NCT01078727

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2010-01-01
• First posted: 2010-03-02
• Last updated: 2010-03-02

Locations

1 site across 1 country: Taiwan