Changes in Tactile Perception in People With Segmental Exclusion Syndrome

NCT ID: NCT05650398

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-26

Study Completion Date

2025-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Limb Exclusion Syndrom

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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, ...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Régional de Médecine Physique et de Réadaptation

Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRR-CLP-2022-9

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Agency in Dystonia
NCT03351218 COMPLETED NA