Segmental Exclusion SyndromeNCT07349173
Peripersonal Space Representation in Upper Limb Segmental Exclusion
An observational study of Segmental Exclusion Syndrome and Complex Regional Pain Syndrome (CRPS), run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
Trial summary
This study aims to evaluate the representation of action peripersonal space (PPS) in subjects suffering from unilateral segmental exclusion syndrome of the upper limb compared to healthy control subjects. Segmental exclusion is defined by non-use or under-use of a limb segment without central nervous system damage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Segmental Exclusion Syndrome, Complex Regional Pain Syndrome (CRPS), Upper Limb Neglect (Peripheral)
- What is being tested?
- Reachability Judgment Task in VR.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2025to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Age ≥ 18 years.
- No history of upper limb impairment with sequelae.
Who cannot join
- Visual impairments.
- Central neurological pathology.
- Unstabilized psychiatric pathology.
- Communication or comprehension difficulties.
- Under legal protection or unable to consent.
- Pregnant or breastfeeding women.
Show all 10Show fewer
- Cervical pathology contraindicating VR headset use.
- Epilepsy.
- Upper limb pathology unrelated to exclusion.
- Inability to stand for 40 minutes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Régional de Médecine Physique et de Réadaptation (IRR), Centre Louis Pierquin.
Nancy, 54000
Jonathan Pierret, PhD, +33 3 83 52 67 61, jonathan.pierret@ugecam.assurance-maladie.fr
About this study
Official title: Study of the Representation of Action Peripersonal Space in Participants With Unilateral Segmental Exclusion of the Upper Limb Compared to Asymptomatic Subjects
This study aims to evaluate the representation of action peripersonal space (PPS) in subjects suffering from unilateral segmental exclusion syndrome of the upper limb compared to healthy control subjects. Segmental exclusion is defined by non-use or under-use of a limb segment without central nervous system damage. The study hypothesizes that this syndrome leads to a modification (shrinkage) of the PPS representation. Participants will perform reachability judgments in a Virtual Reality (VR) environment.
Read the 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
- Conditions
- Segmental Exclusion Syndrome, Complex Regional Pain Syndrome (CRPS), Upper Limb Neglect (Peripheral)
- Being tested
- Reachability Judgment Task in VR.
- Keywords
- Peripersonal Space, Virtual Reality, Body Schema, Reachability Judgment
- Medical subject headings
- Complex Regional Pain Syndromes, Personal Space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reachability Judgment Task in VR.Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Exclusion | Patients presenting with unilateral segmental exclusion of the upper limb or part of the hand evolving for more than 3 months. Receives: Behavioral: Reachability Judgment Task in VR. | |
| Healthy Controls | symptomatic volunteers with no history of upper limb impairment with sequelae. Receives: Behavioral: Reachability Judgment Task in VR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Judgment Error of Reachability
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.
Measured: Day 1 (During the 40-minute VR assessment)
Secondary outcomes (5)
Body Perception Disturbance Score
Assessed using the Bath CRPS Body Perception Disturbance Scale (French version). Scores range from 0 to 57, with higher scores indicating greater disturbance.
Measured: Day 1 (Before VR task)
Functional Impairment Score (400-Point Hand Assessment)
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).
Measured: Day 1
Anxiety and Depression Score (HAD)
Hospital Anxiety and Depression Scale. Scores range from 0 to 21 for each dimension (Anxiety and Depression).
Measured: Day 1
Kinesiophobia Score (Tampa Scale)
Tampa Scale for Kinesiophobia (TSK). Assesses fear of movement. Scores range to 68; >40 indicates significant kinesiophobia.
Measured: Day 1
Pain Catastrophizing Score (PCS)
Pain Catastrophizing Scale. Scores range from 0 to 52.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start4 Dec 2025
- Primary completionJul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Segmental Exclusion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349173
- Sponsor's protocol ID
- IRR-CLP-2023-3
- Other IDs
- 2025-A02189-40
- Status last verified
- Mar 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Representation of Action Peripersonal Space in Participants With Unilateral Segmental Exclusion of the Upper Limb Compared to Asymptomatic Subjects
- ClinicalTrials.gov ID
- NCT07349173
- Acronym / sponsor ID
- IRR-CLP-2023-3
- Conditions
- Segmental Exclusion Syndrome, Complex Regional Pain Syndrome (CRPS), Upper Limb Neglect (Peripheral)
- Keywords
- Peripersonal Space, Virtual Reality, Body Schema, Reachability Judgment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the representation of action peripersonal space (PPS) in subjects suffering from unilateral segmental exclusion syndrome of the upper limb compared to healthy control subjects. Segmental exclusion is defined by non-use or under-use of a limb segment without central nervous system damage. The study hypothesizes that this syndrome leads to a modification (shrinkage) of the PPS representation. Participants will perform reachability judgments in a Virtual Reality (VR) environment.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Exclusion | – | Behavioral: Reachability Judgment Task in VR.Patients presenting with unilateral segmental exclusion of the upper limb or part of the hand evolving for more than 3 months. |
| Healthy Controls | – | Behavioral: Reachability Judgment Task in VR.symptomatic volunteers with no history of upper limb impairment with sequelae. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- Visual impairments.
- Central neurological pathology.
- Unstabilized psychiatric pathology.
- Communication or comprehension difficulties.
- Under legal protection or unable to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reachability Judgment Task in VR.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). | Behavioural | Healthy Controls, Patients with Exclusion |
Primary outcome
Judgment Error of Reachability
Time frame: Day 1 (During the 40-minute VR assessment)
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.
5 secondary outcomes
Body Perception Disturbance Score
Time frame: Day 1 (Before VR task)
Functional Impairment Score (400-Point Hand Assessment)
Time frame: Day 1
Anxiety and Depression Score (HAD)
Time frame: Day 1
Kinesiophobia Score (Tampa Scale)
Time frame: Day 1
Pain Catastrophizing Score (PCS)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Segmental Exclusion Syndrome and Complex Regional Pain Syndrome (CRPS), run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie Touillet, MD (+33 3 83 52 98 80, amelie.touillet@ugecam.assurance-maladie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Judgment Error of Reachability (time frame: Day 1 (During the 40-minute VR assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.