NCT05650398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

December 5, 2022

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Difference in passive sensitivity discrimination orientation threshold between each hand in static condition.

    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.

    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.

    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.

    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 Outcomes (1)

  • Difference in active sensitivity discrimination threshold between each hand in dynamic condition.

    During the evaluation session

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • No history of upper limb involvement
  • Able to understand simple orders

You may not qualify if:

  • 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, ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 14, 2022

Study Start

September 26, 2022

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations