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Completed

NCT Number: NCT01418404

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University

Kaohsiung City, Taiwan, 807

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noxious TS

Other

hot, cold alternately, noxious TS in study A

Innocuous TS

Other

warm, cool alternately, Innocuious TS in study A

High Frequency of Noxious TS

Other

High Frequency of Noxious TS in study B

Low Frequency of Noxious TS

Other

Low Frequency of Noxious TS in study B

High Intensity of Noxious TS

Other

High Intensity of Noxious TS in study C

Low Intensity of Noxious TS

Other

Low Intensity of Noxious TS in study C

Primary outcomes

  1. Movement performance assessment

    Time frame: baseline, half time-line of whole intervention period, post-intervention, 1 month follow-up, 6 month follow-up

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

  2. Brain images

    Time frame: immediate effects in 3 timeline

    • "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

  3. Mapping of brain cortex

    Time frame: immediate effect in four timeline

    • "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

  4. Kinematics measure of upper extremity movement

    Time frame: four timeline

    • 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 outcomes

  1. Quality of life

    Time frame: baseline, post-intervention, 6 month follow-up

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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • E-DA Hospital
  • Kaohsiung Municipal Hsiaokang Hospital

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 17, 2011
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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