Changes in Tactile Perception in People With Segmental Exclusion Syndrome

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nancy, France, 54000
        • Institut Régional de Médecine Physique et de Réadaptation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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, ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in passive sensitivity discrimination orientation threshold between each hand in static condition.
Time Frame: once during the one-day evaluation session
Difference in thresholds of sensitive discrimination between the two hands in the Grating Orientation Task (mm)
once during the one-day evaluation session
Difference in passive sensitivity discrimination threshold between each hand in static condition.
Time Frame: 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)
once during the one-day evaluation session
Difference in passive sensitivity discrimination of pressure threshold between each hand in static condition.
Time Frame: once during the one-day evaluation session
Difference in thresholds of sensitive discrimination between the two hands in the monofilament test (Newton)
once during the one-day evaluation session
Difference in passive sensitivity discrimination threshold between each hand in dynamic condition.
Time Frame: once during the one-day evaluation session
Difference in thresholds of sensitive discrimination between the two hands in Moving Two-Points Discrimination Test (mm)
once during the one-day evaluation session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in active sensitivity discrimination threshold between each hand in dynamic condition.
Time Frame: During the evaluation session
Percentage of correct answers to the bar test in both groups.
During the evaluation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Actual)

February 15, 2025

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRR-CLP-2022-9

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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