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

Stroke Clinical Trial

Official title:

Thermal Stimulation on Upper Extremity Movement and Function in Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078727
• Other study ID #: KMUH-IRB-950320
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 11, 2010
• Last updated: March 1, 2010
• Start date: August 2007
• Est. completion date: January 2010

Study information

• Verified date: February 2008
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy, Kaohsiung Medical University	Kaohsiung

Sponsors (5)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung Medical University, National Health Research Institutes, Taiwan, National Science Council, Taiwan, National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Rehabilitation Assessment of Movement		3 months	No
Primary	Action Research Arm Test		3 months	No
Primary	Barthel Index		3 months	No
Primary	Modified Ashworth Scale		3 months	No