Clinical trial NCT05650398: Changes in Tactile Perception in People With Segmental Exclusion Syndrome
Official title: Changes in Tactile Perception in People With Segmental Exclusion Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Limb Exclusion Syndrom
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of adults with a segmental exclusion of a finger more than 3 months after the initial injury. In order to study sensitivity disorders related to the exclusion, we decided to include only people who had no pathology that could have an impact on sensitivity and who had no truncal nerve damage at the time of the initial injury.

Brief summary: Segmental exclusion syndrome is characterised by the non-use or under-use of a limb segment, most oftenly reported in the distal part, following an injury, without affecting the central nervous system. This syndrome has an important negative impact on the daily life of affected subjects; however, it remains poorly studied, particularly in terms of pathophysiology, and its management is still not specific. Currently, the main pathophysiological hypothesis is an alteration of the afferences related to a dysfunction of the sensorimotor loop. An hypothesis is that this dysfunction could concern the level of tactile perception and that the damage to the distal light touch receptors could play a role in the pathophysiology. The protocol is based on the performance of tests that explore different aspects of light touch: passive, active, dynamic and static sensitivity.


Eligibility criteria: Inclusion Criteria:

* No history of upper limb involvement
* Confirmed diagnosis of segmental exclusion \> 3 months after injury (2 items assigned to 400 points)
* Able to understand simple orders

Exclusion Criteria:

* Central neurological involvement after the initial or pre-existing injury
* Truncal nerve damage
* Presence of psychiatric pathology
* Communication and/or comprehension disorders
* Presence of other pathology that may lead to sensory disorders (complicated diabetes, ductal syndrome, ...)

Primary outcomes:
measure: Difference in passive sensitivity discrimination orientation threshold between each hand in static condition.
timeFrame: once during the one-day evaluation session
measure: Difference in passive sensitivity discrimination threshold between each hand in static condition.
timeFrame: once during the one-day evaluation session
measure: Difference in passive sensitivity discrimination of pressure threshold between each hand in static condition.
timeFrame: once during the one-day evaluation session
measure: Difference in passive sensitivity discrimination threshold between each hand in dynamic condition.
timeFrame: once during the one-day evaluation session
Secondary outcomes:
measure: Difference in active sensitivity discrimination threshold between each hand in dynamic condition.
timeFrame: During the evaluation session
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
Study officials:
References: