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Evaluation of the rehabilitation effect of HAL on patients with hereditary ATTR amyloidosis

An uncontrolled, exploratory clinical trial to evaluate the rehabilitative effects of HAL on patients with hereditary ATTR amyloidosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032240462
Enrollment
20
Registered
2024-11-05
Start date
2024-12-09
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

hereditary ATTR amyloidosis ATTR, Hereditary Amyloidosis

Interventions

Gait training with HAL
gait training, robot rehabilitation

Sponsors

Matsushima Akira
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: i) Patients who are 20 years or older when obtaining consent. ii) Patients with a confirmed diagnosis of ATTRv amyloidosis by genetic testing. iii) Patients who can safely wear the HAL for medical use (lower limb type). (height range: about 150 to 190 cm, weight range: 40 to 100kg) iv) Patients who can walk 10 meters independently with or without a walking aid. v) Patients who can continue to be hospitalized according to the schedule during the study period. vi) Patients who have received a enough explanation, and who have given written consent for the study with an understanding of the study.

Exclusion criteria

Exclusion criteria: i) Patients who have difficulty wearing HAL due to physical factors or coexisting orthopedic diseases. ii) Patients with bleeding tendencies or skin diseases that may interfere with gait training while wearing HAL. iii) Patients who have experienced a decline in gait ability in the three months before registration, leading to changes in their daily activities. iv) Patients who are deemed inappropriate as research subjects by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Change in 10-m walking time between pre and post-robot rehabilitation.

Secondary

MeasureTime frame
Change in 2-minute walking distance between pre and post-robot rehabilitation. Change in Neuropathy Impairment between pre and post-robot rehabilitation. Patient-reported outcomes.

Contacts

Public ContactAkira Matsushima

Shinshu University Hospital

matsuaki@shinshu-u.ac.jp+81-263-37-2673

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026