Clinical trial NCT01658293: Thermal Stimulation for Stroke Patients
Official title: Facilitation of Sensory and Motor Recovery by Means of Heat and Cold-water Stimulation on the Paretic Upper Limb of After Stroke: One Year Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Limb Paresis
Keywords: stroke
follow up
upper limb
rehabilitation
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment Scale for stroke upper limb recovery
timeFrame: one year
measure: motricity index
timeFrame: one year
Secondary outcomes:
measure: Semmes-Weinstein monofilaments for sensory functions
timeFrame: one year
measure: the modified motor assessment scale
timeFrame: one year
measure: Barthel index
timeFrame: one year
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Tzu Chi Buddhist General Hospital
Study officials:
affiliation: Tzu Chi Buddhist General Hospital, Hualien, Taiwan
name: Jia-Ching Chen, master
role: PRINCIPAL_INVESTIGATOR
References: