OBJECTIVE: To evaluate the effectiveness of thermal stimulation accompanied by either active or passive movement added to standard rehabilitation in facilitating motor and balance function of the paretic leg of acute stroke. DESIGN: Pilot, observer-blinded, randomized clinical trial. SETTING: Department of rehabilitation medicine in a general hospital. SUBJECTS: Thirty-six patients were enrolled within four weeks of the onset of a stroke causing moderate to severe leg paresis (Brunnstrom stage <= III). INTERVENTIONS: Patients were randomly assigned to thermal (standard rehabilitation plus approximately 30 to 40 minutes of thermal stimulation therapy daily for six weeks) and control (standard rehabilitation only) groups. MAIN MEASURES: Fugl-Meyer lower extremity score, Medical Research Council scale for lower extremity, Modified Motor Assessment Scale, Postural Assessment Scale for Stroke Patients Trunk Control, Berg Balance Scale, Functional Ambulation Classification and Modified Ashworth Scale. RESULTS: Patients in the thermal group experienced significantly better median scores for Fugl-Meyer lower extremity (14.0; interquartile range 10.5 to 15.5), Medical Research Council scale for lower extremity (6.0; 4.0 to 7.0), Modified Motor Assessment Scale (16.0; 12.5 to 18.5), Berg Balance Scale (28.0; 20.5 to 33.5), and Functional Ambulation Classification (2.0; 2.0 to 2.0) (all p < 0.05). The thermal group also had more independent walkers (15/17; 88.2%) than the control group (9/16; 56.3%) after six weeks (p = 0.06). No adverse effect occurred. CONCLUSIONS: Thermal stimulation accompanied by either manual facilitation or encouragement for active participation of the paretic lower limb may be an effective promising supplementary treatment for the early-phase rehabilitation of moderate to severe stroke that warrants additional study.

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