NCT01418404

The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	Noxious TS	hot, cold alternately, noxious TS in study A
OTHER	Innocuous TS	warm, cool alternately, Innocuious TS in study A
OTHER	High Frequency of Noxious TS	High Frequency of Noxious TS in study B
OTHER	Low Frequency of Noxious TS	Low Frequency of Noxious TS in study B
OTHER	High Intensity of Noxious TS	High Intensity of Noxious TS in study C
OTHER	Low Intensity of Noxious TS	Low Intensity of Noxious TS in study C

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2011-08-17
• Last updated: 2015-04-08

Locations

1 site across 1 country: Taiwan