Stroke
Conditions
Keywords
stroke, rehabilitation, Measurement Properties
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.
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.
Interventions
None listed
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Assessment | 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. |
| Fugl-Meyer Assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| Modified Barthel Index | Baseline | A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks. |
| Motricity Index | Baseline | A clinical scale used to assess muscle strength in upper and lower limbs following stroke. |
| Functional Ambulation Category | Baseline | A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation. |
| Global Rating of Change (GROC) | 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." |
| Clinical Instability Scale (CIS) | Baseline | A scale assessing clinical stability based on vital parameters, used to determine eligibility and safety for participation. |
Countries
Italy
Outcome results
None listed