NCT07508540

Validity and Responsiveness of the Fugl-Meyer Assessment in Subacute Stroke Patients

Validity and Responsiveness of the Fugl-Meyer Assessment in Individuals With Subacute Stroke

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective multicenter study evaluated the construct validity and responsiveness of the Fugl-Meyer Assessment (FMA) in individuals with subacute stroke undergoing inpatient rehabilitation. A total of over 100 participants were assessed at admission and discharge using FMA alongside established clinical measures and patient-reported anchors.

Detailed description

This study aims to evaluate the construct validity and responsiveness of the Fugl-Meyer Assessment (FMA) in individuals with subacute stroke undergoing inpatient rehabilitation. The FMA is widely used to assess motor impairment after stroke; however, evidence on its responsiveness, particularly in subacute populations, remains limited. Participants with post-stroke hemiparesis are assessed at admission and discharge using the FMA, along with other clinical outcome measures. Construct validity is examined by testing predefined hypotheses on the association between FMA scores and measures of muscle strength and functional independence. Responsiveness is evaluated using both anchor-based and distribution-based approaches, including patient-reported and performance-based external criteria. The study focuses on both upper and lower limb subscales of the FMA. External anchors include a Global Rating of Change scale and functional ambulation measures, allowing a multidimensional interpretation of motor recovery. The ability of the FMA to detect clinically meaningful changes over time is quantified through receiver operating characteristic analyses and estimation of minimal clinically important differences. This study will contribute to a better understanding of the measurement properties of the FMA in the subacute phase of stroke recovery and support its use in clinical practice and research settings.

Conditions

• Stroke

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-20
• Completion: 2026-01-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: Italy