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临床试验/NCT07349173
NCT07349173招募中不适用

Study of the Representation of Action Peripersonal Space in Participants With Unilateral Segmental Exclusion of the Upper Limb Compared to Asymptomatic Subjects

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Judgment Error of Reachability

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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.

排除标准

  • 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.

研究组 & 干预措施

Patients with Exclusion

Patients presenting with unilateral segmental exclusion of the upper limb or part of the hand evolving for more than 3 months.

干预措施: Reachability Judgment Task in VR. (Behavioral)

Healthy Controls

symptomatic volunteers with no history of upper limb impairment with sequelae.

干预措施: Reachability Judgment Task in VR. (Behavioral)

结局指标

主要结局

Judgment Error of Reachability

时间窗: 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.

次要结局

  • Body Perception Disturbance Score(Day 1 (Before VR task))
  • Anxiety and Depression Score (HAD)(Day 1)
  • Kinesiophobia Score (Tampa Scale)(Day 1)
  • Pain Catastrophizing Score (PCS)(Day 1)
  • Functional Impairment Score (400-Point Hand Assessment)(Day 1)

研究者

发起方
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
申办方类型
Other
责任方
Sponsor

研究点 (1)

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