Patients With Musculoskeletal Disorders of the Upper Limb With Symptoms of ExclusionEPPEXNCT04778111
Segmental Exclusion of the Upper Limb and Peri-personal Space
An observational study of Patients With Musculoskeletal Disorders of the Upper Limb With Symptoms of Exclusion, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Musculoskeletal Disorders of the Upper Limb With Symptoms of Exclusion
- What is being tested?
- Measurement of the actual and perceived maximum reachable distance
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
About this study
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.
- Being tested
- Measurement of the actual and perceived maximum reachable distance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the actual and perceived maximum reachable distanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with exclusion | Not described Receives: Other: Measurement of the actual and perceived maximum reachable distance | |
| Control | Not described Receives: Other: Measurement of the actual and perceived maximum reachable distance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta-MRD
Difference (in cm or in % of error) between actual maximum reachable distance and perceived maximum reachable distance
Measured: During one evaluation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start2 May 2021
- Primary completion2 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Musculoskeletal Disorders of the Upper Limb With Symptoms of ExclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778111
- Sponsor's protocol ID
- IRR-CLP-2021-3
- Acronym
- EPPEX
- Status last verified
- Jan 2022
- First submitted
- 26 Feb 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Exclusion of the Upper Limb and Peri-personal Space
- ClinicalTrials.gov ID
- NCT04778111
- Acronym / sponsor ID
- EPPEX / IRR-CLP-2021-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with exclusion | – | Other: Measurement of the actual and perceived maximum reachable distance |
| Control | – | Other: Measurement of the actual and perceived maximum reachable distance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of the actual and perceived maximum reachable distanceA 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. | Other | Control, Patients with exclusion |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Musculoskeletal Disorders of the Upper Limb With Symptoms of Exclusion, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta-MRD (time frame: During one evaluation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.