Clinical trial NCT06239012: Reliability and Validity Evaluation of the BePoW Device
Official title: SAPA Study (Seated Posture Analysis System) : Reliability and Validity Evaluation of the BePoW Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Position Sense Disorders
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: exploratory, monocentric, reliability-validity clinical investigation
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this clinical investigation is to develop a reliable and valid device to instantly measure the subject's sitting posture in a wheelchair, without using the MCPAA scale.

Detailed description: Each subject will be invited to a single experimental session lasting approximately one hour, during which all assessments will be performed.

During the visit, the patient will complete an autonomy questionnaire and assess wheelchair fatigue. A spirometry test will be performed.

The measurements will then be recorded by the BePoW software and the occupational therapist.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age,
* Having freely consented to participate in the study (or their legal representative in the case of guardianship, in agreement with the patient),
* In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and given his/her free and informed consent for the person for whom he/she is responsible to participate in the study (in agreement with the patient).
* Temporarily or permanently wheelchair-bound,
* Affiliated with a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Has comprehension problems that prevent him/her from giving free and informed consent and from completing the investigation (following instructions, answering questionnaires),
* Suffering from a pathology (Huntington's disease, Sydenham's Chorea) preventing stable sitting posture during participation in the investigation,
* Have undergone an amputation that prevents the BePoW device from taking measurements,
* having undergone a tracheotomy preventing spirometry.
* Pregnant, parturient or breast-feeding women,
* Person deprived of liberty by a judicial decision (except guardianship or curatorship) or or administrative decision, a person under psychiatric care or admitted to a or social establishment for purposes other than research,
* Minors,
* Person in an emergency situation unable to give prior consent.

Primary outcomes:
measure: Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements
timeFrame: Immediately after inclusion
measure: Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,
timeFrame: Immediately after inclusion
Secondary outcomes:
measure: Assess the validity of BePoW measurements in relation to fatigability.
timeFrame: Immediately after inclusion
measure: Assess the validity of BePoW measurements in relation to autonomy.
timeFrame: Immediately after inclusion
measure: Assessing the validity of BePoW measurements in relation to respiratory capacity
timeFrame: Immediately after inclusion
measure: Determine the standard error measurement (SEM) on angular measurements taken by BePoW
timeFrame: Immediately after inclusion
measure: Determining the minimum detectable change (MDC) on angular measurements taken by BePoW
timeFrame: Immediately after inclusion
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint Hélier
state: Bretagne
Study officials:
References: