Reliability and Validity Evaluation of the BePoW Device

Not Applicable

Recruiting

• Conditions: Position Sense Disorders
• Interventions: Device: Position measurement with BePow; Other: Position measurement with MCPAA scale

• Registration Number: NCT06239012
• Lead Sponsor: Pôle Saint Hélier

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.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Status Verified: 2024-02
• Study First Posted: 2024-02-02
• Study Start: 2024-02-29
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
position measurement with BePoW device compared with MCPAA scale measurements	Position measurement with BePow	Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements
position measurement with BePoW device compared with MCPAA scale measurements	Position measurement with MCPAA scale	Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements

Primary Outcome Measures

Name	Time	Method
Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,	Immediately after inclusion	kappa coefficient between recoded measurements : BePow / MCPAA
Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements	Immediately after inclusion	12 data records for each measurement for intra ICC

Secondary Outcome Measures

Name	Time	Method
Assess the validity of BePoW measurements in relation to fatigability.	Immediately after inclusion	assessment using a visual numerical scale, from 0 to 10
Assess the validity of BePoW measurements in relation to autonomy.	Immediately after inclusion	assessment by the MIF (Measure of Functional Independence) questionnaire from 21 (total dependence) to 47 (completely independent)
Determining the minimum detectable change (MDC) on angular measurements taken by BePoW	Immediately after inclusion	Calculation of the minimum detectable change (MDC) of each measurement taken by the device.
Assessing the validity of BePoW measurements in relation to respiratory capacity	Immediately after inclusion	assessed by the ratio of forced expiratory volume in one second (FEV1) to FEV1 at 6 seconds (FEV 6).; Spirometry will be performed 3 times, with the highest value retained.
Determine the standard error measurement (SEM) on angular measurements taken by BePoW	Immediately after inclusion	Calculation of the standard error measurement (SEM) of each measurement taken by the device.

Trial Locations

Locations (1)

Pôle Saint Hélier; 🇫🇷 Rennes, Bretagne, France