The feasibility and safety study of the functional recovery therapy using a HAL for the central motor dysfunction.

Phase 2

Recruiting

• Conditions: Stroke, brain/spinal cord injury, brain/spinal cord tumor, neuromuscular disease

• Registration Number: JPRN-jRCTs032180149
• Lead Sponsor: Yamazaki Masashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

Patients satisfying all of the following criteria are subject to this clinical trial.
1. A patient can consent by a document. If the handwriting is difficult due to the primary disease, it is assumed to obtain a document consent from ghost-writing user.
2. A patient 16 years of age or older. The consent of the legal representative's is needed for the patients of minors 16-19 years of age.
3. A patient who are hospitalized in the general ward, ICU or HCU.
4. A patient can wear HAL, weighing 40-100 kg, height is 150-190 cm.
5. A patient who can be hospitalized continuously along the test schedule.

Exclusion Criteria

Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
1. It is difficult to perform the volantary movement of the limbs in accordance with the instructions due to the disturbance of consciousness or dementia.
2. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system.
3. A patient has a complication, which can disturb the treatment using HAL.
4. The biological edectrode for HAL can not be affixed to patient's skin due to the skin disease.
5. A patient who participated in other studies within 12 weeks of the start of this clinical study.
6. A patient whose clinical trial investigator or clinical trial sharing doctor judged inappropriate participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Adverse event <br>2. Failure of HAL and ancillary equipment <br>3. Feasibility of study protocol