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NCT Number: NCT07508540

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Don Gnocchi

Florence, 50143, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Fugl Meyer Assessment

    Time frame: Baseline

    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.

  2. Fugl-Meyer Assessment

    Time frame: after 3 weeks

    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.

Secondary outcomes

  1. Modified Barthel Index

    Time frame: Baseline

    A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks.

  2. Modified Barthel Index

    Time frame: after 3 weeks

    A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks.

  3. Motricity Index

    Time frame: Baseline

    A clinical scale used to assess muscle strength in upper and lower limbs following stroke.

  4. Motricity Index

    Time frame: after 3 weeks

    A clinical scale used to assess muscle strength in upper and lower limbs following stroke.

  5. Functional Ambulation Category

    Time frame: Baseline

    A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation.

  6. Functional Ambulation Category

    Time frame: after 3 weeks

    A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation.

  7. Global Rating of Change (GROC)

    Time frame: after 3 weeks

    A patient-reported scale measuring perceived change in motor function compared to baseline, rated on a 7-point scale from "much worse" to "much better."

  8. Clinical Instability Scale (CIS)

    Time frame: Baseline

    A scale assessing clinical stability based on vital parameters, used to determine eligibility and safety for participation.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Acronym: FMA_val_resp

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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