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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Thermal stimulation Other
    Other Names: Thermal stimulation (FIRSTEK, Model-B401L,local company).
    Intervention Desc: hot and cold/warm and cool pads applying.
    ARM 1: Kind: Experimental
    Label: noxious thermal stimulation
    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
    ARM 2: Kind: Experimental
    Label: thermal stimulation (innocuous)
    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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM) in the longitudinal study pre, post, 1M follow-up No
Primary The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) in the longitudinal study pre, post, 1M follow-up No
Primary Functional Ambulation Category (FAC) in the longitudinal study pre, post, 1M follow-up No
Primary Barthel Index in the longitudinal study pre, post, 1M follow-up No
Secondary Postural Assessment Scale for Stroke Patients (PASS) pre, post, 1M follow-up No
Secondary Modified Ashworth Scale pre, post, 1M follow-up No
Primary 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) pre, post, 1M follow-up No
Primary 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) pre, post, 1M follow-up No
Primary The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC) pre, post, 1M follow-up No
Primary The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index pre, post, 1M follow-up No
Secondary The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS) pre, post, 1M follow-up No
Secondary The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale pre, post, 1M follow-up No

Sponsors