- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04778111
Segmental Exclusion of the Upper Limb and Peri-personal Space (EPPEX)
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Nancy, France, 54000
- Institut Régional de Médecine Physique et de Réadaptation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
|
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
|
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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-2021-3
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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