- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349173
Peripersonal Space Representation in Upper Limb Segmental Exclusion
Study of the Representation of Action Peripersonal Space in Participants With Unilateral Segmental Exclusion of the Upper Limb Compared to Asymptomatic Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Segmental exclusion syndrome often occurs after limb trauma and manifests as a neglect-like behavior of peripheral origin, sometimes associated with Complex Regional Pain Syndrome (CRPS). The study explores whether the lack of limb use affects the representation of peripersonal space (PPS)-the space immediately surrounding the body where interactions with objects occur.
The study is monocentric, observational, with a matched control group. Participants will undergo:
Clinical assessment (questionnaires on pain, anxiety, body perception, and kinesiophobia).
A Virtual Reality (VR) test (approx. 40 minutes). In VR, participants will judge whether a cylinder presented at different distances and angles is reachable without moving (Perceived Reachable Distance - DMA-p). This will be compared to their Real Reachable Distance (DMA-r).
The goal is to measure the error of judgment to assess PPS representation and check for correlations with body schema disturbances or functional impairment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amélie Touillet, MD
- Phone Number: +33 3 83 52 98 80
- Email: amelie.touillet@ugecam.assurance-maladie.fr
Study Contact Backup
- Name: Jonahtan Pierret, PhD
- Phone Number: +33 3 83 52 67 61
- Email: jonathan.pierret@ugecam.assurance-maladie.fr
Study Locations
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Nancy, France, 54000
- Recruiting
- Institut Régional de Médecine Physique et de Réadaptation (IRR), Centre Louis Pierquin.
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Contact:
- Jonathan Pierret, PhD
- Phone Number: +33 3 83 52 67 61
- Email: jonathan.pierret@ugecam.assurance-maladie.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
he study population consists of two groups recruited at the Institut Régional de Réadaptation (Centre Louis Pierquin, UGECAM Nord-Est) in Nancy, France.
Patients with Exclusion: Participants are selected from patients receiving routine care (full hospitalization or day hospital) at the center. They are identified based on a functional assessment ("Bilan 400 points") showing specific impairments related to unilateral upper limb exclusion evolving for more than 3 months.
Healthy Controls: Asymptomatic volunteers are recruited through the social or family network of the investigators and current participants, as well as via posters displayed in the UGECAM centers.
Description
Inclusion Criteria (patients):
- Age ≥ 18 years.
- Presenting unilateral exclusion symptom of the upper limb or part of the hand evolving for > 3 months.
- No contraindication to force work in daily activities.
- For patients with finger exclusion: at least 2 perturbed items related to exclusion on tests 3 and 4 of the "Bilan 400 points".
- Affiliated to a social security scheme.
- Able to understand simple orders.
Inclusion Criteria (Controls):
- Age ≥ 18 years.
- No history of upper limb impairment with sequelae.
Exclusion Criteria (All):
- Visual impairments.
- Central neurological pathology.
- Unstabilized psychiatric pathology.
- Communication or comprehension difficulties.
- Under legal protection or unable to consent.
- Pregnant or breastfeeding women.
- Cervical pathology contraindicating VR headset use.
- Epilepsy.
- Upper limb pathology unrelated to exclusion.
- Inability to stand for 40 minutes.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with Exclusion
Patients presenting with unilateral segmental exclusion of the upper limb or part of the hand evolving for more than 3 months.
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Participants wear an Oculus Quest 2 VR headset.
They first perform a motor task to measure Real Reachable Distance (DMA-r).
Then, they perform a perceptual task where they must judge, without moving, if a virtual object is reachable (DMA-p).
The test evaluates different spatial planes (front, 45° right, 45° left) and heights (shoulder, navel).
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Healthy Controls
symptomatic volunteers with no history of upper limb impairment with sequelae.
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Participants wear an Oculus Quest 2 VR headset.
They first perform a motor task to measure Real Reachable Distance (DMA-r).
Then, they perform a perceptual task where they must judge, without moving, if a virtual object is reachable (DMA-p).
The test evaluates different spatial planes (front, 45° right, 45° left) and heights (shoulder, navel).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Judgment Error of Reachability
Time Frame: Day 1 (During the 40-minute VR assessment)
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The Judgment Error of Reachability is a single composite metric calculated as: ((DMA-p - DMA-r) / DMA-r) × 100, expressed as a percentage (%). Both DMA-p (Perceived Maximum Reachable Distance) and DMA-r (Real Maximum Reachable Distance) are measured in centimeters, and their ratio yields a single dimensionless percentage score. |
Day 1 (During the 40-minute VR assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Body Perception Disturbance Score
Time Frame: Day 1 (Before VR task)
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Assessed using the Bath CRPS Body Perception Disturbance Scale (French version).
Scores range from 0 to 57, with higher scores indicating greater disturbance.
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Day 1 (Before VR task)
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Anxiety and Depression Score (HAD)
Time Frame: Day 1
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Hospital Anxiety and Depression Scale.
Scores range from 0 to 21 for each dimension (Anxiety and Depression).
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Day 1
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Kinesiophobia Score (Tampa Scale)
Time Frame: Day 1
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Tampa Scale for Kinesiophobia (TSK).
Assesses fear of movement.
Scores range to 68; >40 indicates significant kinesiophobia.
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Day 1
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Pain Catastrophizing Score (PCS)
Time Frame: Day 1
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Pain Catastrophizing Scale.
Scores range from 0 to 52.
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Day 1
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Functional Impairment Score (400-Point Hand Assessment)
Time Frame: Day 1
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Evaluated using the 400-Point Hand Assessment, which measures functional hand use.
The score ranges from 0 to 400, where higher scores indicate better functional performance (better outcome).
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Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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-2023-3
- 2025-A02189-40 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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