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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03567109
Other study ID # 2018-A00354-51
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 13, 2018
Est. completion date July 12, 2022

Study information

Verified date June 2024
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study assess ocular movements in a hand laterality judgment task in a population of musculoskeletal disorders. Reaction time, error rate and visual strategy are compared between musculoskeletal disorders and healthy patients, and between the different locations of the disorder.


Description:

Musculoskeletal disorders are a major public health issue. Recent studies showed that body schema alterations are involved in the chronification of those disorders. Those alterations bring the opportunity for new exploration or therapeutic solutions. Our hypothesis is that musculoskeletal disorders lead to motor imagery alterations relative to body schema disorders. Reaction time extension et error rate increase in a hand laterality judgment task would confirm that hypothesis. It is assumed that body schema alterations of patients suffering from musculoskeletal disorders could change with localisation, dependant on disorder's laterality and distality. It is a monocentric, prospective, case-control trial, with 4 subgroups of 30 patients : shoulder rotator cuff tendinopathy, carpal tunnel syndrome, chronic low back pain, healthy subjects. We compare reaction time and error rate on a hand laterality judgement task. In that task, participants are asked to identify hand right or left laterality, when those hand is presented on a computer screen, by answering with the keyboard. Hands are shown on palmar or dorsal view and with 12 different angles of rotation. An eye-tracking device register participant eye movements during the task.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date July 12, 2022
Est. primary completion date July 12, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - normal visual acuity - social security affiliation - signing consent - rotator cuff tendinopathy, chronic low back pain, carpal tunnel syndrome or healthy subject Exclusion Criteria: - recent trauma or surgery - psychiatric or neurological disorder - psychotropic consumption - previous experience with motor imagery - bad french comprehension - protected persons - other painful affection than the inclusion criteria

Study Design


Intervention

Other:
hand laterality judgment task
participants are asked to identify laterality of the hand presented on the screen

Locations

Country Name City State
France CHU Angers Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary error rate at the hand laterality judgment task number of errors divided by the total number of hands presented 1 hour
Primary reaction time time to press on the keyboard the answer "Right" or "Left" after the hand was presented 1 hour
Secondary visual strategy assessment of the image's areas most fixed with the eyes 1 hour
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