Skip to main content
OpenTrials
Completed

NCT Number: NCT01078727

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Physical Therapy, Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Stroke Rehabilitation Assessment of Movement

    Time frame: 3 months

  2. Action Research Arm Test

    Time frame: 3 months

  3. Barthel Index

    Time frame: 3 months

  4. Modified Ashworth Scale

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Kaohsiung Medical University
  • National Health Research Institutes, Taiwan
  • National Science and Technology Council, Taiwan
  • National Taiwan University

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 2, 2010
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.