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

NCT ID: NCT01078727

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-01-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

National Taiwan University

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kaohsiung Medical University

Principal Investigators

J H Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Department of Physical Therapy, Kaohsiung Medical University

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUH-IRB-950320

Identifier Type: -

Identifier Source: org_study_id