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

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ClinicalTrials.gov Identifier: NCT01668420
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : November 9, 2012
Sponsor:
Collaborator:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Information provided by (Responsible Party):
Hsin-Wen Hsu, Kaohsiung Medical University Chung-Ho Memorial Hospital

August 12, 2012
August 20, 2012
November 9, 2012
December 2009
December 2010   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
  • 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.
  • The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM) in the longitudinal study [ 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.
  • The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) in the longitudinal study [ 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.
  • Functional Ambulation Category (FAC) in the longitudinal study [ 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.
  • Barthel Index in the longitudinal study [ 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.
Complete list of historical versions of study NCT01668420 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
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Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Other: thermal stimulation
hot and cold/warm and cool pads applying.
Other Name: Thermal stimulation (FIRSTEK, Model-B401L,local company).
  • 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
    Intervention: Other: thermal stimulation
  • 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
    Intervention: Other: thermal stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
Same as current
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01668420
KMUH-IRB-980332
No
Not Provided
Not Provided
Hsin-Wen Hsu, Kaohsiung Medical University Chung-Ho Memorial Hospital
Hsin-Wen Hsu
Kaohsiung Medical University Chung-Ho Memorial Hospital
Principal Investigator: Hsin-Wen Hsin, graduated Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP