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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04778111
Other study ID # IRR-CLP-2021-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2021
Est. completion date December 31, 2021

Study information

Verified date January 2022
Source Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date December 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Institut Régional de Médecine Physique et de Réadaptation Nancy

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Delta-MRD Difference (in cm or in % of error) between actual maximum reachable distance and perceived maximum reachable distance During one evaluation session