JPRN-jRCTs032180430
Completed
Phase 1
Feasibility and safety test of functional therapy by robot suit HAL for motor function disorder in children - Feasibility and safety test of robot suit HAL in children
Kamada Hiroshi0 sites5 target enrollmentMarch 27, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kamada Hiroshi
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Gait training using HAL for children patients is a feasible method for various types of gait disorders.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patient who can consent to the document with his / her family (guardian). Request cooperation from the substitute.
- •2\. Patient able to attach HAL. (pediatric patients whose height is 80 cm or more, body size such as thigh length, lower leg length, waist width, etc. can be fitted, HAL (S or 2 S size) can be attached, 3 years or older, Intention indication available, can understand robot fitting.)
- •3\. During the study period, patients who can continue hospitalization or outpatient visits according to the study schedule.
Exclusion Criteria
- •1\. Patients who have difficulty in voluntary limb activity according to instructions due to consciousness disturbance or severe dementia.
- •2\. Patients who are severely deformed in the skeletal system such as osteoarthritis, degenerative spondylosis, scoliosis, and are difficult to train including joint movement. Patient who is difficult to wear HAL.
- •3\. Patients who have complications such as bleeding tendency or osteoporosis which are problems in training.
- •4\. Patients who can not affix HAL biomedical electrodes due to skin diseases.
- •5\. Patients who participated in other research within 12 weeks of this clinical study.
- •6\. Clinical trial Patients who are judged to be inappropriate for participation in this study by a physician or shared medical doctor.
Outcomes
Primary Outcomes
Not specified
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