and cold apply alternately (~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.
There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kaohsiung city, Taiwan, 807
- Kaohsiung Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- first-ever ischemic stroke;
- no severe cognitive impairments and able to follow instructions;
- sit on a chair for more than 30 minutes independently.
Exclusion Criteria:
- musculoskeletal or cardiac disorders that potentially interferes with experimental tests;
- diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;
- speech disorder or global aphasia;
- skin problems at the sites of stimulation;
6.contraindications of heat or ice application.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Noxious TS in study A
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hot, cold alternately, noxious TS in study A
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Active Comparator: Innocuous TS
Innocuous TS in study A
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warm, cool alternately, Innocuious TS in study A
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Experimental: High Frequency of Noxious TS
High Frequency of Noxious TS in study B
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High Frequency of Noxious TS in study B
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Active Comparator: Low Frequency of Noxious TS
Low Frequency of Noxious TS in study B
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Low Frequency of Noxious TS in study B
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Experimental: High Intensity of Noxious TS
High Intensity of Noxious TS in study C
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High Intensity of Noxious TS in study C
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Active Comparator: Low Intensity of Noxious TS
Low Intensity of Noxious TS in study C
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Low Intensity of Noxious TS in study C
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement performance assessment
Time Frame: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
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baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
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Brain images
Time Frame: immediate effects in 3 timeline
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immediate effects in 3 timeline
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Mapping of brain cortex
Time Frame: immediate effect in four timeline
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immediate effect in four timeline
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Kinematics measure of upper extremity movement
Time Frame: four timeline
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four timeline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: baseline, post-intervention, 6 month follow-up
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baseline, post-intervention, 6 month follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Jau-Hong Lin, Professor, Kaohsiung Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHRI-EX99-9907PI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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