Clinical trial NCT05872191: Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Stroke
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spanish-native speakers with functional impairment of the upper extremity after stroke in chronic phase.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of functional impairment of the hemiparetic upper extremity: Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES).
timeFrame: Change from baseline to re-test
measure: Change of functional impairment of the hemiparetic upper extremity: Stroke Upper Limb Capacity Scale (SULCS)
timeFrame: Change from baseline to re-test
Secondary outcomes:
measure: Cognitive function: Montreal Cognitive Assessment (MoCA)
timeFrame: The cohort group will be assessed at baseline
measure: Disability: Modified Rankin Scale (mRS)
timeFrame: The cohort group will be assessed at baseline
measure: Stroke impact: Stroke Impact Scale v 3.0. (SIS)
timeFrame: The cohort group will be assessed at baseline
measure: Muscle spasticity: Modified Ashworth Scale (MAS)
timeFrame: The cohort group will be assessed at baseline
measure: Motor function: Fugl-Meyer Assessment- Upper Limb (FMA-UE)
timeFrame: The cohort group will be assessed at baseline
measure: Upper limb strength: Motricity Index (MI)
timeFrame: The cohort group will be assessed at baseline
measure: Manual dexterity: Box and Blocks Test (BBT)
timeFrame: The cohort group will be assessed one week after baseline
measure: Digital dexterity: 9-Hole Peg Test (9HPT)
timeFrame: The cohort group will be assessed one week after baseline
measure: Motor function: Action Research Arm Test (ARAT)
timeFrame: The cohort group will be assessed one week after baseline
measure: Activities of daily living: Bimanual Hand Ability (ABILHAND)
timeFrame: The cohort group will be assessed one week after baseline
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Department of Physiotherapy, University of Valencia (Spain)
name: Maria-Arantzazu Ruescas-Nicolau, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physiotherapy, University of Valencia (Spain)
name: M.Luz Sánchez-Sánchez, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physiotherapy, University of Valencia (Spain)
name: Lirios Dueñas, PT, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Physiotherapy, University of Valencia (Spain)
name: Monja Spotti, PT, MSc
role: STUDY_CHAIR
References: