Changes in Tactile Perception in People With Segmental Exclusion Syndrome
1 other identifier
observational
34
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
Typical duration for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2025
CompletedAugust 22, 2025
August 1, 2025
2.4 years
December 5, 2022
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
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
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