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Thermal Stimulation for Stroke Patients (TSSP)

This study is currently recruiting participants.
Verified August 2012 by Buddhist Tzu Chi General Hospital
Sponsor:
Information provided by (Responsible Party):
Jia-Ching Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01658293
First received: August 1, 2012
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
Upper Limb Paresis
 Behavioral: thermal stimulation
Behavioral: control group ergometer exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • Fugl-Meyer Assessment Scale for stroke upper limb recovery [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Semmes-Weinstein monofilaments for sensory functions [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: thermal stimulation
The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.
 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.
Active Comparator: control group
The control group receiving the similar intensity of ergometer exercise as the experimental group.
 Behavioral: control group ergometer exercises
The control group will be given ergometer exercises with the similar duration as experimental group.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658293

Contacts
Contact: Jia Ching Chen, master +886-03-8561825 ext 3279 c123010@yahoo.com.tw

Locations
Taiwan
Tzu Chi Buddhist General Hospital Recruiting
Hualien, Taiwan, 970
Contact: Jia Ching Chen, master     +886-03-8561825 ext 3279     c123010@yahoo.com.tw    
Principal Investigator: Jia Ching Chen, master            
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Jia Ching Chen, master Tzu Chi Buddhist General Hospital, Hualien, Taiwan
  More Information

No publications provided

Responsible Party: Jia-Ching Chen, Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01658293     History of Changes
Other Study ID Numbers: IRB100-25
Study First Received: August 1, 2012
Last Updated: August 6, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Buddhist Tzu Chi General Hospital:
stroke
follow up
upper limb
rehabilitation

Additional relevant MeSH terms:
Paresis
Stroke
Cerebral Infarction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 22, 2013