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Changes in Tactile Perception in People With Segmental Exclusion Syndrome

Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est (Other)
Overall Status
Recruiting
CT.gov ID
NCT05650398
Collaborator
(none)
40
Enrollment
1
Location
18.2
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Changes in Tactile Perception in People With Segmental Exclusion Syndrome
    Actual Study Start Date :
    Sep 26, 2022
    Anticipated Primary Completion Date :
    Sep 26, 2023
    Anticipated Study Completion Date :
    Apr 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with exclusion

    Evaluation of the tactile sensitivity of the excluded finger using different tests: Static and dynamic two-points discrimination tests, the Semmes-Weinstein monofilament test, grating orientation task and the bar test inspired by the study of Louw et al. Realization of the same tests on the controllateral healthy finger.
    Control

    Evaluation of the tactile sensitivity of the finger using different tests: Static and dynamic two-points discrimination tests, the Semmes-Weinstein monofilament test, grating orientation task and the bar test inspired by the study of Louw et al. Realization of the same tests on the controllateral finger.

    Outcome Measures

    Primary Outcome Measures

    1. Difference in passive sensitivity discrimination orientation threshold between each hand in static condition. [once during the one-day evaluation session]

      Difference in thresholds of sensitive discrimination between the two hands in the Grating Orientation Task (mm)

    2. Difference in passive sensitivity discrimination threshold between each hand in static condition. [once during the one-day evaluation session]

      Difference in thresholds of sensitive discrimination between the two hands in the Static Two Points discrimination test (mm)

    3. Difference in passive sensitivity discrimination of pressure threshold between each hand in static condition. [once during the one-day evaluation session]

      Difference in thresholds of sensitive discrimination between the two hands in the monofilament test (Newton)

    4. Difference in passive sensitivity discrimination threshold between each hand in dynamic condition. [once during the one-day evaluation session]

      Difference in thresholds of sensitive discrimination between the two hands in Moving Two-Points Discrimination Test (mm)

    Secondary Outcome Measures

    1. Difference in active sensitivity discrimination threshold between each hand in dynamic condition. [During the evaluation session]

      Percentage of correct answers to the bar test in both groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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, ...)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Régional de Médecine Physique et de Réadaptation Nancy France 54000

    Sponsors and Collaborators

    • Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
    ClinicalTrials.gov Identifier:
    NCT05650398
    Other Study ID Numbers:
    • IRR-CLP-2022-9
    First Posted:
    Dec 14, 2022
    Last Update Posted:
    Dec 22, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 22, 2022