Thermal Stimulation for Stroke Patients (TSSP)

Buddhist Tzu Chi General Hospital

Status

Completed

Conditions

Stroke

Upper Limb Paresis

Treatments

Behavioral: thermal stimulation

Behavioral: control group ergometer exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT01658293

IRB100-25

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

a first-time ischemic or hemorrhagic stroke.
no severe diabetes or peripheral vascular disease causing sensory deficits.
no cognition problem and follow directions indicated by therapist during experiment.
motor deficit of the upper limb under (including) Brunnstrom stage IV, either in the arm or hand.

Exclusion criteria

a cardiac disease or orthopedic problem history,
medically unstable such as experienced unstable angina, uncontrolled hypertension according to the treating physician, psychological history before stroke.