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

This study has been completed.
Sponsor:
Collaborator:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by (Responsible Party):
Hsin-Wen Hsu, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01668420
First received: August 12, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Stroke
Other: thermal stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Thermal stimulation (FIRSTEK, Model-B401L,local company).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668420

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Sponsors and Collaborators
Hsin-Wen Hsu
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Hsin-Wen Hsin, graduated Kaohsiung Medical University Chung-Ho Memorial Hospital
  More Information

No publications provided

Responsible Party: Hsin-Wen Hsu, physical therapist (graduated student), Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01668420     History of Changes
Other Study ID Numbers: KMUH-IRB-980332
Study First Received: August 12, 2012
Last Updated: November 7, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
thermal stimulation
lower extremity
temperature
efficacy

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014