Thermal Stimulation for Stroke Patients "TSSP"

Recruiting

Phase N/A Results N/A

Trial Description

Sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. Thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. However, whether hot- and cold-water stimulation alternatively based on thermal stimulation also has the effect still remains unknown. The aim of present study is to investigate the facilitated effect of hot and cold water stimulation alternatively on upper limb after stroke.

Detailed Description

Stroke patients from department of rehabilitation in Tzu Chi general hospital will be recruited and randomized into two groups, one for experimental group and the other for control group. In addition to receiving routine standard rehabilitation for both groups, the experimental group will receive additional hot- and cold-water stimulation alternatively for five times one session, consecutive four sessions a set, one set for 30 minutes a day and five sets a week for six weeks. The control group will be given ergometer exercises with the similar duration as experimental group. Both groups will be evaluated at baseline before TS and every two weeks till six weeks after TS, then at 3, 6 and 12 months for follow-up. A variety of evaluations used in the present study include Semmes-Weinstein monofilaments for sensory functions; Brunnstrom's stage, Fugl-Meyer Assessment Scale and Motricity Index were used for upper limb motor control and strength; Box and block test for hand dexterity. The modified Motor Assessment Scale and Barthel Index are utilized for evaluating general motor functions and daily activity performance, respectively. The modified Ashworth scale is used for change of muscle tone of upper limb.

Conditions

Interventions

  • Thermal stimulation Other
    Other Names: Thermal stimulation (FIRSTEK, Model-B401L,local company).
    Intervention Desc: The heat and cold-water will be added to the thermal group for 30-40minutes a session daily,five sessions a week for six weeks.
    ARM 1: Kind: Experimental
    Label: thermal stimulation
    Description: The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.
  • Control group ergometer exercises Behavioral
    Intervention Desc: The control group will be given ergometer exercises with the similar duration as experimental group.
    ARM 1: Kind: Experimental
    Label: control group
    Description: The control group receiving the similar intensity of ergometer exercise as the experimental group.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment Scale for stroke upper limb recovery one year No
Primary motricity index one year No
Secondary Semmes-Weinstein monofilaments for sensory functions one year No
Secondary the modified motor assessment scale one year No
Secondary Barthel index one year No

Sponsors