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

Evaluation of the usefulness of the Japanese version of self-administered ALS Functional Rating Scale -Revised (ePRO version) in patients with amyotrophic lateral sclerosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1070230112

Enrollment

Registered

2024-01-30

Start date

2024-01-30

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

Amyotrophic lateral sclesoris (ALS) ALS, ALSFRS-R, PRO

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

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Contacts

Public ContactYuko Kobayakawa

Kyushu University Hospital

shinkein@med.kyushu-u.ac.jp+81-92-642-5340

Outcome results