CClinicalTrials.gg
CompletedNCT06239012SAPAUpdated Aug 1, 2025

Reliability and Validity Evaluation of the BePoW Device

An interventional study of Position measurement with BePow and Position measurement with MCPAA scale in Position Sense Disorders, sponsored by Pôle Saint Hélier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by Pôle Saint Hélier · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Position Sense Disorders
03

In context

Somatosensory Disorders

61 studies on the registry are indexed under Somatosensory Disorders; 8 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 42 interventional studies indexed under Somatosensory Disorders.

Browse Somatosensory Disorders studies →

Lead sponsor

Pôle Saint Hélier is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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 · Other: Position measurement with MCPAA scale

Interventions

  • DevicePosition measurement with BePow

    14 measurements taken with the device

  • OtherPosition measurement with MCPAA scale

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

06

What researchers measure

Primary outcomes

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

    12 data records for each measurement for intra ICC

    Time frame: Immediately after inclusion

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

    kappa coefficient between recoded measurements : BePow / MCPAA

    Time frame: Immediately after inclusion

Secondary outcomes

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

    assessment using a visual numerical scale, from 0 to 10

    Time frame: Immediately after inclusion

  2. 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)

    Time frame: Immediately after inclusion

  3. 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.

    Time frame: Immediately after inclusion

  4. 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.

    Time frame: Immediately after inclusion

  5. 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.

    Time frame: Immediately after inclusion

07

Study locations

1 site
  • Pôle Saint Hélier
    Rennes, Brittany Region 35000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06239012
Lead sponsor
Pôle Saint Hélier
Responsible party
Sponsor
First posted
Feb 2, 2024
Start date
Feb 29, 2024
Primary completion
Dec 3, 2024
Completion
Dec 3, 2024
Last update
Aug 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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