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The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Noxious TS
Innocuous TS
High Frequency of Noxious TS
Low Frequency of Noxious TS
High Intensity of Noxious TS
Low Intensity of Noxious TS
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Effects of TS in U/E motor recovery, Brain mapping, Kinematics analysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kaohsiung Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Noxious TS in study A

Innocuous TS

High Frequency of Noxious TS

Low Frequency of Noxious TS

High Intensity of Noxious TS

Low Intensity of Noxious TS

Arm Description

Noxious TS in study A

Innocuous 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

Outcomes

Primary Outcome Measures

Movement performance assessment
Movement performance assessment by clinical motor assessment scales in upper extremity executed by qualified physiotherapy in study A, B, C
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
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
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

Secondary Outcome Measures

Quality of life
Quality of life by subjective questionnaires executed by qualified physiotherapy --in study A, B, C.

Full Information

First Posted
June 26, 2011
Last Updated
April 6, 2015
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
E-DA Hospital, Kaohsiung Municipal Hsiaokang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01418404
Brief Title
The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
Official Title
The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
E-DA Hospital, Kaohsiung Municipal Hsiaokang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Effects of TS in U/E motor recovery, Brain mapping, Kinematics analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noxious TS in study A
Arm Type
Experimental
Arm Description
Noxious TS in study A
Arm Title
Innocuous TS
Arm Type
Active Comparator
Arm Description
Innocuous TS in study A
Arm Title
High Frequency of Noxious TS
Arm Type
Experimental
Arm Description
High Frequency of Noxious TS in study B
Arm Title
Low Frequency of Noxious TS
Arm Type
Active Comparator
Arm Description
Low Frequency of Noxious TS in study B
Arm Title
High Intensity of Noxious TS
Arm Type
Experimental
Arm Description
High Intensity of Noxious TS in study C
Arm Title
Low Intensity of Noxious TS
Arm Type
Active Comparator
Arm Description
Low Intensity of Noxious TS in study C
Intervention Type
Other
Intervention Name(s)
Noxious TS
Intervention Description
hot, cold alternately, noxious TS in study A
Intervention Type
Other
Intervention Name(s)
Innocuous TS
Intervention Description
warm, cool alternately, Innocuious TS in study A
Intervention Type
Other
Intervention Name(s)
High Frequency of Noxious TS
Intervention Description
High Frequency of Noxious TS in study B
Intervention Type
Other
Intervention Name(s)
Low Frequency of Noxious TS
Intervention Description
Low Frequency of Noxious TS in study B
Intervention Type
Other
Intervention Name(s)
High Intensity of Noxious TS
Intervention Description
High Intensity of Noxious TS in study C
Intervention Type
Other
Intervention Name(s)
Low Intensity of Noxious TS
Intervention Description
Low Intensity of Noxious TS in study C
Primary Outcome Measure Information:
Title
Movement performance assessment
Description
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
Title
Brain images
Description
"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
Title
Mapping of brain cortex
Description
"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
Title
Kinematics measure of upper extremity movement
Description
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
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life by subjective questionnaires executed by qualified physiotherapy --in study A, B, C.
Time Frame
baseline, post-intervention, 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first-ever ischemic stroke; no severe cognitive impairments and able to follow instructions; sit on a chair for more than 30 minutes independently. Exclusion Criteria: musculoskeletal or cardiac disorders that potentially interferes with experimental tests; diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy; speech disorder or global aphasia; skin problems at the sites of stimulation; 6.contraindications of heat or ice application.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau-Hong Lin, Professor
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung city
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32118788
Citation
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.
Results Reference
derived

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The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

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