Psychometric Study of the Spanish Version of Two Upper Limb Assessment Scales in Chronic Stroke

NCT05872191 | Enrolling By Invitation

• 1 other identifier: 2603789
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Change from baseline to re-test

Secondary Outcomes (10)

• Cognitive function: Montreal Cognitive Assessment (MoCA)

  The cohort group will be assessed at baseline

• Disability: Modified Rankin Scale (mRS)

  The cohort group will be assessed at baseline

• Stroke impact: Stroke Impact Scale v 3.0. (SIS)

  The cohort group will be assessed at baseline

• Muscle spasticity: Modified Ashworth Scale (MAS)

  The cohort group will be assessed at baseline

• Motor function: Fugl-Meyer Assessment- Upper Limb (FMA-UE)

  The cohort group will be assessed at baseline

Study Arms (1)

Upper extremity functional impairment due to chronic stroke

Spanish-native speakers with functional impairment of the upper extremity after stroke in chronic phase.

Other: No intervention

Interventions

No intervention OTHER

There is no intervention to be administered, only collection of data through various tests and questionnaires.

Upper extremity functional impairment due to chronic stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spanish-native speakers with functional impairment of the upper extremity after stroke in chronic phase.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

Location

Study Officials

• Maria-Arantzazu Ruescas-Nicolau, PT, PhD

  Department of Physiotherapy, University of Valencia (Spain)

  PRINCIPAL INVESTIGATOR

• M.Luz Sánchez-Sánchez, PT, PhD

  Department of Physiotherapy, University of Valencia (Spain)

  PRINCIPAL INVESTIGATOR

• Lirios Dueñas, PT, PhD

  Department of Physiotherapy, University of Valencia (Spain)

  STUDY DIRECTOR

• Monja Spotti, PT, MSc

  Faculty of Physiotherapy, University of Valencia (Spain)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiotherapy

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 24, 2023
• Study Start: December 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: June 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)