Safety and efficacy of the single joint type of Hybrid Assistive Limb (sj-HAL), a device for any arm and knee joints and specialized in intensive training, on early recovery of knee extension after surgery in patients with osteoarthritis of the knee
Phase 1
- Conditions
- osteoarthritis of the knee
- Registration Number
- JPRN-UMIN000017012
- Lead Sponsor
- niversity of Tsukuba Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system. 2. Patients has a complication, which can disturb the treatment using HAL. 3. The biological electrode for HAL can not be affixed to patient's skin due to the skin disease. 4. Patients who take part in other trials within last 12 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Vital signs (blood pressure, pulse rate and oxyhemoglobin saturation measured by pulse oximetry) 2. Radiological evaluation (X-ray) 3. Satisfaction with the assistance in mobility provided by HAL 4. Amount of time needed to put on and take off the apparatus 5. Adverse events
- Secondary Outcome Measures
Name Time Method 1. Active and passive range of motion of the knee 2. Japanese orthopaedic association score for osteoarthritic knees (JOA knee score) 3. Japanese knee osteoarthritis measure (JKOM) 4. Muscle strengh of quadriceps femoris 5. 10-m walking