Tzu Chi Buddhist General Hospital
Hualien City, 970, Taiwan
NCT Number: NCT01658293
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.
Looking for future studies?
Notify Me30 year–80 year
All sexes
Interventional
Not applicable
Hualien City, 970, Taiwan
Stroke patients from department of rehabilitation in Tzu Chi general hospital will be recruited and randomized into two groups, one for experimental group and the other for control group. In addition to receiving routine standard rehabilitation for both groups, the experimental group will receive additional hot- and cold-water stimulation alternatively for five times one session, consecutive four sessions a set, one set for 30 minutes a day and five sets a week for six weeks. The control group will be given ergometer exercises with the similar duration as experimental group. Both groups will be evaluated at baseline before TS and every two weeks till six weeks after TS, then at 3, 6 and 12 months for follow-up. A variety of evaluations used in the present study include Semmes-Weinstein monofilaments for sensory functions; Brunnstrom's stage, Fugl-Meyer Assessment Scale and Motricity Index were used for upper limb motor control and strength; Box and block test for hand dexterity. The modified Motor Assessment Scale and Barthel Index are utilized for evaluating general motor functions and daily activity performance, respectively. The modified Ashworth scale is used for change of muscle tone of upper limb.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: one year
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.
Time frame: one year
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.
Time frame: one year
The investigators selected the Semmes-Weinstein monofilaments for sensory functions as our secondary outcome measures evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.
Time frame: one year
The investigators used the modified motor 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.
Time frame: one year
The investigators used the Barthel 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.
Buddhist Tzu Chi General Hospital
Other
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
Acronym: TSSP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07534124
Brain Diseases, Cardiovascular Diseases
Madrid, Spain
View Trial DetailsNCT04992910
Brain Diseases, Cardiovascular Diseases
Córdoba, Spain
View Trial DetailsNCT01573585
Brain Diseases, Cardiovascular Diseases
North Vancouver, British Columbia, Canada
View Trial DetailsNCT06752499
Brain Diseases, Cardiovascular Diseases
Shanghai, Shanghai Municipality, China
View Trial Details