The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

Kaohsiung Medical University

Status: Completed

Conditions: Stroke

Treatments: Other: Low Frequency of Noxious TS; Other: Low Intensity of Noxious TS; Other: High Frequency of Noxious TS; Other: High Intensity of Noxious TS; Other: Noxious TS; Other: Innocuous TS

Study type: Interventional

Funder types: Other

Identifiers

NCT01418404

NHRI-EX99-9907PI

Details and patient eligibility

About

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.

Full 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).

Enrollment: 220 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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220 participants in 6 patient groups

Noxious TS in study A

Experimental group

Description:

Noxious TS in study A

Treatment:

Other: Noxious TS

Innocuous TS

Active Comparator group

Description:

Innocuous TS in study A

Treatment:

Other: Innocuous TS

High Frequency of Noxious TS

Experimental group

Description:

High Frequency of Noxious TS in study B

Treatment:

Other: High Frequency of Noxious TS

Low Frequency of Noxious TS

Active Comparator group

Description:

Low Frequency of Noxious TS in study B

Treatment:

Other: Low Frequency of Noxious TS

High Intensity of Noxious TS

Experimental group

Description:

High Intensity of Noxious TS in study C

Treatment:

Other: High Intensity of Noxious TS

Low Intensity of Noxious TS

Active Comparator group

Description:

Low Intensity of Noxious TS in study C

Treatment:

Other: Low Intensity of Noxious TS