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NCT Number: NCT07613541

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

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.

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Key information

Conditions

Adults With Acquired Brain Injury Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service des Explorations Fonctionnelles Physiologiques (Pôle 32) - Hôpital Purpan, Place du Dr Baylac

Toulouse, Occitanie, 31059, France

Location contact

David GASQ, Professor

CONTACT

[email protected]

+33561777318

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

French Erasmus modified Nottingham Sensory Assessment scale

Other

Clinical evaluation of somatosensation of the lower limbs in French

Self-Reported Somatosensory Sensations questionnaire

Other

Somatosensory sensation data

Sensitive digital scale

Other

Sensitive digital assessment data

Primary outcomes

Inter-rater reproducibility

Time frame: Day 0 and day 7

The intraclass correlation coefficient will be evaluated based on the results of the EmNSAMI measurements, obtained by 2 independent evaluators (E1 and E2 or E3; therapists with expertise in the evaluation of patients with acquired brain injury).

Study contacts

Contact information is provided by the study sponsor or research team.

David GASQ, Professor

CONTACT

[email protected]

+33561777318

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: F-EmNSA-MI

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 29, 2026
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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