Outcome survey of " HAL for Medical Use (Lower Limb Type)"

Longterm outcome survey of "HAL for Medical Use (Lower Limb Type)" - Use result survey of " HAL for Medical Use (Lower Limb Type)"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1092220301

Enrollment

180

Registered

2017-07-03

Start date

2017-07-05

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

The neuromuscular diseases including spinal muscular atrophy, spinal bulbar muscular atrophy, muscular dystrophy, Charcot-Marie Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, and amyotrophic lateral sclerosis

Interventions

Intervention type:DEVICE Name of intervention:Cybernic treatment using "HAL for Medical Use (Lower Limb Type)" Dose form / Japanese Medical Device Nomenclature:DEVICE " HAL for Medical Use (Lower Limb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria must be in accordance with the approved label of "HAL for Medical Use (Lower Limb Type)" Briefly, the patients of the neuromuscular diseases including spinal muscular atrophy, spinal bulbar muscular atrophy, muscular dystrophy, Charcot-Marie Tooth disease, distal myopathy, sporadic inclusion body myositis, congenital myopathy, and amyotrophic lateral sclerosis who have gait disorder. Body weight ranges from 40 to 100 kg. Body length range approximately from 150 to 190 cm. Lower limb length must be fit to the device length. The patients who are able to wear "HAL for Medical Use (Lower Limb Type)".

Exclusion criteria

Exclusion criteria: In the case that patient's length and shape are not fit to "HAL for Medical Use (Lower Limb Type)". In the case that patient is not allowed to stand and/or walk with "HAL for Medical Use (Lower Limb Type)". In the case that electrodes are not allowed to be put on the patient's skin because of the patient's skin disease.

Design outcomes

Primary

Measure	Time frame
2-min walk test (Distance)	—

Secondary

Measure	Time frame
10 m walk test (Time, Steps) Manual Muscle Test (MMT) Assessment of activities of daily living (ADL) (Barthel index) Quality of life (QOL)(EQ-5D-5L index, EQ-5D-5L VAS, Patient Reported Outcome (Japanese Version of the Decision Regret Scale), Free comment) serum Creatine Kinase	—

Countries

Japan

Contacts

Public ContactMakoto Nihei

CYBERDYNE, INC.

nihei_makoto@cyberdyne.jp+81-29-869-8450

Outcome results

None listed

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