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Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS

Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS - Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002969
Enrollment
80
Registered
2010-01-04
Start date
2010-01-01
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

Musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS

Interventions

Participants will do a trial fitting of HAL 2 or 3 times a week for 2 weeks and then conduct exercises with HAL 2 or 3 times a week for 8 weeks.

Sponsors

University of Tsukuba
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects must satisfy the following conditions for inclusion: 1. Need assistance from another person or aid in at least one of the following daily activities; standing up, sitting down, and walking. 2. Understand the explanation of the experiment and express consent or refusal. Informed consent will also be obtained from the patient's guardian if the patient is younger than 20 years. 3. Have a body shape that can be fitted into HAL. 4. Be able to undergo usual physical therapy and occupational therapy.

Exclusion criteria

Exclusion criteria: The following patients will be excluded: 1. Patients with inadequately treated cardiovascular disorders. 2. Patients with inadequately treated respiratory disorders. 3. Patients with intellectual impairments that interfere with their understanding of the explanetion of the experiment or instructions they need to follow. 4. Patients with moderate to severe articular problem, including contracture in the lower extremities. 5. Patients with a moderate to severe degree of involuntary movements, ataxia, or impairment of postural reflex in the trunk or lower extremities. 6. Patients with severe spasticity in the lower extremities.

Design outcomes

Primary

MeasureTime frame
Balancing and walking ability will be evaluated with the Functional Balance Scale, the 10-m walking test, and the 3-m timed up and go test.

Secondary

MeasureTime frame
1. Vital signs (heart rate and blood pressure) 2. Severity of the disorder 3. Activities of daily living (Barthel Index) 4. Health-related quality of life (SF-36) 5. Profile of mood states (POMS) 6. Range of motion of the joints in the lower extremities 7. Muscle strength of the major muscles in the lower extremities 8. Rate of perceived exertion (Borg Scale) 9. Muscle action potentials 10. Satisfaction with the assistance in mobility provided by HAL 11. Amount of time needed to put on and take off the apparatus 12. Sabilometry 13. Functional MRI images of the brain 14. Three-dimensional motion analysis 15. Adverse events

Countries

Japan

Contacts

Public ContactKiyoshi Eguchi

Faculty of Medicine, University of Tsukuba Division of Clinical Medicine

kyeguchi-tkb@umin.ac.jp029-853-3795

Outcome results

None listed

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