Reliability, Validity, and Responsibility of Patient Reported Outcome of Spasticity

Reliability, Validity, and Responsibility of Patient Reported Outcome of Spasticity - Reliability, Validity, and Responsibility of PRO of Spasticity

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051930

Enrollment

100

Registered

2023-08-18

Start date

2023-08-07

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

central motor paralysis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years of age or older and less than 80 years of age; stable general condition of motor paralysis due to unilateral lesion; no evidence of cognitive decline or severe aphasia and able to understand the study; written consent based on the patient's free will obtained after a thorough explanation of the study; ability to go to the hospital and be hospitalized according to the study schedule.

Exclusion criteria

Exclusion criteria: Persons with severe dementia, persons with severe psychiatric complications, and others deemed unsuitable by the physician.

Design outcomes

Primary

Measure	Time frame
Reliability: results of ArmA and LegA assessments on admission and the next day in patients at admission Validation: correlation with modified Ashworth scale (MAS), modified Tardieu scale (MTS), Motor Activity Log-14 (MAL-14), and Fugl-Meyer Assessment (FMA) Responsibility: changes in functional assessment results at admission and discharge for inpatients, and before botulinum treatment and at outpatient visits 4 to 8 weeks later for outpatients	—

Measure

Time frame

Reliability: results of ArmA and LegA assessments on admission and the next day in patients at admission Validation: correlation with modified Ashworth scale (MAS), modified Tardieu scale (MTS), Motor Activity Log-14 (MAL-14), and Fugl-Meyer Assessment (FMA) Responsibility: changes in functional assessment results at admission and discharge for inpatients, and before botulinum treatment and at outpatient visits 4 to 8 weeks later for outpatients

—

Secondary

Measure	Time frame
MAS, MTS, MAL-14, FMA	—

Countries

Japan

Contacts

Public ContactTakayuki Kamimoto

Keio University School of Medicine Department of Rehabilitation Medicine

rw.mssl.720@gmail.com0333531211

Outcome results