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

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 - Safety and efficacy of the sj-HAL on early recovery of knee extension after surgery in patients with osteoarthritis of the knee

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017012

Enrollment

Registered

2015-04-01

Start date

2015-04-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis of the knee

Interventions

Participants will do a trial fitting of HAL before knee surgery and then conduct exercises with HAL 2 or 3 times a week for about 3 weeks after knee surgery.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must satisfy the following conditions for inclusion: 1. Patients who can be hospitalized continuously along the test schedule. 2. Understand the explanation of the experiment and express consent or refusal. 3. Have a body shape that can be fitted into HAL. 4. Be able to undergo usual physical therapy and occupational therapy. 5. Patients whose knee is straightened worse at 5 to 7 days after surgery rather than at the completion of surgery under anesthesia.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTomokazu Yoshioka

University of Tsukuba Department of Orthopaedics Surgery, Faculty of Medicine

yoshioka@md.tsukuba.ac.jp029-853-3219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026