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.
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.
Study Type
OBSERVATIONAL
Enrollment
135
IRCCS Fondazione Don Gnocchi
Florence, Florence, Italy
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.
Time frame: 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.
Time frame: after 3 weeks
Modified Barthel Index
A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks.
Time frame: Baseline
Modified Barthel Index
A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks.
Time frame: after 3 weeks
Motricity Index
A clinical scale used to assess muscle strength in upper and lower limbs following stroke.
Time frame: Baseline
Motricity Index
A clinical scale used to assess muscle strength in upper and lower limbs following stroke.
Time frame: after 3 weeks
Functional Ambulation Category
A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation.
Time frame: Baseline
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Functional Ambulation Category
A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation.
Time frame: after 3 weeks
Global Rating of Change (GROC)
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."
Time frame: after 3 weeks
Clinical Instability Scale (CIS)
A scale assessing clinical stability based on vital parameters, used to determine eligibility and safety for participation.
Time frame: Baseline