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Not yet recruiting NCT07613541

Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale for the Lower Limb in Acquired Brain Injury Into French

Observational Adults With Acquired Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: French Erasmus modified Nottingham Sensory Assessment scale, Self-Reported Somatosensory Sensations questionnaire, Sensitive digital scale.
Who it may be relevant to
Registry conditions: Adults With Acquired Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

There is a lack of validated and standardized tools in French for assessing somatosensory perception in adults with brain injuries. The only validated tool in French is the Fugl-Meyer Scale for Sensorimotor Recovery after a Stroke, which assesses only light touch sensitivity in two areas of the arm and leg, as well as proprioception for eight joints. The Erasmus Modified Nottingham Sensory Assessment (EmNSA) offers a detailed assessment of limb somatosensory perception in English. The upper limb (UL) version has been validated in French. The lower limb component remains to be translated and culturally adapted. This cross-cultural translation and adaptation project aims to validate this tool for a comprehensive clinical assessment of somatosensory deficits, applicable in both clinical practice and research. The project aims to validate the study of the metrological qualities (validity and reliability of the scale) of the French version of the EmNSA for the lower limbs.

Interventions

  • Other French Erasmus modified Nottingham Sensory Assessment scale
    Clinical evaluation of somatosensation of the lower limbs in French
  • Other Self-Reported Somatosensory Sensations questionnaire
    Somatosensory sensation data
  • Other Sensitive digital scale
    Sensitive digital assessment data

Primary outcome measures

  • Inter-rater reproducibility [Time frame: Day 0 and day 7]

Eligibility criteria

Inclusion criteria

  • Patient with an acquired brain injury attested by brain imaging (CT scan or MRI) of more than seven days
  • Sufficient comprehension ability to participate in the study
  • Patients receiving care in the routine care pathway, as part of rehabilitation or functional assessments available for 6 weeks minimum and 12 weeks maximum
  • Ability to hold attention for at least 30 minutes
  • Aphasia Severity Scale score of 4 or higher
  • Anosognosia Assessment (from the Unilateral Neglect Assessment Battery) score of 1 or lower

Exclusion criteria

  • Patient with peripheral neurological pathology
  • Severe communication disorders with a score of less than 4 on the Aphasia Severity Scale
  • Anosognosia Assessment (from the Unilateral Neglect Assessment Battery) score of 2 or higher
  • Major attention disorders making it impossible to take stock
  • Patient under guardianship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service des Explorations Fonctionnelles Physiologiques (Pôle 32) - Hôpital Purpan, Place d — Toulouse

Identifiers

NCT: NCT07613541 · RC31/26/0019 · 2026-A00175-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