Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke

NCT ID: NCT01668420

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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The thermal stimulation have been proven effective in upper extremity of stroke patients. Therefore, this study explored the efficacy of thermal stimulation in lower extremity of stroke patients.

Detailed Description

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There are two groups of stroke patients (onset \> 3 months) in this study. The independent factor is temperature of the alternated heat and cold applying.

Conditions

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Stroke

Keywords

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thermal stimulation lower extremity temperature efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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noxious thermal stimulation

Heat-pain:46-47°C and Cold-pain:2-3°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given

Group Type EXPERIMENTAL

thermal stimulation

Intervention Type OTHER

hot and cold/warm and cool pads applying.

thermal stimulation (innocuous)

Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given

Group Type ACTIVE_COMPARATOR

thermal stimulation

Intervention Type OTHER

hot and cold/warm and cool pads applying.

Interventions

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thermal stimulation

hot and cold/warm and cool pads applying.

Intervention Type OTHER

Other Intervention Names

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Thermal stimulation (FIRSTEK, Model-B401L,local company).

Eligibility Criteria

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Inclusion Criteria

The inclusive criteria:

* first-ever stroke
* stroke onset \> 3 months and \< 3 years before the study enrollment
* unilateral hemiplegia
* ability to sit on a chair \> 30 minutes independently
* able to follow verbal instructions
* age between 18 y/o and 80 y/o
* be willing to participate in this study and gave their informed consent

The exclusive criteria:

* skin disease, skin injuries, burns, or fresh scars over the TS application area
* contraindication of ice or heat application
* speech disorder or global aphasia
* musculoskeletal or cardiac disorders that could potentially interfere
* diabetic history or sensory impairment attributable to neuropathy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role collaborator

Hsin-Wen Hsu

OTHER

Sponsor Role lead

Responsible Party

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Hsin-Wen Hsu

physical therapist (graduated student)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hsin-Wen Hsin, graduated

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUH-IRB-980332

Identifier Type: -

Identifier Source: org_study_id