Reliability and Validity Evaluation of the BePoW Device

Position Sense Disorders Clinical Trial

— SAPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239012
• Other study ID #: 2023-A00609-36
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Pôle Saint Hélier
• Contact: Aurélie DURUFLE
• Phone: +33299295099
• Email: aurelie.durufle[@]pole-sthelier.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Position Sense Disorders
• Somatosensory Disorders

Intervention

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

Locations

Country	Name	City	State
France	Pôle Saint Hélier	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Pôle Saint Hélier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements	12 data records for each measurement for intra ICC	Immediately after inclusion
Primary	Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,	kappa coefficient between recoded measurements : BePow / MCPAA	Immediately after inclusion
Secondary	Assess the validity of BePoW measurements in relation to fatigability.	assessment using a visual numerical scale, from 0 to 10	Immediately after inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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