Segmental Exclusion of the Upper Limb and Peri-personal Space (EPPEX)

January 3, 2022 updated by: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

This study is based on previous studies on the search of the limit of the peri-personal space. In a previous study, Gouzien et al. (2017) evaluated the peri-personal space of action of patients with upper limb amputations and sought a link between this space and the level of integration of their myoelectric prosthesis. We have decided to implement part of this protocol to evaluate the peri-personal space for another population with upper limb patholog: segmental exclusion of the upper limb.

Exclusion is a phenomenon that is very little studied but known to orthopedic surgeons and physical medicine and rehabilitation physicians. It is characterized by the non-use or underuse of a limb segment in the absence of central nervous system involvement. This phenomenon is compared to peripheral neglect. Most of the time, the patient is unaware of his disorder "he forgets his finger without realizing it", but this phenomenon can be reversible under verbal exhortation from a third party.

The aim of this study is to observe if there is a change in peri-personal space in patients with unilateral segmental exclusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Institut Régional de Médecine Physique et de Réadaptation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients included in this study are patients with upper extremity musculoskeletal disorders of traumatic origin. To these disorders is added a segmental exclusion syndrome, which is defined as the under-use or non-use of part of the upper limb.

Description

Inclusion Criteria:

  • Adult (age greater than or equal to 18 years old).
  • Person with a symptom of unilateral exclusion.
  • Person with no contraindication to hard work in activities of daily living due to the lesions.
  • Person who has given informed consent.

Exclusion Criteria:

  • Person under 18 years of age.
  • Person with visual impairment
  • A person with a central neurological pathology.
  • A person with cognitive impairment related to a brain injury, psychiatric illness or intellectual disability.
  • A person who has difficulty understanding instructions.
  • A person of full age who is subject to a legal protection measure or who is unable to give consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Other: Measurement of the actual and perceived maximum reachable distance
A device (a table) will present luminous targets (green circles) to the subjects. Subjects will be asked to determine whether or not they are able to reach this target with their upper limb.
Patients with exclusion
Other: Measurement of the actual and perceived maximum reachable distance
A device (a table) will present luminous targets (green circles) to the subjects. Subjects will be asked to determine whether or not they are able to reach this target with their upper limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta-MRD
Time Frame: During one evaluation session
Difference (in cm or in % of error) between actual maximum reachable distance and perceived maximum reachable distance
During one evaluation session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2021

Primary Completion (ACTUAL)

December 2, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (ACTUAL)

March 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRR-CLP-2021-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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