- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05650398
Changes in Tactile Perception in People With Segmental Exclusion Syndrome
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nancy, France, 54000
- Institut Régional de Médecine Physique et de Réadaptation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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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)
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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)
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once during the one-day evaluation session
|
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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)
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once during the one-day evaluation session
|
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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)
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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.
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During the evaluation session
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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