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Thermal Stimulation for Stroke Patients (TSSP)

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ClinicalTrials.gov Identifier: NCT01658293
Recruitment Status : Unknown
Verified August 2012 by Jia-Ching Chen, Buddhist Tzu Chi General Hospital.
Recruitment status was:  Recruiting
First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Jia-Ching Chen, Buddhist Tzu Chi General Hospital

August 1, 2012
August 7, 2012
August 7, 2012
July 2011
December 2014   (Final data collection date for primary outcome measure)
  • Fugl-Meyer Assessment Scale for stroke upper limb recovery [ 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.
  • motricity index [ 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.
Same as current
No Changes Posted
  • Semmes-Weinstein monofilaments for sensory functions [ 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.
  • the modified motor assessment scale [ 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.
  • Barthel index [ 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.
Same as current
Not Provided
Not Provided
 
Thermal Stimulation for Stroke Patients
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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Upper Limb Paresis
  • Behavioral: thermal stimulation
    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.
  • Behavioral: control group ergometer exercises
    The control group will be given ergometer exercises with the similar duration as experimental group.
  • Experimental: thermal stimulation
    The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.
    Intervention: Behavioral: thermal stimulation
  • Active Comparator: control group
    The control group receiving the similar intensity of ergometer exercise as the experimental group.
    Intervention: Behavioral: control group ergometer exercises
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01658293
IRB100-25
Yes
Not Provided
Not Provided
Jia-Ching Chen, Buddhist Tzu Chi General Hospital
Buddhist Tzu Chi General Hospital
Not Provided
Principal Investigator: Jia Ching Chen, master Tzu Chi Buddhist General Hospital, Hualien, Taiwan
Buddhist Tzu Chi General Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP