Observational study of a motion capture device (AKIRA) in patients with ALS

JRCT ID: jRCT1030230648

Registered date:22/02/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Amyotrophic Lateral Sclerosis
• Date of first enrollment: 04/01/2021
• Target sample size: 35
• Study type: Observational

Outcome(s)

• Primary Outcome: - Motion data using AKIRA

Secondary Outcome

- ALSFRS-R score
- % Forced vital capacity (%FVC)
- expiratory gas analysis
- Laboratory Tests (creatine kinase, creatinine, uric acid)
- InBody (body composition)

Key inclusion & exclusion criteria

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

Include criteria

1. Patients will be diagnosed with Definite ALS, Probable ALS, or Probable laboratory-supported ALS according to the El Escorial revised criteria for the diagnosis of ALS
2. Patients will be >= 20 years of age at the time the ICF is signed
3. Patients who can walk independently at a specified distance for video shooting
4. Patients who regularly visit the Yoshino Clinic about once a month
5. Patients who provided a signed and dated informed consent form (ICF) to participate in the study

Exclude criteria

1. Patients who have the presence of any clinically significant disease
2. Patients who are not eligible to participate in the study, as judged by the Investigator

Related Information

• Primary Sponsor: Hirai Manabu