Clinical trial NCT01078727: Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke
Official title: Thermal Stimulation on Upper Extremity Movement and Function in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: Thermal Stimulation
Upper Extremity
Motor Recovery
Stroke
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
name: National Taiwan University
name: Kaohsiung Medical University
First posted: 2010-03-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. first-ever stroke survivors with unilateral hemispheric lesions from a hemorrhagic or nonhemorrhagic stroke;
2. stroke onset more than 3 months and less than 3 years prior to study enrollment;
3. no severe cognitive impairments and able to follow instructions;
4. the ability to sit on a chair for more than 30 minutes independently.

Exclusion Criteria:

1. musculoskeletal or cardiac disorders that could potentially interfere with experimental tests;
2. diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy;
3. speech disorder or global aphasia;
4. participating in any experimental rehabilitation or drug studies;
5. skin injuries, burns, or fresh scars at the sites of stimulation;
6. contraindication of heat or ice application.

Primary outcomes:
measure: Stroke Rehabilitation Assessment of Movement
timeFrame: 3 months
measure: Action Research Arm Test
timeFrame: 3 months
measure: Barthel Index
timeFrame: 3 months
measure: Modified Ashworth Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Physical Therapy, Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: J H Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: