Reliability and Validity Evaluation of the BePoW Device

NCT06239012 | Completed

• 1 other identifier: 2023-A00609-36
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Position Sense Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

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

  Immediately after inclusion

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

  Immediately after inclusion

• Assessing the validity of BePoW measurements in relation to respiratory capacity

  Immediately after inclusion

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

  Immediately after inclusion

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

  Immediately after inclusion

Study Arms (1)

position measurement with BePoW device compared with MCPAA scale measurements

EXPERIMENTAL

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

Position measurement with BePow DEVICE

14 measurements taken with the device

position measurement with BePoW device compared with MCPAA scale measurements

Position measurement with MCPAA scale OTHER

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

position measurement with BePoW device compared with MCPAA scale measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pôle Saint Hélier: lead

Study Sites (1)

Pôle Saint Hélier

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: exploratory, monocentric, reliability-validity clinical investigation

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: February 29, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

FR (1)