Chronic StrokeNCT05872191
Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
An observational study of Chronic Stroke, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this cross-sectional study is to translate and cross-culturally adapt to Spanish the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) and the Stroke Upper Limb Capacity Scale (SULCS) and to assess their psychometric properties in Spanish people with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Adult, Older adult
Study population: Spanish-native speakers with functional impairment of the upper extremity after stroke in chronic phase.
Who may be able to join
- Spanish-native speakers aged between 18 and 80 years with:
- Functional impairment of the upper extremity due to hemiparesis secondary to a stroke of ≥6 months of evolution
- Clinical stability
- Sufficient cognitive capacity to give consent to participate in the study and to understand and perform the assessment tests
Who cannot join
- Bilateral motor impairment
- Neurological impairment other than stroke (both central and peripheral nervous systems), musculoskeletal impairment (amputation, fracture, etc.) or disabling pain (Visual Analogue Scale score > 5) that may affect the performance of the tests
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Spanish-language Translation, Cross-cultural Adaption and Evaluation of the Psychometric Properties of Two Upper Limb Assessment Scales in People With Sequelae of Stroke in Chronic Phase
The purpose of this cross-sectional study is to translate and cross-culturally adapt to Spanish the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) and the Stroke Upper Limb Capacity Scale (SULCS) and to assess their psychometric properties in Spanish people with chronic stroke.
Read the detailed description
Stroke is the second cause of mortality and the first cause of acquired disability in Spain. In the coming years, due to the progressive ageing of the European population, the incidence of this disease is expected to increase. Current epidemiological studies estimate that one out of six people are likely to suffer a stroke during their lifetime in Spain.
The sequelae from stroke are very varied, with hemiparesis being one of the most commonly observed. The involvement of the upper limb is frequent in people with this sequela in the acute phase, affecting to 70% of them approximately, with the limitations that this can cause. It is therefore necessary to have instruments that quantify these functional changes and that must be sensitive, reliable and valid tools. These would allow treatment goals to be set, interventions to be planned and results to be recorded to determine effectiveness in an appropriate way.
Several scales are currently available to assess functional impairment of the upper extremity (UE) after stroke. For example, the Stroke Upper Limb Capacity Scale (SULCS) was developed with the idea of being a simple to use and unidimensional instrument to assess this population. It was the first scale that included simple functions items (minimal hand use) and highly demands manipulative items. Similarly, the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) quickly assesses quantity and quality of movement in the UE after stroke, and can be used to assess people with no muscle activation and still be sensitive to assess people with minimal motor impairment.
On the other hand, the linguistic and cultural adaptation of health assessment instruments is becoming necessary, given the increase of multinational research. Moreover, in countries with a multicultural population, this factor needs to be taken into account as it can have a direct effect on the measures recorded. The quality of healthcare is highly dependent on an accurate assessment process, which in turn will depend on an understanding of the cultural, linguistic and ethical context of each individual. Due to the increasingly diversified world population caused by globalisation, this need is increasing. The process of translating, adapting and validating a scale requires very rigorous planning and methodology so that a reliable and valid measure can be obtained for the target population.
The aim of this study is two-fold: first, to translate and cross-culturally adapt to Spanish the "Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)" and the "Stroke Upper Limb Capacity Scale (SULCS)"; and second to assess the psychometric properties of the Spanish versions of both scales in Spanish people with chronic stroke.
To cope with the study objectives, first, the translation and cross-culturally adaptation to Spanish of both scales was performed following the international recommendations. Next, a cross-sectional and psychometric study will be carried out. Participants will be assessed in two day visits (baseline and re-test), with no less than one week and no more than two weeks between them. In both visits, the two target scales will be performed. Additionally, in the first appointment, clinical, demographic and anthropometric data and cognitive function will be collected, and questionnaires and clinical tests will be carried out to study the reliability and validity of the target scales.
- Conditions
- Chronic Stroke
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention to be administered, only collection of data through various tests and questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Upper extremity functional impairment due to chronic stroke | Spanish-native speakers with functional impairment of the upper extremity after stroke in chronic phase. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of functional impairment of the hemiparetic upper extremity: Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES).
