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

NCT01078727 | Completed Phase 1

• 1 other identifier: KMUH-IRB-950320
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Thermal Stimulation; Upper Extremity; Motor Recovery; Stroke

Outcome Measures

Primary Outcomes (4)

• Stroke Rehabilitation Assessment of Movement

  3 months

• Action Research Arm Test

  3 months

• Barthel Index

  3 months

• Modified Ashworth Scale

  3 months

Interventions

A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan). DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator
• National Health Research Institutes, Taiwan: collaborator
• National Taiwan University: collaborator
• Kaohsiung Medical University: collaborator

Study Sites (1)

Department of Physical Therapy, Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• J H Lin, PhD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: March 2, 2010
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 2, 2010

Record last verified: 2008-02

Locations

TW (1)