StrokeFMA_val_respNCT07508540
Validity and Responsiveness of the Fugl-Meyer Assessment in Subacute Stroke Patients
An observational study of Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 1 Jan 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Responsiveness of the Fugl-Meyer Assessment in Individuals With Subacute Stroke
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, Measurement Properties
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 3 weeks
Secondary outcomes (8)
Modified Barthel Index
A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks.
Measured: Baseline
Modified Barthel Index
A measure of independence in activities of daily living, assessing the patient's functional ability in everyday tasks.
Measured: after 3 weeks
Motricity Index
A clinical scale used to assess muscle strength in upper and lower limbs following stroke.
Measured: Baseline
Motricity Index
A clinical scale used to assess muscle strength in upper and lower limbs following stroke.
Measured: after 3 weeks
Functional Ambulation Category
A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation.
Measured: Baseline
Functional Ambulation Category
A clinician-rated scale that evaluates walking ability and level of assistance required for ambulation.
Measured: 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."
Measured: after 3 weeks
Clinical Instability Scale (CIS)
A scale assessing clinical stability based on vital parameters, used to determine eligibility and safety for participation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jul 2023
- Primary completion20 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Cecchi, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508540
- Sponsor's protocol ID
- FMA_validity_responsivness
- Acronym
- FMA_val_resp
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Responsiveness of the Fugl-Meyer Assessment in Individuals With Subacute Stroke
- ClinicalTrials.gov ID
- NCT07508540
- Acronym / sponsor ID
- FMA_val_resp / FMA_validity_responsivness
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, Measurement Properties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
Modified Barthel Index
Time frame: Baseline
Modified Barthel Index
Time frame: after 3 weeks
Motricity Index
Time frame: Baseline
Motricity Index
Time frame: after 3 weeks
Functional Ambulation Category
Time frame: Baseline
Functional Ambulation Category
Time frame: after 3 weeks
Global Rating of Change (GROC)
Time frame: after 3 weeks
Clinical Instability Scale (CIS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. 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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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assessment (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.