NCT04778111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

February 26, 2021

Last Update Submit

January 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Delta-MRD

    Difference (in cm or in % of error) between actual maximum reachable distance and perceived maximum reachable distance

    During one evaluation session

Study Arms (2)

Patients with exclusion

Other: Measurement of the actual and perceived maximum reachable distance

Control

Other: Measurement of the actual and perceived maximum reachable distance

Interventions

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.

ControlPatients with exclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 2, 2021

Study Start

May 2, 2021

Primary Completion

December 2, 2021

Study Completion

December 31, 2021

Last Updated

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations