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

This study has been completed.
Sponsor:
Collaborators:
National Science Council, Taiwan
National Health Research Institutes, Taiwan
National Taiwan University
Kaohsiung Medical University
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01078727
First received: February 11, 2010
Last updated: March 1, 2010
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Stroke
Device: A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thermal Stimulation on Upper Extremity Movement and Function in Patients With Stroke

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • Stroke Rehabilitation Assessment of Movement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Action Research Arm Test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2007
Study Completion Date: January 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078727

Locations
Taiwan
Department of Physical Therapy, Kaohsiung Medical University
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
National Science Council, Taiwan
National Health Research Institutes, Taiwan
National Taiwan University
Kaohsiung Medical University
Investigators
Principal Investigator: J H Lin, PhD Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: Jau-Hong Lin/Professor, Kaohsiung Medical University
ClinicalTrials.gov Identifier: NCT01078727     History of Changes
Other Study ID Numbers: KMUH-IRB-950320
Study First Received: February 11, 2010
Last Updated: March 1, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Thermal Stimulation
Upper Extremity
Motor Recovery
Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014