JPRN-jRCTs032230039
Recruiting
Phase 2
A randomized controlled trial of the lumbar-type of the Wearable Cyborg HAL (Hybrid Assistive Limb) for the safety and efficacy in hemiplegic patients with acute stroke
Matsumaru Yuji0 sites44 target enrollmentApril 17, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cerebral infarction and cerebral hemorrhage patients with hemiplegia and sit-to-stand disorder
- Sponsor
- Matsumaru Yuji
- Enrollment
- 44
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients who can agree to the document by themselves. (However, if writing is difficult, set a writer)
- •2\) Patients aged 16 years or older. (If you are under 18 years old, in addition to the signature of the person himself/herself, a signature by a parent or guardian is also needed)
- •3\) Patients within 2 to 21 days after onset. (The day of stroke onset is treated as day 0\)
- •4\) Patients with Functional Ambulation Category (FAC) from 0 to 2\.
- •5\) Patients with FAC of 4 or more before onset.
- •6\) Patients who can wear the lumbar\-type of HAL. (Height is assumed to be 150 cm\-190 cm, but the condition of use is not height, but for patients whose, body size such as thigh length, lower leg length, waist width, etc. fits)
Exclusion Criteria
- •1\) Patients who have difficulty performing voluntary limb movements according to instructions due to consciousness disorder or cognitive decline.
- •2\) Patients who have difficulty in training joint exercises or wearing lumbar\-type of HAL due to complications such as heart disease and musculoskeletal system, which are problems during exercise.
- •3\) Patients who cannot attach lumbar\-type of HAL bio\-electrode due to skin diseases.
- •4\) Patients who participated in other interventional studies within 12 weeks of the start of this clinical study.
- •5\) Patient who is judged to be medically unstable by the principal investigator or member doctors after comprehensively considering physical findings, examination findings, etc.
Outcomes
Primary Outcomes
Not specified
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