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

Completed

Phase 1/2 Results N/A

Trial Description

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

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure 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

Sponsors