Thermal Stimulation for Stroke Patients (TSSP)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Limb Paresis
• Intervention / Treatment: Behavioral: thermal stimulation; Behavioral: control group ergometer exercises

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hualien City, Taiwan, 970
    • Tzu Chi Buddhist General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment Scale for stroke upper limb recovery	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.	one year
motricity index	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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semmes-Weinstein monofilaments for sensory functions	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.	one year
the modified motor assessment scale	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.	one year
Barthel index	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.	one year

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Principal Investigator: Jia-Ching Chen, master, Tzu Chi Buddhist General Hospital, Hualien, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 7, 2012

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; upper limb; follow up
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: IRB100-25