The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

NCT ID: NCT01418404

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-12-31

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).

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Noxious TS in study A

Noxious TS in study A

Group Type: EXPERIMENTAL

Noxious TS

Intervention Type: OTHER

hot, cold alternately, noxious TS in study A

Innocuous TS

Innocuous TS in study A

Group Type: ACTIVE_COMPARATOR

Innocuous TS

Intervention Type: OTHER

warm, cool alternately, Innocuious TS in study A

High Frequency of Noxious TS

High Frequency of Noxious TS in study B

Group Type: EXPERIMENTAL

High Frequency of Noxious TS

Intervention Type: OTHER

High Frequency of Noxious TS in study B

Low Frequency of Noxious TS

Low Frequency of Noxious TS in study B

Group Type: ACTIVE_COMPARATOR

Low Frequency of Noxious TS

Intervention Type: OTHER

Low Frequency of Noxious TS in study B

High Intensity of Noxious TS

High Intensity of Noxious TS in study C

Group Type: EXPERIMENTAL

High Intensity of Noxious TS

Intervention Type: OTHER

High Intensity of Noxious TS in study C

Low Intensity of Noxious TS

Low Intensity of Noxious TS in study C

Group Type: ACTIVE_COMPARATOR

Low Intensity of Noxious TS

Intervention Type: OTHER

Low Intensity of Noxious TS in study C

Interventions

Noxious TS

hot, cold alternately, noxious TS in study A

Intervention Type: OTHER

Innocuous TS

warm, cool alternately, Innocuious TS in study A

Intervention Type: OTHER

High Frequency of Noxious TS

High Frequency of Noxious TS in study B

Intervention Type: OTHER

Low Frequency of Noxious TS

Low Frequency of Noxious TS in study B

Intervention Type: OTHER

High Intensity of Noxious TS

High Intensity of Noxious TS in study C

Intervention Type: OTHER

Low Intensity of Noxious TS

Low Intensity of Noxious TS in study C

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

E-DA Hospital

OTHER

Sponsor Role: collaborator

Kaohsiung Municipal Hsiaokang Hospital

OTHER_GOV

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jau-Hong Lin, Professor

Professor in Department of Physical Therapy, Kaohsiung Medical University, Taiwan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jau-Hong Lin, Professor

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Kaohsiung Medical University

Kaohsiung City, Taiwan, Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 32118788 (View on PubMed)

Other Identifiers

NHRI-EX99-9907PI

Identifier Type: -

Identifier Source: org_study_id