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

JRCT ID: jRCTs032240462

Registered date:05/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hereditary ATTR amyloidosis
• Date of first enrollment: 05/11/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Gait training with HAL

Outcome(s)

• Primary Outcome: Change in 10-m walking time between pre and post-robot rehabilitation.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Matsushima Akira
• Source(s) of Monetary Support: Japan Society for the Promotion of Science