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

Kaohsiung Medical University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Stroke

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01078727

KMUH-IRB-950320

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.