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

Hsin-Wen Hsu

Status: Completed

Conditions: Stroke

Treatments: Other: thermal stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01668420

KMUH-IRB-980332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

noxious thermal stimulation

Experimental group

Description:

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

Treatment:

Other: thermal stimulation

thermal stimulation (innocuous)

Active Comparator group

Description:

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

Treatment:

Other: thermal stimulation