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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
hot, cold alternately, noxious TS in study A
warm, cool alternately, Innocuious TS in study A
High Frequency of Noxious TS in study B
Low Frequency of Noxious TS in study B
High Intensity of Noxious TS in study C
Low Intensity of Noxious TS in study C
Kaohsiung Medical University
Kaohsiung City, Taiwan, Taiwan
Movement performance assessment
* Movement performance assessment by clinical motor assessment scales in upper extremity * executed by qualified physiotherapy * in study A, B, C
Time frame: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up
Brain images
* "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day * immediate effects of intervention in the 1st day and 24th of intervention, six-month follow-up * this examination is optional * in study A. * use regular scan examination of hospital and operated by trained qualified professionals, the attending is consulted * This examination can be stopped at any time if participants do not want to perform or feeling unwell
Time frame: immediate effects in 3 timeline
Mapping of brain cortex
* "intermediate effect of TS" means: pretest of the single TS, then application of this single TS, finally post-test of this TS in the session in the same day * immediate effects of intervention in the 1st day and 24th of intervention, one-month follow-up, six-month follow-up * in study A. * this examination is optional * use equipment of brain mapping and operated under trained staff, the attending is consulted This examination can be stopped at any time if participants do not want to perform or feeling unwell
Time frame: immediate effect in four timeline
Kinematics measure of upper extremity movement
* 1st day and 24th of intervention, one-month follow-up, six-month follow-up (This examination is optional) * signal emission marks are sticked on surface skin during motion tests * this examination is optional --in study A. * executed by trained qualified physiotherapy
Time frame: four timeline
Quality of life
* Quality of life by subjective questionnaires * executed by qualified physiotherapy --in study A, B, C.
Time frame: baseline, post-intervention, 6 month follow-up
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