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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

Tracking Information
First Submitted Date  ICMJE August 1, 2012
First Posted Date  ICMJE August 7, 2012
Last Update Posted Date August 7, 2012
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thermal Stimulation for Stroke Patients
Official Title  ICMJE 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
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Upper Limb Paresis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 6, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01658293
Other Study ID Numbers  ICMJE IRB100-25
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jia-Ching Chen, Buddhist Tzu Chi General Hospital
Study Sponsor  ICMJE Buddhist Tzu Chi General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jia Ching Chen, master Tzu Chi Buddhist General Hospital, Hualien, Taiwan
PRS Account Buddhist Tzu Chi General Hospital
Verification Date August 2012

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