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Clinical Trials/NCT05872191
NCT05872191
Enrolling By Invitation
Not Applicable

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

University of Valencia1 site in 1 country50 target enrollmentDecember 1, 2023
ConditionsChronic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
University of Valencia
Enrollment
50
Locations
1
Primary Endpoint
Change of functional impairment of the hemiparetic upper extremity: Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES).
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
June 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

M Luz Sanchez

Associate Professor of Physiotherapy

University of Valencia

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Disability: Modified Rankin Scale (mRS)(The cohort group will be assessed at baseline)
  • Manual dexterity: Box and Blocks Test (BBT)(The cohort group will be assessed one week after baseline)
  • Stroke impact: Stroke Impact Scale v 3.0. (SIS)(The cohort group will be assessed at baseline)
  • Activities of daily living: Bimanual Hand Ability (ABILHAND)(The cohort group will be assessed one week after baseline)
  • Motor function: Fugl-Meyer Assessment- Upper Limb (FMA-UE)(The cohort group will be assessed at baseline)
  • Cognitive function: Montreal Cognitive Assessment (MoCA)(The cohort group will be assessed at baseline)
  • Muscle spasticity: Modified Ashworth Scale (MAS)(The cohort group will be assessed at baseline)
  • Upper limb strength: Motricity Index (MI)(The cohort group will be assessed at baseline)
  • Digital dexterity: 9-Hole Peg Test (9HPT)(The cohort group will be assessed one week after baseline)
  • Motor function: Action Research Arm Test (ARAT)(The cohort group will be assessed one week after baseline)

Study Sites (1)

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