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

November 7, 2012 updated by: Hsin-Wen Hsu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: thermal stimulation
hot and cold/warm and cool pads applying.
Other Names:
  • Thermal stimulation (FIRSTEK, Model-B401L,local company).
Active Comparator: 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
Other: thermal stimulation
hot and cold/warm and cool pads applying.
Other Names:
  • Thermal stimulation (FIRSTEK, Model-B401L,local company).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM)
Time Frame: pre, post, 1M follow-up
The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement (LE-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
pre, post, 1M follow-up
The change score from baseline to post-treatment and baseline to 1M follow-up in the mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM)
Time Frame: pre, post, 1M follow-up
The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
pre, post, 1M follow-up
The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)
Time Frame: pre, post, 1M follow-up
Functional Ambulation Category (FAC) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
pre, post, 1M follow-up
The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index
Time Frame: pre, post, 1M follow-up
Barthel Index (BI) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
pre, post, 1M follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)
Time Frame: pre, post, 1M follow-up
Postural Assessment Scale for Stroke Patients (PASS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
pre, post, 1M follow-up
The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale
Time Frame: pre, post, 1M follow-up
Modified Ashworth Scale (MAS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
pre, post, 1M follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hsin-Wen Hsu

Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Hsin-Wen Hsin, graduated, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 12, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-980332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on thermal stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe