Evaluating a device for measuring sitting posture in wheelchairs
SAPA Study (Seated Posture Analysis System) : Reliability and Validity Evaluation of the BePoW Device
NA · Pôle Saint Hélier · NCT06239012
This study is testing a new device that measures how people sit in their wheelchairs to see if it works better than current methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pôle Saint Hélier (other) |
| Locations | 1 site (Rennes, Bretagne) |
| Trial ID | NCT06239012 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to develop a reliable and valid device, the BePoW, to instantly measure a subject's sitting posture in a wheelchair without relying on the MCPAA scale. Participants will attend a single one-hour session where they will complete an autonomy questionnaire, assess wheelchair fatigue, and undergo a spirometry test. The data collected will be recorded using the BePoW software and by an occupational therapist to evaluate the device's effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are temporarily or permanently wheelchair-bound and can provide informed consent.
Not a fit: Patients with comprehension problems that hinder their ability to give informed consent or those with conditions that prevent stable sitting posture will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a more accurate and immediate assessment of sitting posture for wheelchair users, potentially improving their comfort and autonomy.
How similar studies have performed: While this approach is focused on a specific device evaluation, similar studies have shown promise in improving posture assessment methods for wheelchair users.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rennes, Bretagne
- Pôle Saint Hélier — Rennes, Bretagne, France (RECRUITING)
Study contacts
- Study coordinator: Aurélie DURUFLE
- Email: aurelie.durufle@pole-sthelier.com
- Phone: +33299295099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Position Sense Disorders