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The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

This study is currently recruiting participants.
Verified July 2012 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: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Stroke
 Device: Thermal stimulation (TS)
Device: Noxious thermal stimulation
Device: Thermal stimulation system
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • 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: intermediate 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 270
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Noxious TS
Accepting heat and cold alternatively applying in study A.
 Device: Thermal stimulation (TS)
One group accepts heat and cold applying alternately while another group warm and cool applying in study A.
Other Names:
  • FIRSTEK
  • Model-B401L, B-300 (local company customized)
Active Comparator: Innocuous TS
Accepting warm and cool alternatively applying in study A.
 Device: Thermal stimulation (TS)
One group accepts heat and cold applying alternately while another group warm and cool applying in study A.
Other Names:
  • FIRSTEK
  • Model-B401L, B-300 (local company customized)
Experimental: High frequency noxious TS
5 days/week in in study B.
 Device: Noxious thermal stimulation
Using the Noxious thermal stimulation system. One group is 5 days/week while another is 3 days/week in study B.
Other Names:
  • FIRSTEK
  • Model-B401L, B-300 (local company customized)
Active Comparator: Low frequency noxious TS
3 days/week in study B.
 Device: Noxious thermal stimulation
Using the Noxious thermal stimulation system. One group is 5 days/week while another is 3 days/week in study B.
Other Names:
  • FIRSTEK
  • Model-B401L, B-300 (local company customized)
Experimental: High intensity of noxious TS
High intensity (60 minutes) by noxious thermal stimulation in study C.
 Device: Thermal stimulation system
One group accept 60 minutes noxious TS and another accept 30 minutes noxious TS in study C.
Other Names:
  • FIRSTEK
  • Model-B401L, B-300 (local company customized)
Active Comparator: Low intensity of noxious TS
Low intensity (30 minutes) of noxious thermal stimulation applying in study C.
 Device: Thermal stimulation system
One group accept 60 minutes noxious TS and another accept 30 minutes noxious TS in study C.
Other Names:
  • FIRSTEK
  • Model-B401L, B-300 (local company customized)

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418404

Contacts
Contact: Jau-Hong Lin, Professor 886-7-3121101 ext 2674 jhlin@kmu.edu.tw

Locations
Taiwan
Kaohsiung Medical University Recruiting
Kaohsiung city, Taiwan, 807
Contact: Jau-Hong Lin, Professor     886-7-3121101 ext 2674     jhlin@kmu.edu.tw    
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
E-DA Hospital
Kaohsiung Municipal Hsiaokang Hospital
Investigators
Principal Investigator: Jau-Hong Lin, Professor Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: Jau-Hong Lin, Professor, Professor in Department of Physical Therapy, Kaohsiung Medical University, Taiwan, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01418404     History of Changes
Other Study ID Numbers: NHRI-EX99-9907PI
Study First Received: June 26, 2011
Last Updated: July 13, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Stroke
Effects of TS in U/E motor recovery
Brain mapping
Kinematics analysis

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013