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Completed

NCT Number: NCT06239012

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle Saint Hélier

Rennes, Brittany Region, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Position measurement with BePow

Device

14 measurements taken with the device

Position measurement with MCPAA scale

Other

MCPAA : measurement of seated postural control in adults in French 12 measurements taken with the goniometer

Primary outcomes

  1. Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements

    Time frame: Immediately after inclusion

    12 data records for each measurement for intra ICC

  2. Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,

    Time frame: Immediately after inclusion

    kappa coefficient between recoded measurements : BePow / MCPAA

Secondary outcomes

  1. Assess the validity of BePoW measurements in relation to fatigability.

    Time frame: Immediately after inclusion

    assessment using a visual numerical scale, from 0 to 10

  2. Assess the validity of BePoW measurements in relation to autonomy.

    Time frame: Immediately after inclusion

    assessment by the MIF (Measure of Functional Independence) questionnaire from 21 (total dependence) to 47 (completely independent)

  3. Assessing the validity of BePoW measurements in relation to respiratory capacity

    Time frame: 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.

  4. Determine the standard error measurement (SEM) on angular measurements taken by BePoW

    Time frame: Immediately after inclusion

    Calculation of the standard error measurement (SEM) of each measurement taken by the device.

  5. Determining the minimum detectable change (MDC) on angular measurements taken by BePoW

    Time frame: Immediately after inclusion

    Calculation of the minimum detectable change (MDC) of each measurement taken by the device.

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Registry information

Official study title

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

Acronym: SAPA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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