Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale f… (NCT07613541) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale for the Lower Limb in Acquired Brain Injury Into French
France50 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.