Thermal Stimulation for Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-01

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Upper Limb Paresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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thermal stimulation

The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.

Group Type EXPERIMENTAL

thermal stimulation

Intervention Type BEHAVIORAL

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.

control group

The control group receiving the similar intensity of ergometer exercise as the experimental group.

Group Type ACTIVE_COMPARATOR

control group ergometer exercises

Intervention Type BEHAVIORAL

The control group will be given ergometer exercises with the similar duration as experimental group.

Interventions

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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.

Intervention Type BEHAVIORAL

control group ergometer exercises

The control group will be given ergometer exercises with the similar duration as experimental group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No