Clinical trial NCT01668420: Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Official title: Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: thermal stimulation
lower extremity
temperature
efficacy
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University Chung-Ho Memorial Hospital
First posted: 2012-08-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
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)
timeFrame: pre, post, 1M follow-up
measure: 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)
timeFrame: pre, post, 1M follow-up
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)
timeFrame: pre, post, 1M follow-up
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index
timeFrame: pre, post, 1M follow-up
Secondary outcomes:
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)
timeFrame: pre, post, 1M follow-up
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale
timeFrame: pre, post, 1M follow-up
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Hsin-Wen Hsin, graduated
role: PRINCIPAL_INVESTIGATOR
References: