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StrokeNCT01418404

The Application of Thermal Stimulation on Functional Recovery of Stroke Patients

A study testing Noxious TS, Innocuous TS and High Frequency of Noxious TS in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Noxious TS, Innocuous TS and High Frequency of Noxious TS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteTaiwan
Study dates
Jan 2010to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • first-ever ischemic stroke;
  • no severe cognitive impairments and able to follow instructions;
  • sit on a chair for more than 30 minutes independently.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Medical University

    Kaohsiung City, Taiwan, 807

Other trials in Taiwan

About this study

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.

Read the 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
Being tested
Noxious TS, Innocuous TS, High Frequency of Noxious TS, Low Frequency of Noxious TS, High Intensity of Noxious TS
Keywords
Stroke, Effects of TS in U/E motor recovery, Brain mapping, Kinematics analysis
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Noxious TSOther

    hot, cold alternately, noxious TS in study A

  • Innocuous TSOther

    warm, cool alternately, Innocuious TS in study A

  • High Frequency of Noxious TSOther

    High Frequency of Noxious TS in study B

  • Low Frequency of Noxious TSOther

    Low Frequency of Noxious TS in study B

  • High Intensity of Noxious TSOther

    High Intensity of Noxious TS in study C

  • Low Intensity of Noxious TSOther

    Low Intensity of Noxious TS in study C

Study groups in NCT01418404
Study groupRoleWhat they receive
Noxious TS in study AExperimentalNoxious TS in study A
Receives: Other: Noxious TS
Innocuous TSActive comparatorInnocuous TS in study A
Receives: Other: Innocuous TS
High Frequency of Noxious TSExperimentalHigh Frequency of Noxious TS in study B
Receives: Other: High Frequency of Noxious TS
Low Frequency of Noxious TSActive comparatorLow Frequency of Noxious TS in study B
Receives: Other: Low Frequency of Noxious TS
High Intensity of Noxious TSExperimentalHigh Intensity of Noxious TS in study C
Receives: Other: High Intensity of Noxious TS
Low Intensity of Noxious TSActive comparatorLow Intensity of Noxious TS in study C
Receives: Other: Low Intensity of Noxious TS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement performance assessment

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

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

  2. 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

    Measured: immediate effects in 3 timeline

  3. 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

    Measured: immediate effect in four timeline

  4. 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

    Measured: four timeline

Secondary outcomes (1)

  1. Quality of life

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

    Measured: baseline, post-intervention, 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01418404
Sponsor's protocol ID
NHRI-EX99-9907PI
Status last verified
Apr 2015
First submitted
26 Jun 2011
Last updated
8 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32118788

Questions about this trial

What is this clinical trial studying?

A study testing Noxious TS, Innocuous TS and High Frequency of Noxious TS in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01418404, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.

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