NCT01418404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

4.4 years

First QC Date

June 26, 2011

Last Update Submit

April 6, 2015

Conditions

Stroke

Keywords

StrokeEffects of TS in U/E motor recoveryBrain mappingKinematics analysis

Outcome Measures

Primary Outcomes (4)

  • Movement performance assessment

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

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

  • 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

    immediate effects in 3 timeline

  • 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

    immediate effect in four timeline

  • 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

    four timeline

Secondary Outcomes (1)

  • Quality of life

    baseline, post-intervention, 6 month follow-up

Study Arms (6)

Noxious TS in study A

EXPERIMENTAL

Noxious TS in study A

Other: Noxious TS

Innocuous TS

ACTIVE COMPARATOR

Innocuous TS in study A

Other: Innocuous TS

High Frequency of Noxious TS

EXPERIMENTAL

High Frequency of Noxious TS in study B

Other: High Frequency of Noxious TS

Low Frequency of Noxious TS

ACTIVE COMPARATOR

Low Frequency of Noxious TS in study B

Other: Low Frequency of Noxious TS

High Intensity of Noxious TS

EXPERIMENTAL

High Intensity of Noxious TS in study C

Other: High Intensity of Noxious TS

Low Intensity of Noxious TS

ACTIVE COMPARATOR

Low Intensity of Noxious TS in study C

Other: Low Intensity of Noxious TS

Interventions

Noxious TSOTHER

hot, cold alternately, noxious TS in study A

Noxious TS in study A
Innocuous TSOTHER

warm, cool alternately, Innocuious TS in study A

Innocuous TS
High Frequency of Noxious TSOTHER

High Frequency of Noxious TS in study B

High Frequency of Noxious TS
Low Frequency of Noxious TSOTHER

Low Frequency of Noxious TS in study B

Low Frequency of Noxious TS
High Intensity of Noxious TSOTHER

High Intensity of Noxious TS in study C

High Intensity of Noxious TS
Low Intensity of Noxious TSOTHER

Low Intensity of Noxious TS in study C

Low Intensity of Noxious TS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;
  • contraindications of heat or ice application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan, 807, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 32118788DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jau-Hong Lin, Professor

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Department of Physical Therapy, Kaohsiung Medical University, Taiwan

Study Record Dates

First Submitted

June 26, 2011

First Posted

August 17, 2011

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

TW(1)