Thermal Stimulation for Stroke Patients
TSSP
Facilitation of Sensory and Motor Recovery by Means of Heat and Cold-water Stimulation on the Paretic Upper Limb of After Stroke: One Year Follow up
1 other identifier
interventional
60
1 country
1
Brief Summary
Sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. Thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. However, whether hot- and cold-water stimulation alternatively based on thermal stimulation also has the effect still remains unknown. The aim of present study is to investigate the facilitated effect of hot and cold water stimulation alternatively on upper limb after stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Aug 2012
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2014
CompletedJanuary 26, 2022
January 1, 2022
2.4 years
August 1, 2012
January 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fugl-Meyer Assessment Scale for stroke upper limb recovery
The investigators will use the Fugl-Meyer Assessment Scale as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
one year
motricity index
The investigators will use the motricity index as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
one year
Secondary Outcomes (3)
Semmes-Weinstein monofilaments for sensory functions
one year
the modified motor assessment scale
one year
Barthel index
one year
Study Arms (2)
thermal stimulation
EXPERIMENTALThe experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.
control group
ACTIVE COMPARATORThe control group receiving the similar intensity of ergometer exercise as the experimental group.
Interventions
The heat and cold-water will be added to the thermal group for 30-40minutes a session daily,five sessions a week for six weeks.
The control group will be given ergometer exercises with the similar duration as experimental group.
Eligibility Criteria
You may qualify if:
- a first-time ischemic or hemorrhagic stroke.
- no severe diabetes or peripheral vascular disease causing sensory deficits.
- no cognition problem and follow directions indicated by therapist during experiment.
- motor deficit of the upper limb under (including) Brunnstrom stage IV, either in the arm or hand.
You may not qualify if:
- a cardiac disease or orthopedic problem history,
- medically unstable such as experienced unstable angina, uncontrolled hypertension according to the treating physician, psychological history before stroke.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tzu Chi Buddhist General Hospital
Hualien City, 970, Taiwan
Related Publications (1)
Chiu YT, Liang CC, Yu Cheng H, Lin CH, Chen JC. Alternating Hot-Cold Water Immersion Facilitates Motor Function Recovery in the Paretic Upper Limb After Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Sep;105(9):1642-1648. doi: 10.1016/j.apmr.2024.05.008. Epub 2024 May 10.
PMID: 38734047DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jia-Ching Chen, master
Tzu Chi Buddhist General Hospital, Hualien, Taiwan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Rehabilitation Medicine
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 7, 2012
Study Start
August 1, 2012
Primary Completion
December 31, 2014
Study Completion
December 31, 2014
Last Updated
January 26, 2022
Record last verified: 2022-01