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The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor:
Collaborators:
E-DA Hospital
Kaohsiung Municipal Hsiaokang Hospital
Information provided by (Responsible Party):
Jau-Hong Lin, Professor, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01418404
First received: June 26, 2011
Last updated: December 3, 2013
Last verified: December 2013

June 26, 2011
December 3, 2013
January 2010
June 2014   (final data collection date for primary outcome measure)
  • Movement performance assessment [ Time Frame: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up ] [ Designated as safety issue: No ]
    • Movement performance assessment by clinical motor assessment scales in upper extremity
    • executed by qualified physiotherapy
    • in study A, B, C
  • Brain images [ Time Frame: immediate effects in 3 timeline ] [ Designated as safety issue: No ]
    • "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 [ Time Frame: immediate effect in four timeline ] [ Designated as safety issue: No ]
    • "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 [ Time Frame: four timeline ] [ Designated as safety issue: No ]
    • 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
  • immediate anatomical and functional cortical changes as a measure of cortical reorganization [ Time Frame: Change from baseline in cortical reorganization at post-treatment and follow-ups(1 month and 6 months) ] [ Designated as safety issue: No ]
    Functional Magnetic Resonan Images
  • quality of upper extremity movements as a measure of upper extremity motor function [ Time Frame: Change from baseline in UE motor function at post-treatment and follow-ups(1 month and 6 months) ] [ Designated as safety issue: No ]
    fugl-meyer motor test,upper extremity
  • mapping area of cortical excitability as a measure of effect on reorganization and functional motor recovery [ Time Frame: Change from baseline in cortical reorganization at post-treatment and follow-ups(1 month and 6 months) ] [ Designated as safety issue: No ]
    Transcranial Magnetic Stimulation
Complete list of historical versions of study NCT01418404 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: baseline, post-intervention, 6 month follow-up ] [ Designated as safety issue: No ]
  • Quality of life by subjective questionnaires
  • executed by qualified physiotherapy --in study A, B, C.
  • muscles strength as a measure of upper extremities deficits [ Time Frame: baseline, post-treatment, and follow-ups (3 months, 6 months, and 1 year) ] [ Designated as safety issue: No ]
    Motricity Index
  • independence to score the ability of a patient to care for himself [ Time Frame: baseline, post-treatment, and follow-ups (3 months, 6 months, and 1 year) ] [ Designated as safety issue: No ]
    Barthel Index
  • quality of patients perform tasks as a measure of ability and motor function [ Time Frame: baseline, post-treatment, and follow-ups (3 months, 6 months, and 1 year) ] [ Designated as safety issue: No ]
    Action Research Arm Test
  • changes of the muscle tone as a measure of improvement in nervous system [ Time Frame: baseline, post-treatment, and follow-ups (3 months, 6 months, and 1 year) ] [ Designated as safety issue: No ]
    Modified Ashworth Scale
Not Provided
Not Provided
 
The Application of Thermal Stimulation on Functional Recovery of Stroke Patients
The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Other: Noxious TS
    hot, cold alternately
    Other Name: thermal stimulation (TS)
  • Device: Innocuous TS
    warm, cool alternately
    Other Name: 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
    Other Name: Low Frequency of Noxious TS in study B
  • Other: High Intensity of Noxious TS
    Other Name: High Intensity of Noxious TS in study C
  • Other: Low Intensity of Noxious TS
    Low Intensity of Noxious TS in study C
  • Experimental: Noxious TS in study A
    Noxious TS in study A
    Intervention: Other: Noxious TS
  • Active Comparator: Innocuous TS
    Innocuous TS in study A
    Intervention: Device: Innocuous TS
  • Experimental: High Frequency of Noxious TS
    High Frequency of Noxious TS in study B
    Intervention: Other: High Frequency of Noxious TS
  • Active Comparator: Low Frequency of Noxious TS
    Low Frequency of Noxious TS in study B
    Intervention: Other: Low Frequency of Noxious TS
  • Experimental: High Intensity of Noxious TS
    High Intensity of Noxious TS in study C
    Intervention: Other: High Intensity of Noxious TS
  • Active Comparator: Low Intensity of Noxious TS
    Low Intensity of Noxious TS in study C
    Intervention: Other: Low Intensity of Noxious TS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2014
June 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years
No
Contact: Jau-Hong Lin, Professor 886-7-3121101 ext 2674 jhlin@kmu.edu.tw
Taiwan
 
NCT01418404
NHRI-EX99-9907PI
No
Jau-Hong Lin, Professor, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
  • E-DA Hospital
  • Kaohsiung Municipal Hsiaokang Hospital
Principal Investigator: Jau-Hong Lin, Professor Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP