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Clinical Trials/JPRN-jRCTs062200031
JPRN-jRCTs062200031
Recruiting
Phase 1

Clinical application of medical robot for gait rehabilitation after lower limb amputation

shio Kai0 sites20 target enrollmentDecember 1, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Those who plan to have a thigh or lower leg amputation
Sponsor
shio Kai
Enrollment
20
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 1, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
shio Kai

Eligibility Criteria

Inclusion Criteria

  • 1\. Those who are planning to perform unilateral thigh/crus amputation at this hospital (causal diseases do not matter)
  • 2\. Person who can agree on the document
  • 3\. Those who are 16 years or older at the time of obtaining consent
  • 4\. Persons with a height of 150 cm or more and 175 cm or less
  • 5\. Weight: 40kg or more and 100kg or less
  • 6\. Those who are admitted by a doctor who can wear a post\-operative artificial leg and can walk.
  • 7\. Those who can be hospitalized according to the treatment implementation schedule during the treatment period

Exclusion Criteria

  • 1\. Those who have undergone lower limb amputation on the opposite side
  • 2\. Ventilators, respiratory aids, oxygen therapy, and those who are judged by a doctor to require ventilator or respiratory aids or oxygen therapy.
  • 3\. Those who have difficulty in walking training due to dyspnea or heart failure during exertion
  • 4\. Those who have severe skeletal deformities such as osteoarthritis, osteo spondylosis, and scoliosis, and who are considered to be difficult to walk.
  • 5\. Those who have complications such as bleeding tendency and osteoporosis, which are problems in walking practice, and those who are admitted to be unable to walk with a postoperative thigh or lower leg prosthesis.
  • 6\. Those who have serious liver disorder, renal disorder or cardiovascular disease
  • 7\. Those who are pregnant, who may be pregnant, and who wish to become pregnant during the research period.
  • 8\. Persons who cannot attach HAL\-ML05 electrodes due to skin diseases or short stump length.
  • 9\. Those who have been judged by doctors to be unsuitable for participation in this study

Outcomes

Primary Outcomes

Not specified

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