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

NCT07508540 | Completed DMC

• 1 other identifier: FMA_validity_responsivness
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

stroke; rehabilitation; Measurement Properties

Outcome Measures

Primary Outcomes (2)

• Fugl Meyer Assessment

  A stroke-specific scale evaluating motor function, sensory function, joint range of motion, and pain in upper and lower limbs. It provides detailed assessment of motor impairment severity.

  Baseline

• Fugl-Meyer Assessment

  A stroke-specific scale evaluating motor function, sensory function, joint range of motion, and pain in upper and lower limbs. It provides detailed assessment of motor impairment severity.

  after 3 weeks

Secondary Outcomes (8)

• Modified Barthel Index

  Baseline

• Modified Barthel Index

  after 3 weeks

• Motricity Index

  Baseline

• Motricity Index

  after 3 weeks

• Functional Ambulation Category

  Baseline

Study Arms (1)

Subacute Stroke Cohort

Participants with subacute stroke undergoing inpatient rehabilitation. All participants are assessed at admission and discharge using the Fugl-Meyer Assessment and additional clinical outcome measures to evaluate motor function, construct validity, and responsiveness over time. No intervention-based group allocation is performed, as this is an observational study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult individuals with a diagnosis of stroke and resulting hemiparesis, referred from acute care hospitals to inpatient rehabilitation units. Participants are in the subacute phase of stroke recovery and present with residual motor impairment affecting upper and/or lower limb function, as well as limitations in activities of daily living. Patients are consecutively recruited from specialized neurorehabilitation centers providing intensive, multidisciplinary rehabilitation programs. The population reflects a typical clinical sample of individuals undergoing inpatient rehabilitation after stroke, with a wide range of motor impairment severity and functional limitations.

You may qualify if:

• Age ≥ 18 years
• Diagnosis of stroke with resulting hemiparesis
• stroke outcomes with the presence of sensorimotor impairment affecting the upper and/or lower limb
• Admission to inpatient rehabilitation in the subacute phase of stroke
• Ability and willingness to provide informed consent

You may not qualify if:

• Severe or uncorrected visual or hearing impairments interfering with assessment
• Cognitive or language impairments preventing understanding or execution of study procedures
• Clinical instability, defined as a Clinical Instability Scale (CIS) score \> 0
• Any medical condition preventing safe participation in rehabilitation or assessments

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Gnocchi

Florence, Florence, 50143, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 2, 2026
• Study Start: July 1, 2023
• Primary Completion: December 20, 2025
• Study Completion: January 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)