NIPH Clinical Trials Search

Effects of Upper Limb HAL on Patients with Acute Stroke

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Stroke
Date of first enrollment	16/07/2025
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	In this study, subjects will be randomly assigned to the intervention and control groups and will receive 2 weeks of upper extremity functional training. The subjects will be randomly assigned to an intervention group and a control group, and will receive 2 weeks of upper limb functional training as follows. The intervention period for both groups will be 2 weeks, 5 days a week, with 40 minutes of training per day. The intervention group received HAL medical monoarticular type 3 times a week and usual occupational therapy 2 times a week (HAL medical monoarticular type 6 times, usual occupational therapy 4 times). The HAL medical monoarticular type was used in the supine or seated position, and the number of exercises and the amount of assistance with the device were determined by the number of repetitive movements. The number of exercises and the amount of exercise assistance by the equipment will be adjusted by the physician or occupational therapist as appropriate to enable high repetitive movements. The control group will receive 5 sessions of usual occupational therapy per week (10 sessions of usual occupational therapy). The evaluator will not be aware of the subject's allocation. The intervention using the HAL medical single-joint type will be conducted in a private room, so that the evaluator is not aware of the subject's assignment.

Outcome(s)

Primary Outcome

The primary endpoint in this study was a questionnaire used to assess the sense of exercise ownership.12 The questionnaire consisted of four items with factor loadings from the discomfort factor and six items with factor loadings from the sense of ownership factor. The questionnaire consists of four items with factor loadings from the discomfort factor and six items with factor loadings from the initiative factor, The total score is calculated by correcting the scores of the reversed items. In this study, this questionnaire will be used to conduct evaluations at four time points: pre-intervention, 2 weeks, 6 months, and 12 months after the intervention. The evaluation will be fully explained and self-administered by a physician or occupational therapist who is unaware of the assignment, to minimize evaluation bias.

Secondary Outcome

Secondary endpoints will include the following: motor function, activity of the paralyzed upper extremity, and cognitive and higher brain function,cognitive and higher brain function, and brain activity.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	<= 79age old
Gender	Both
Include criteria	Stroke patients with upper limb motor paralysis admitted to Tokushima University Hospital. Age less than 80 years, first stroke, Brunnstrom recovery stage II-IV, no cognitive impairment (Mini-Mental State Examination: MMSE >24), no skin disease or skin fragility at the site of application, no orthopedic disease or neuromuscular disease that inhibits upper limb movement Patients will be enrolled sequentially if they have no history of orthopedic or neuromuscular disease that interferes with upper extremity movement, have detectable biceps and triceps biopotential signals, are in stable general condition, and have controlled comorbidities.
Exclude criteria	When consent was not obtained from the patient or surrogate. If the lesion is under the tent. If a pacemaker is inserted. If the patient is diagnosed with subarachnoid hemorrhage. The patient does not have the bio-potential signals necessary to operate the HAL medical single joint type. Body size is not suitable for HAL medical single-joint type (body weight >100kg). Patient has an orthopedic disease, neuromuscular disease, or other disease that interferes with the movement of the upper limb. Other cases in which participation in this study is deemed inappropriate.