Reliability and Validity Evaluation of the BePoW Device (SAPA)

SAPA Study (Seated Posture Analysis System) : Reliability and Validity Evaluation of the BePoW Device

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.

Study Overview

• Status: Completed
• Conditions: Position Sense Disorders
• Intervention / Treatment: Device: Position measurement with BePow; Other: Position measurement with 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Pôle Saint Hélier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: position measurement with BePoW device compared with MCPAA scale measurements; Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements	Device: Position measurement with BePow; 14 measurements taken with the device; Other: Position measurement with MCPAA scale; MCPAA : measurement of seated postural control in adults in French 12 measurements taken with the goniometer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the validity of BePoW measurements in relation to fatigability.	assessment using a visual numerical scale, from 0 to 10	Immediately after inclusion
Assess the validity of BePoW measurements in relation to autonomy.	assessment by the MIF (Measure of Functional Independence) questionnaire from 21 (total dependence) to 47 (completely independent)	Immediately after inclusion
Assessing the validity of BePoW measurements in relation to respiratory capacity	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.	Immediately after inclusion
Determine the standard error measurement (SEM) on angular measurements taken by BePoW	Calculation of the standard error measurement (SEM) of each measurement taken by the device.	Immediately after inclusion
Determining the minimum detectable change (MDC) on angular measurements taken by BePoW	Calculation of the minimum detectable change (MDC) of each measurement taken by the device.	Immediately after inclusion

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Actual): December 3, 2024
• Study Completion (Actual): December 3, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Somatosensory Disorders
• Other Study ID Numbers: 2023-A00609-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No