Skip to main content
Clinical Trials/NCT01658293
NCT01658293
Completed
N/A

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

Buddhist Tzu Chi General Hospital1 site in 1 country60 target enrollmentAugust 1, 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Buddhist Tzu Chi General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Fugl-Meyer Assessment Scale for stroke upper limb recovery
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2012
End Date
December 31, 2014
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Buddhist Tzu Chi General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jia-Ching Chen

Department of Rehabilitation Medicine

Buddhist Tzu Chi General Hospital

Eligibility 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Semmes-Weinstein monofilaments for sensory functions(one year)
  • the modified motor assessment scale(one year)
  • Barthel index(one year)

Study Sites (1)

Loading locations...

Similar Trials