Evaluation of the usefulness of the Japanese version of self-administered ALSFRS-R in ALS patients

JRCT ID: jRCT1070230112

Registered date:30/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Amyotrophic lateral sclesoris (ALS)
• Date of first enrollment: 30/01/2024
• Target sample size: 60
• Study type: Observational

Outcome(s)

• Primary Outcome: Correlation between the ALSFRS-R score (total score of 12 items) as answered by the patients themselves and the ALSFRS-R score (total score of 12 items) as assessed by healthcare professionals.

Secondary Outcome

1) Correlation between the ALSFRS-R score answered by the patients themselves and the ALSFRS-R score assessed by healthcare professionals (by item)
2) Correlation between ALSFRS-R score as assessed by caregivers and ALSFRS-R score as assessed by healthcare professionals (total of 12 items)
3) Correlation between ALSFRS-R score as assessed by caregivers and ALSFRS-R score as assessed by healthcare professionals (by item)
4) Correlation between the amount of change over time in the ALSFRS-R as assessed by the patient themselves and the amount of change over time in the ALSFRS-R score as assessed by healthcare professionals (12-item total score)
5) Correlation between the amount of change over time in the ALSFRS-R as assessed by caregivers and the amount of change over time in the ALSFRS-R score as assessed by healthcare professionals (total score of 12 items)
6) Correlation between item-specific ALSFRS-R scores as answered by the patients themselves and neurological findings (manual muscle strength tests for the items of limb motor function, and pulmonary function test results for the items of respiratory function)
7) Correlation between item-specific ALSFRS-R scores assessed by caregivers and neurological findings (manual muscle strength tests for items of limb motor function, and pulmonary function test results for items of respiratory function)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients diagnosed with amyotrophic lateral sclerosis
2. Patients who fully understand the research plan and are able to give their own consent
3. Patients aged 18 years or older at the time of obtaining informed consent

Exclude criteria

1. Patients who are unable to operate electronic terminals due to either cognitive decline, cognitive dysfunction, or visual impairment
2. Patients with fever
3. Patients with neurological or psychiatric complications other than amyotrophic lateral sclerosis
4. Patients who the investigator considers to be unsuitable as research subjects

Related Information

• Primary Sponsor: Isobe Noriko