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.
Investigators
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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