Adults With Acquired Brain InjuryF-EmNSA-MINCT07613541
Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale for the Lower Limb in Acquired Brain Injury Into French
An observational study of Adults With Acquired Brain Injury, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults With Acquired Brain Injury
- What is being tested?
- French Erasmus modified Nottingham Sensory Assessment scale, Self-Reported Somatosensory Sensations questionnaire and Sensitive digital scale
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with an acquired brain injury
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service des Explorations Fonctionnelles Physiologiques (Pôle 32) - Hôpital Purpan, Place du Dr Baylac
Toulouse, Occitanie, 31059
David GASQ, Professor, +33561777318, gasq.d@chu-toulouse.fr
About this study
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.
- Conditions
- Adults With Acquired Brain Injury
- Being tested
- French Erasmus modified Nottingham Sensory Assessment scale, Self-Reported Somatosensory Sensations questionnaire, Sensitive digital scale
- Keywords
- Somatosensory deficits, Somesthesis, Somatosensory assessment, Stroke, Erasmus modified Nottingham Sensory Assessment, Somatosensation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
French Erasmus modified Nottingham Sensory Assessment scaleOther
Clinical evaluation of somatosensation of the lower limbs in French
Self-Reported Somatosensory Sensations questionnaireOther
Somatosensory sensation data
Sensitive digital scaleOther
Sensitive digital assessment data
| Study group | Role | What they receive |
|---|---|---|
| Brain injury patients | Acquired brain injury patients with a score of 4 or higher on the Aphasia Severity Scale and a score of 1 or lower on the Anosognosia Assessment Receives: Other: French Erasmus modified Nottingham Sensory Assessment scale; Other: Self-Reported Somatosensory Sensations questionnaire; Other: Sensitive digital scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reproducibility
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).
Measured: Day 0 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613541
- Sponsor's protocol ID
- RC31/26/0019
- Other IDs
- 2026-A00175-46
- Acronym
- F-EmNSA-MI
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale for the Lower Limb in Acquired Brain Injury Into French
- ClinicalTrials.gov ID
- NCT07613541
- Acronym / sponsor ID
- F-EmNSA-MI / RC31/26/0019
- Conditions
- Adults With Acquired Brain Injury
- Keywords
- Somatosensory deficits, Somesthesis, Somatosensory assessment, Stroke, Erasmus modified Nottingham Sensory Assessment, Somatosensation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain injury patients | – | Other: French Erasmus modified Nottingham Sensory Assessment scale, Other: Self-Reported Somatosensory Sensations questionnaire, Other: Sensitive digital scaleAcquired brain injury patients with a score of 4 or higher on the Aphasia Severity Scale and a score of 1 or lower on the Anosognosia Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with an acquired brain injury
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| French Erasmus modified Nottingham Sensory Assessment scaleClinical evaluation of somatosensation of the lower limbs in French | Other | Brain injury patients |
| Self-Reported Somatosensory Sensations questionnaireSomatosensory sensation data | Other | Brain injury patients |
| Sensitive digital scaleSensitive digital assessment data | Other | Brain injury patients |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults With Acquired Brain Injury, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David GASQ, Professor (+33561777318, gasq.d@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reproducibility (time frame: Day 0 and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.