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Thermal Stimulation for Stroke Patients (TSSP)

Primary Purpose

Stroke, Upper Limb Paresis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
thermal stimulation
control group ergometer exercises
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, follow up, upper limb, rehabilitation

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tzu Chi Buddhist General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

thermal stimulation

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 1, 2012
Last Updated
January 25, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01658293
Brief Title
Thermal Stimulation for Stroke Patients
Acronym
TSSP
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Limb Paresis
Keywords
stroke, follow up, upper limb, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thermal stimulation
Arm Type
Experimental
Arm Description
The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control group receiving the similar intensity of ergometer exercise as the experimental group.
Intervention Type
Behavioral
Intervention Name(s)
thermal stimulation
Intervention Description
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
Intervention Name(s)
control group ergometer exercises
Intervention Description
The control group will be given ergometer exercises with the similar duration as experimental group.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Scale for stroke upper limb recovery
Description
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.
Time Frame
one year
Title
motricity index
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Semmes-Weinstein monofilaments for sensory functions
Description
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.
Time Frame
one year
Title
the modified motor assessment scale
Description
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.
Time Frame
one year
Title
Barthel index
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Ching Chen, master
Organizational Affiliation
Tzu Chi Buddhist General Hospital, Hualien, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tzu Chi Buddhist General Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan

12. IPD Sharing Statement

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Thermal Stimulation for Stroke Patients

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