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Study Protocol for a Multicenter, Randomized Controlled Trial to Improve Upper Extremity Hemiparesis in Chronic
Daigo Sakamoto1,2, Toyohiro Hamaguchi2, Kai Murata1
1Department of Rehabilitation Medicine, The Jikei University School of Medicine Hospital, Tokyo 105-8471, Japan.
Abstract:
During recovery from upper limb motor paralysis after stroke, it is important to (1) set the exercise difficulty level according to the motor paralysis severity, (2) provide adequate exercises, and (3) motivate the patient to achieve the goal. However, these factors have not been well-formulated. This multicenter, randomized controlled trial study aims to examine the therapeutic effects of these three factors on patients undergoing a novel intervention using repetitive transcranial magnetic stimulation and intensive one-to-one training (NEURO®) and to formulate a corresponding research protocol. The control group will receive conventional NEURO® occupational therapy. In the intervention group, four practice plans will be selected according to the Fugl-Meyer assessment (FMA-UE) scores of the upper extremity. The goal is to predict the post-treatment outcomes based on the pre-treatment FMA-UE scores. Based on the degree of difficulty and amount of practice required, we can formulate a practice plan to promote upper limb motor recovery. This occupational therapy plan will be less influenced by the therapist's skill, facilitating effective rehabilitation. The study findings may be utilized to promote upper limb motor paralysis recovery and provide a basis for proposing activities of daily living adapted to upper limb function.
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