Upper Limb Exclusion SyndromNCT05650398
Changes in Tactile Perception in People With Segmental Exclusion Syndrome
An observational study of Upper Limb Exclusion Syndrom, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
Trial summary
Segmental exclusion syndrome is characterised by the non-use or under-use of a limb segment, most oftenly reported in the distal part, following an injury, without affecting the central nervous system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Exclusion Syndrom
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2022to 15 Feb 2025
- 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 study population consisted of adults with a segmental exclusion of a finger more than 3 months after the initial injury. In order to study sensitivity disorders related to the exclusion, we decided to include only people who had no pathology that could have an impact on sensitivity and who had no truncal nerve damage at the time of the initial injury.
Who may be able to join
- No history of upper limb involvement
- Confirmed diagnosis of segmental exclusion > 3 months after injury (2 items assigned to 400 points)
- Able to understand simple orders
Who cannot join
- Central neurological involvement after the initial or pre-existing injury
- Truncal nerve damage
- Presence of psychiatric pathology
- Communication and/or comprehension disorders
- Presence of other pathology that may lead to sensory disorders (complicated diabetes, ductal syndrome, ...)
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
About this study
Segmental exclusion syndrome is characterised by the non-use or under-use of a limb segment, most oftenly reported in the distal part, following an injury, without affecting the central nervous system. This syndrome has an important negative impact on the daily life of affected subjects; however, it remains poorly studied, particularly in terms of pathophysiology, and its management is still not specific. Currently, the main pathophysiological hypothesis is an alteration of the afferences related to a dysfunction of the sensorimotor loop. An hypothesis is that this dysfunction could concern the level of tactile perception and that the damage to the distal light touch receptors could play a role in the pathophysiology. The protocol is based on the performance of tests that explore different aspects of light touch: passive, active, dynamic and static sensitivity.
- Conditions
- Upper Limb Exclusion Syndrom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with exclusion | Evaluation of the tactile sensitivity of the excluded finger using different tests: Static and dynamic two-points discrimination tests, the Semmes-Weinstein monofilament test, grating orientation task and the bar test inspired by the study of Louw et al. Realization of the same tests on the controllateral healthy finger. | |
| Control | Evaluation of the tactile sensitivity of the finger using different tests: Static and dynamic two-points discrimination tests, the Semmes-Weinstein monofilament test, grating orientation task and the bar test inspired by the study of Louw et al. Realization of the same tests on the controllateral finger. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in passive sensitivity discrimination orientation threshold between each hand in static condition.
Difference in thresholds of sensitive discrimination between the two hands in the Grating Orientation Task (mm)
Measured: once during the one-day evaluation session
Difference in passive sensitivity discrimination threshold between each hand in static condition.
Difference in thresholds of sensitive discrimination between the two hands in the Static Two Points discrimination test (mm)
Measured: once during the one-day evaluation session
Difference in passive sensitivity discrimination of pressure threshold between each hand in static condition.
Difference in thresholds of sensitive discrimination between the two hands in the monofilament test (Newton)
Measured: once during the one-day evaluation session
Difference in passive sensitivity discrimination threshold between each hand in dynamic condition.
Difference in thresholds of sensitive discrimination between the two hands in Moving Two-Points Discrimination Test (mm)
Measured: once during the one-day evaluation session
Secondary outcomes (1)
Difference in active sensitivity discrimination threshold between each hand in dynamic condition.
Percentage of correct answers to the bar test in both groups.
Measured: During the evaluation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start26 Sep 2022
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Exclusion SyndromStudies 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
- 34 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
- NCT05650398
- Sponsor's protocol ID
- IRR-CLP-2022-9
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Tactile Perception in People With Segmental Exclusion Syndrome
- ClinicalTrials.gov ID
- NCT05650398
- Acronym / sponsor ID
- IRR-CLP-2022-9
- Conditions
- Upper Limb Exclusion Syndrom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 14 Dec 2022 (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.
Segmental exclusion syndrome is characterised by the non-use or under-use of a limb segment, most oftenly reported in the distal part, following an injury, without affecting the central nervous system. This syndrome has an important negative impact on the daily life of affected subjects; however, it remains poorly studied, particularly in terms of pathophysiology, and its management is still not specific. Currently, the main pathophysiological hypothesis is an alteration of the afferences related to a dysfunction of the sensorimotor loop. An hypothesis is that this dysfunction could concern the level of tactile perception and that the damage to the distal light touch receptors could play a role in the pathophysiology. The protocol is based on the performance of tests that explore different aspects of light touch: passive, active, dynamic and static sensitivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with exclusion | – | –Evaluation of the tactile sensitivity of the excluded finger using different tests: Static and dynamic two-points discrimination tests, the Semmes-Weinstein monofilament test, grating orientation task and the bar test inspired by the study of Louw et al. Realization of the same tests on the controllateral healthy finger. |
| Control | – | –Evaluation of the tactile sensitivity of the finger using different tests: Static and dynamic two-points discrimination tests, the Semmes-Weinstein monofilament test, grating orientation task and the bar test inspired by the study of Louw et al. Realization of the same tests on the controllateral finger. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults with a segmental exclusion of a finger more than 3 months after the initial injury. In order to study sensitivity disorders related to the exclusion, we decided to include only people who had no pathology that could have an impact on sensitivity and who had no truncal nerve damage at the time of the initial injury.
Key inclusion criteria (3 listed)
- No history of upper limb involvement
- Confirmed diagnosis of segmental exclusion > 3 months after injury (2 items assigned to 400 points)
- Able to understand simple orders
Key exclusion criteria (5 listed)
- Central neurological involvement after the initial or pre-existing injury
- Truncal nerve damage
- Presence of psychiatric pathology
- Communication and/or comprehension disorders
- Presence of other pathology that may lead to sensory disorders (complicated diabetes, ductal syndrome, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in passive sensitivity discrimination orientation threshold between each hand in static condition.
Time frame: once during the one-day evaluation session
Difference in thresholds of sensitive discrimination between the two hands in the Grating Orientation Task (mm)
Difference in passive sensitivity discrimination threshold between each hand in static condition.
Time frame: once during the one-day evaluation session
Difference in thresholds of sensitive discrimination between the two hands in the Static Two Points discrimination test (mm)
Difference in passive sensitivity discrimination of pressure threshold between each hand in static condition.
Time frame: once during the one-day evaluation session
Difference in thresholds of sensitive discrimination between the two hands in the monofilament test (Newton)
Difference in passive sensitivity discrimination threshold between each hand in dynamic condition.
Time frame: once during the one-day evaluation session
Difference in thresholds of sensitive discrimination between the two hands in Moving Two-Points Discrimination Test (mm)
1 secondary outcome
Difference in active sensitivity discrimination threshold between each hand in dynamic condition.
Time frame: During the evaluation session
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 22 Aug 2025.
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 Upper Limb Exclusion Syndrom, 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 3 inclusion and 5 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 22 Aug 2025. 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?
Difference in passive sensitivity discrimination orientation threshold between each hand in static condition. (time frame: once during the one-day evaluation session). The study lists 4 primary outcomes in all. 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 22 Aug 2025.