The MESUPES assesses the quality of movement performance of the hemiparetic arm and hand in people with stroke. It is a 17-item scale divided into two subscales: one for arm function (8 items with 6 response categories (0-5)) and other for hand function ("range of motion" 6 items; and "orientation during functional tasks" 3 items, with 3 response categories (0-2)). The maximum achievable score is 58 (MESUPES-Arm maximum score is 40; MESUPES-Hand maximum score is 18), with higher scores indicating better function
Measured: Change from baseline to re-test
Change of functional impairment of the hemiparetic upper extremity: Stroke Upper Limb Capacity Scale (SULCS)
The SULCS is a 10-item scale in which the ability to perform daily activities with the hemiparetic upper limb in increasing difficulty is assessed. The scoring is dichotomous (0, unable to perform the task; 1, able to perform the task). This results in a sum score ranging from 0 to 10 with higher scores indicating better functional capacity.
Measured: Change from baseline to re-test
Secondary outcomes (10)
Cognitive function: Montreal Cognitive Assessment (MoCA)
The MoCA is a screening instrument for detecting cognitive impairment that assesses multiple cognitive domains (attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation and orientation). The total score ranges from 0 to 30 points, with a score ≥ 26 considered to be normal.
Measured: The cohort group will be assessed at baseline
Disability: Modified Rankin Scale (mRS)
The mRS is a single-item measure of functional independence in which patients are asked about their overall health, their ease in carrying out ADLs (cooking, eating, dressing) and other factors about their life. The mRS result is reported on a 6-point scale (grade 0, indicating a lack of symptoms, and grade 5 indicating severe disability).
Measured: The cohort group will be assessed at baseline
Stroke impact: Stroke Impact Scale v 3.0. (SIS)
The SIS is a stroke-specific, self-report, health status measure. The SIS version 3.0 includes 59 items and assesses 8 domains: strength (four items), memory and thinking (seven items), emotion (nine items), communication (seven items), participation/role function (eight items), mobility (9 items), hand function (five items) and basic/instrumental activities of daily living (10 items). Each item is rated using a 5-point Likert-type scale (1 = an inability to complete the item; 5 = no difficulty experienced at all) and a global scores is calculated as a summative score of each domain, transformed into a 0-100 scale. It includes an extra question on the person´s perceived stroke recovery measured in the form of a visual analogue scale from 0-100.
Measured: The cohort group will be assessed at baseline
Muscle spasticity: Modified Ashworth Scale (MAS)
The MAS is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion. Each movement is rated on a 6-point scale, with higher scores indicating higher spasticity. The muscle tone of the shoulder, elbow and wrist will be assessed.
Measured: The cohort group will be assessed at baseline
Motor function: Fugl-Meyer Assessment- Upper Limb (FMA-UE)
The upper extremity motor domain of the Fugl-Meyer-Assessment will be used. It includes 33 items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand. Scoring is based on direct observation of performance, with each item scored on a 3-level ordinal scale (0 = unable to perform, 2 = near normal ability). The maximal achievable score is 66, being higher scores indicative of better motor function.
Measured: The cohort group will be assessed at baseline
Upper limb strength: Motricity Index (MI)
The MI is used to assess motor impairment after stroke. The upper extremity tests include shoulder abduction, elbow flexion and pinch grip. These three actions are scored each on a 33- point scale according to the MI instructions. A total upper extremity score is obtained by adding one to the sum of the three actions scores, with a maximum possible result of 100. Higher scores are indicative of less motor impairment.
Measured: The cohort group will be assessed at baseline
Manual dexterity: Box and Blocks Test (BBT)
The BBT is a performance based test of gross manual dexterity. It consists of moving as many wooden blocks as possible, one at a time, from one compartment of a partitioned box to the other, within 60 seconds. The test is scored by counting the number of blocks transferred (the higher the number of blocks transferred, the better the outcome).
Measured: The cohort group will be assessed one week after baseline
Digital dexterity: 9-Hole Peg Test (9HPT)
The 9HPT is a single-task performance based measure of digital dexterity. The test involves placing and removing nine pegs on a pegboard as quickly as possible, while timed. The quicker the pins are inserted and taken out, the better the outcome.
