|9 Apr '15||
Trial was updated to "N/A."
A location was updated in Kaohsiung city.
The overall status was removed for Kaohsiung Medical University.
|17 Jul '12||
Trial name was updated.
The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
The Summary of Purpose was updated.
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.
Thermal stimulation (TS) has been found to be an effective strategy by a domestic research group to facilitate sensory and motor recovery of upper extremity (UE) after acute stroke. However, the efficacy of TS in patients with subacute or chronic stroke, the optimal therapeutic parameter settings, and the recovery mechanism of TS intervention remain unknown. Moreover, further improvements are needed to overcome the limitation of inconstant temperature output using traditional therapeutic hot or cold packs. TS is simple and practicable, as well as potentially convenient and easy to apply in both clinical and home-care-based settings. Thus, we intend to initiate this 5-year project to: (i) assess the immediate and long-term effects of TS on paretic limb function in stroke patients with various levels of impairment and recovery stages (i.e., acute, subacute, or chronic stage); (ii) investigate the effect of TS at different therapeutic parameter settings; (iii) verify the intervention effects and the recovery mechanism of TS; and (iv) examine the quasi-cause relationships between UE functional recovery in clinical measures and the mechanism of TS in kinematic measures and cortical image findings.
The description was updated.
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).
In this 5-year project, we will recruit 270 first-stroke patients from the Neurology and the Rehabilitation departments in our university hospital. This 5-year study includes 3 main parts: A, B, and C. Part A comprises three RCTs investigating the effects of frequency, intensity, and treatment area of TS intervention parameter settings on paretic UE recovery at different recovery phases. Part B will use fMRI, Transcranial Magnetic Stimulation, and a motion analysis system to examine the TS intervention effects and (1) time-dependent changes in cortical neuroplasticity (project B1) and (2) the kinematic changes in a functional reach task (project B2) related to the UE recovery mechanism in the first 6 months post-stroke. In Part C, longitudinal, quasi-causal relationships between UE functional improvements in clinical measures (A projects) and mechanisms of UE recovery post-stroke in cortical activation and kinematic measures (B projects) will be examined.
The eligibility criteria were updated.
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.
Inclusion Criteria: 1. first-ever stroke survivors with unilateral hemispheric lesions from a ischemic stroke; 2. no severe cognitive impairments and able to follow instructions; 3. 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.