Reliability and Validity Evaluation of the BePoW Device (SAPA)

Pôle Saint Hélier

Status: Completed

Conditions: Position Sense Disorders

Treatments: Device: Position measurement with BePow; Other: Position measurement with MCPAA scale

Study type: Interventional

Funder types: Other

Identifiers

NCT06239012

2023-A00609-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

position measurement with BePoW device compared with MCPAA scale measurements

Experimental group

Description:

Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements

Treatment:

Other: Position measurement with MCPAA scale

Device: Position measurement with BePow