Measured: The cohort group will be assessed one week after baseline
Motor function: Action Research Arm Test (ARAT)
The ARAT is a 19-item test designed to assess upper extremity function and dexterity (grasp, grip, pinch and gross movement). Each item is scored on a 4-point ordinal scale (0 =no movement; 3= normal performance of the task), while the total score ranges from 0 to 57, with higher scores indicating better performance.
Measured: The cohort group will be assessed one week after baseline
Activities of daily living: Bimanual Hand Ability (ABILHAND)
The ABILHAND assesses the person's perceived difficulty in using the hand to perform manual activities in daily activities unaided. It is a 23-item self-report questionnaire than includes common bimanual activities (e.g. hammering a nail, wrapping gifts, cutting meat, buttoning a shirt, opening mail). Each task is scored on a 3-point scale (0=impossible, 1=difficult, 2=easy). Analysis of the answers is via a Rasch model of online analysis, which converts the raw scores into a linear measure (in logits). The higher the positive logits are, the better the person's ability.
Measured: The cohort group will be assessed one week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M Luz Sanchez, University of Valencia
- Investigators
- Maria-Arantzazu Ruescas-Nicolau, PT, PhD, Principal investigator, Department of Physiotherapy, University of Valencia (Spain)M.Luz Sánchez-Sánchez, PT, PhD, Principal investigator, Department of Physiotherapy, University of Valencia (Spain)Lirios Dueñas, PT, PhD, Study director, Department of Physiotherapy, University of Valencia (Spain)Monja Spotti, PT, MSc, Study chair, Faculty of Physiotherapy, University of Valencia (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872191
- Sponsor's protocol ID
- 2603789
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish-language Translation, Cross-cultural Adaption and Evaluation of the Psychometric Properties of Two Upper Limb Assessment Scales in People With Sequelae of Stroke in Chronic Phase
- ClinicalTrials.gov ID
- NCT05872191
- Acronym / sponsor ID
- 2603789
- Conditions
- Chronic Stroke
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 May 2023 (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.
The purpose of this cross-sectional study is to translate and cross-culturally adapt to Spanish the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) and the Stroke Upper Limb Capacity Scale (SULCS) and to assess their psychometric properties in Spanish people with chronic stroke.
Detailed description
Stroke is the second cause of mortality and the first cause of acquired disability in Spain. In the coming years, due to the progressive ageing of the European population, the incidence of this disease is expected to increase. Current epidemiological studies estimate that one out of six people are likely to suffer a stroke during their lifetime in Spain.
The sequelae from stroke are very varied, with hemiparesis being one of the most commonly observed. The involvement of the upper limb is frequent in people with this sequela in the acute phase, affecting to 70% of them approximately, with the limitations that this can cause. It is therefore necessary to have instruments that quantify these functional changes and that must be sensitive, reliable and valid tools. These would allow treatment goals to be set, interventions to be planned and results to be recorded to determine effectiveness in an appropriate way.
Several scales are currently available to assess functional impairment of the upper extremity (UE) after stroke. For example, the Stroke Upper Limb Capacity Scale (SULCS) was developed with the idea of being a simple to use and unidimensional instrument to assess this population. It was the first scale that included simple functions items (minimal hand use) and highly demands manipulative items. Similarly, the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) quickly assesses quantity and quality of movement in the UE after stroke, and can be used to assess people with no muscle activation and still be sensitive to assess people with minimal motor impairment.
On the other hand, the linguistic and cultural adaptation of health assessment instruments is becoming necessary, given the increase of multinational research. Moreover, in countries with a multicultural population, this factor needs to be taken into account as it can have a direct effect on the measures recorded. The quality of healthcare is highly dependent on an accurate assessment process, which in turn will depend on an understanding of the cultural, linguistic and ethical context of each individual. Due to the increasingly diversified world population caused by globalisation, this need is increasing. The process of translating, adapting and validating a scale requires very rigorous planning and methodology so that a reliable and valid measure can be obtained for the target population.
The aim of this study is two-fold: first, to translate and cross-culturally adapt to Spanish the "Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES)" and the "Stroke Upper Limb Capacity Scale (SULCS)"; and second to assess the psychometric properties of the Spanish versions of both scales in Spanish people with chronic stroke.
