Clinical trial NCT01418404: The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
Official title: The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Effects of TS in U/E motor recovery
Brain mapping
Kinematics analysis
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: E-DA Hospital
name: Kaohsiung Municipal Hsiaokang Hospital
First posted: 2011-08-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In literature review, thermal stimulation (TS) intervention is effective in facilitating upper extremity functional recovery in stroke patients. In addition, several functional MRI studies have indicated that thermal stimuli promoted activation in the premotor and motor cortices of healthy participants. These imply the possibility of TS in cortical reorganization. However, there were no studies exploring the relationship of the TS intervention and cortical reorganization. By the functional recovery of stroke patients, findings of brain image and brain mapping, it could enhance the understanding the TS influences on brain reorganization. Regarding with clinical application of the TS intervention for improving functional performance of upper extremity in participants with stroke, the best parameters of TS intervention in clinical practice have not been decided. Therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute, chronic) undergoing TS intervention with different parameters. Functional scales, kinematic data, brain image were taken in several timelines as outcome measures.

Detailed description: The thermal stimulation (TS) intervention uses the heat and cold apply alternately (\~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. Moreover, some studies have proved efficacy of the TS on stroke. However, the best parameters and application on different-stage stroke groups have not been clearly explored. Moreover, in order to discover the TS intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group A (explained in the below). In addition, the kinematic data was also collected in group A. However, the above-mentioned three examination are optional. Finally, functional recovery measurements (clinical scales) are measured in the three groups.

There are three groups (90 participants in each group) and their respective TS intervention design. In other word, three sub-studies (A, B, C) are under this project. Group A recruited 90 acute stroke (\~ 30 days) and the independent variable is temperature of TS intervention. Group B is with sub-acute stroke (3-12 months), undergoing different frequency of TS intervention. Group C targets on participants with chronic stroke (\> 1 y/o) and this variation in TS is intensity of TS application (30 mins vs 60 mins/each session).

Eligibility criteria: Inclusion Criteria:

1. first-ever ischemic stroke;
2. no severe cognitive impairments and able to follow instructions;
3. sit on a chair for more than 30 minutes independently.

Exclusion Criteria:

1. musculoskeletal or cardiac disorders that potentially interferes with experimental tests;
2. diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy;
3. speech disorder or global aphasia;
4. skin problems at the sites of stimulation;

6.contraindications of heat or ice application.

Primary outcomes:
measure: Movement performance assessment
timeFrame: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
measure: Brain images
timeFrame: immediate effects in 3 timeline
measure: Mapping of brain cortex
timeFrame: immediate effect in four timeline
measure: Kinematics measure of upper extremity movement
timeFrame: four timeline
Secondary outcomes:
measure: Quality of life
timeFrame: baseline, post-intervention, 6 month follow-up
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Jau-Hong Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen SC, Hsu MJ, Kuo YT, Lin RT, Lo SK, Lin JH. Immediate effects of noxious and innocuous thermal stimulation on brain activation in patients with stroke. Medicine (Baltimore). 2020 Feb;99(9):e19386. doi: 10.1097/MD.0000000000019386.