Robot suit HAL in children

JRCT ID: jRCTs032180430

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cerebral palsy, spina bifida, cranial nerve diseases and spinal cord diseases
• Date of first enrollment: 07/01/2019
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Attach HAL, repeat bending progressive exercise, standing position, and walking exercise of optional upper and lower limbs.

Outcome(s)

Primary Outcome

Adverse event
Malfunction of HAL and accessory equipment
Executability of research protocol

Secondary Outcome

Vital signs
Physical function evaluation
Functional Independence measurement
Neurophysiological examination

Key inclusion & exclusion criteria

• Age minimum: 3 years or older who can attach HAL
• Age maximum: Installation of equipment Unlimited as much as pos
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kamada Hiroshi
• Source(s) of Monetary Support: University of Tsukuba Hospital
• Secondary ID(s): UMIN000030950