Thermal Stimulation for Stroke Patients

Not Applicable

Completed

• Conditions: Upper Limb Paresis; Stroke
• Interventions: Behavioral: thermal stimulation; Behavioral: control group ergometer exercises

• Registration Number: NCT01658293
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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 Timeline

• Study Start: 2012-08-01
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thermal stimulation	thermal stimulation	The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.
control group	control group ergometer exercises	The control group receiving the similar intensity of ergometer exercise as the experimental group.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment Scale for stroke upper limb recovery	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	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 Outcome Measures

Name	Time	Method
Semmes-Weinstein monofilaments for sensory functions	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	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	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.

Trial Locations

Locations (1)

Tzu Chi Buddhist General Hospital; 🇨🇳 Hualien City, Taiwan