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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Barthel Index | A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks. | Baseline |
| Modified Barthel Index | A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Gnocchi | Florence | Florence | 50143 | Italy |
Individual participant data (IPD) will not be shared due to privacy and ethical restrictions related to sensitive clinical data. Data are stored in a secure environment and are accessible only to authorized study personnel.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| after 3 weeks |
| Motricity Index | A clinical scale used to assess muscle strength in upper and lower limbs following stroke. | Baseline |
| Motricity Index | A clinical scale used to assess muscle strength in upper and lower limbs following stroke. | after 3 weeks |
| Functional Ambulation Category | A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation. | Baseline |
| Functional Ambulation Category | A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation. | 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." | after 3 weeks |
| Clinical Instability Scale (CIS) | A scale assessing clinical stability based on vital parameters, used to determine eligibility and safety for participation. | Baseline |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |