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Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Thermal Stimulation, Upper Extremity, Motor Recovery, Stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. first-ever stroke survivors with unilateral hemispheric lesions from a hemorrhagic or nonhemorrhagic stroke;
  2. stroke onset more than 3 months and less than 3 years prior to study enrollment;
  3. no severe cognitive impairments and able to follow instructions;
  4. the ability to sit on a chair for more than 30 minutes independently.

Exclusion Criteria:

  1. musculoskeletal or cardiac disorders that could potentially interfere with experimental tests;
  2. diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy;
  3. speech disorder or global aphasia;
  4. participating in any experimental rehabilitation or drug studies;
  5. skin injuries, burns, or fresh scars at the sites of stimulation;
  6. contraindication of heat or ice application.

Sites / Locations

  • Department of Physical Therapy, Kaohsiung Medical University

Outcomes

Primary Outcome Measures

Stroke Rehabilitation Assessment of Movement
Action Research Arm Test
Barthel Index
Modified Ashworth Scale

Secondary Outcome Measures

Full Information

First Posted
February 11, 2010
Last Updated
March 1, 2010
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan, National Taiwan University, Kaohsiung Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01078727
Brief Title
Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke
Official Title
Thermal Stimulation on Upper Extremity Movement and Function in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
National Science Council, Taiwan, National Health Research Institutes, Taiwan, National Taiwan University, Kaohsiung Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Improving upper extremity movement and function in patients with stroke has been one of the primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had been first found by a domestic research group to be effective to facilitate sensory and motor recovery in patients with stroke within a month. However, the immediate and long-term effects of TS and the mechanism of brain plasticity in patients with stroke for more than three months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized controlled trial to investigate the immediate and long-term effects of TS in patients with stroke at subacute and chronic stages.
Detailed Description
The study was an assessor-blinded randomized controlled clinical trial. Participants with UE impairment for more than 3 months poststroke were randomly assigned to either the experimental (EXP) group or the control group. All participants received regular conventional rehabilitation programs. The EXP group received an additional UE-TS protocol for 30 minutes a day (3 days/week for 8 weeks); the control group received the same TS protocol over the lower extremity (LE). The Brunnstrom's recovery stage, the Modified Ashworth Scale (MAS), the Stroke Rehabilitation Assessment of Movement (STREAM), the Action Research Arm Test (ARAT), and the Barthel Index (BI) were outcome measures and were administered at baseline, 4 weeks and 8 weeks post inception, and at one-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Thermal Stimulation, Upper Extremity, Motor Recovery, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).
Intervention Description
The subjects meeting our criteria will be randomly assigned to either the experimental group or the control group. First stage (3 months after onset), the subjects in the experimental group will receive an upper extremity Thermal Stimulation (TS) protocol for 30 minutes (3 times a week for 8 weeks). The subjects in the control group will receive a lower extremity TS protocol.
Primary Outcome Measure Information:
Title
Stroke Rehabilitation Assessment of Movement
Time Frame
3 months
Title
Action Research Arm Test
Time Frame
3 months
Title
Barthel Index
Time Frame
3 months
Title
Modified Ashworth Scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first-ever stroke survivors with unilateral hemispheric lesions from a hemorrhagic or nonhemorrhagic stroke; stroke onset more than 3 months and less than 3 years prior to study enrollment; no severe cognitive impairments and able to follow instructions; the ability to sit on a chair for more than 30 minutes independently. Exclusion Criteria: musculoskeletal or cardiac disorders that could potentially interfere with experimental tests; diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy; speech disorder or global aphasia; participating in any experimental rehabilitation or drug studies; skin injuries, burns, or fresh scars at the sites of stimulation; contraindication of heat or ice application.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J H Lin, PhD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

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Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke

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