Effects of using medical robots on amputees

JRCT ID: jRCTs062200031

Registered date:01/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Those who plan to have a thigh or lower leg amputation
• Date of first enrollment: 07/10/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Perform HAL pre- and post-operative walking exercises on the subject. The frequency of intervention is at least once before surgery, 5 days a week after surgery, and 30 minutes once a day for 8 weeks.

Outcome(s)

• Primary Outcome: 2 minutes walking distance
• Secondary Outcome: Both lower limb muscle strength, skeletal muscle mass, sensory disturbance, range of motion, Berg balance scale, Short Physical Performance Battery (SPPB), 2-minute walking distance, Timed Up and Go Test, maximum oxygen uptake, Locomo 25, EMG, Gait, BI (Barthel Index), FIM (Functional Independence Measure), FAI (Frenchay Activities Index), SF36, Health Utilities Index, Euro-Qol-5D-5L (QALY for quality adjusted life), Long-term care insurance certification, General Self-Efficacy Scale, WHODAS2.0, Locomotor Capabilities Index(LCI),Prosthetic Evaluation Questionnaire Japan(PEQJ)

Key inclusion & exclusion criteria

• Age minimum: >= 16age 00month 00weeks old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ushio Kai