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Clinical Trials/JPRN-jRCTs032230039
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.

Registry
who.int
Start Date
April 17, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Matsumaru Yuji

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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