To cope with the study objectives, first, the translation and cross-culturally adaptation to Spanish of both scales was performed following the international recommendations. Next, a cross-sectional and psychometric study will be carried out. Participants will be assessed in two day visits (baseline and re-test), with no less than one week and no more than two weeks between them. In both visits, the two target scales will be performed. Additionally, in the first appointment, clinical, demographic and anthropometric data and cognitive function will be collected, and questionnaires and clinical tests will be carried out to study the reliability and validity of the target scales.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper extremity functional impairment due to chronic stroke | – | Other: No interventionSpanish-native speakers with functional impairment of the upper extremity after stroke in chronic phase. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Spanish-native speakers with functional impairment of the upper extremity after stroke in chronic phase.
Key inclusion criteria (4 listed)
- Functional impairment of the upper extremity due to hemiparesis secondary to a stroke of ≥6 months of evolution
- Clinical stability
- Sufficient cognitive capacity to give consent to participate in the study and to understand and perform the assessment tests
Key exclusion criteria (2 listed)
- Bilateral motor impairment
- Neurological impairment other than stroke (both central and peripheral nervous systems), musculoskeletal impairment (amputation, fracture, etc.) or disabling pain (Visual Analogue Scale score > 5) that may affect the performance of the tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention to be administered, only collection of data through various tests and questionnaires. | Other | Upper extremity functional impairment due to chronic stroke |
Primary outcome
Change of functional impairment of the hemiparetic upper extremity: Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES).
Time frame: Change from baseline to re-test
The MESUPES assesses the quality of movement performance of the hemiparetic arm and hand in people with stroke. It is a 17-item scale divided into two subscales: one for arm function (8 items with 6 response categories (0-5)) and other for hand function ("range of motion" 6 items; and "orientation during functional tasks" 3 items, with 3 response categories (0-2)). The maximum achievable score is 58 (MESUPES-Arm maximum score is 40; MESUPES-Hand maximum score is 18), with higher scores indicating better function
Change of functional impairment of the hemiparetic upper extremity: Stroke Upper Limb Capacity Scale (SULCS)
Time frame: Change from baseline to re-test
The SULCS is a 10-item scale in which the ability to perform daily activities with the hemiparetic upper limb in increasing difficulty is assessed. The scoring is dichotomous (0, unable to perform the task; 1, able to perform the task). This results in a sum score ranging from 0 to 10 with higher scores indicating better functional capacity.
10 secondary outcomes
Cognitive function: Montreal Cognitive Assessment (MoCA)
Time frame: The cohort group will be assessed at baseline
Disability: Modified Rankin Scale (mRS)
Time frame: The cohort group will be assessed at baseline
Stroke impact: Stroke Impact Scale v 3.0. (SIS)
Time frame: The cohort group will be assessed at baseline
Muscle spasticity: Modified Ashworth Scale (MAS)
Time frame: The cohort group will be assessed at baseline
Motor function: Fugl-Meyer Assessment- Upper Limb (FMA-UE)
Time frame: The cohort group will be assessed at baseline
Upper limb strength: Motricity Index (MI)
Time frame: The cohort group will be assessed at baseline
Manual dexterity: Box and Blocks Test (BBT)
Time frame: The cohort group will be assessed one week after baseline
Digital dexterity: 9-Hole Peg Test (9HPT)
Time frame: The cohort group will be assessed one week after baseline
Motor function: Action Research Arm Test (ARAT)
Time frame: The cohort group will be assessed one week after baseline
Activities of daily living: Bimanual Hand Ability (ABILHAND)
Time frame: The cohort group will be assessed one week after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Maria-Arantzazu Ruescas-Nicolau, PT, PhD principal investigator
Department of Physiotherapy, University of Valencia (Spain)
M.Luz Sánchez-Sánchez, PT, PhD principal investigator
Department of Physiotherapy, University of Valencia (Spain)
Lirios Dueñas, PT, PhD study director
Department of Physiotherapy, University of Valencia (Spain)
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 Chronic Stroke, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 15 Oct 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change of functional impairment of the hemiparetic upper extremity: Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES). (time frame: Change from baseline to re-test). 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 15 Oct 2026.