Evaluation of Perceived Satisfaction With the Use of the Dreeft® Device in Real-life Situations
NCT Number: NCT06524128
Acronym: PARA-DREEFT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: People With Motor Disabilities
Interventions: DEVICE: Dreeft wheels (EPPUR company)
Sponsor: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-22
Completion Date: 2025-07-21
Locations: Centre de rééducation et de réadaptation fonctionnelles de Kerpape, Ploemeur, 56270, France|Centre de ressources et d'innovation mobilité handicap (CEREMH), Vélizy-Villacoublay, 78140, France

Summary:
Functional, independent mobility is essential for everyone (Fasciglione, 2017). It determines everyone's ability to engage in activities of daily living and contributes to maintaining health and well-being (Fasciglione, 2017).

However, the number of people with mobility limitations is increasing. Indeed, due to the aging of the population and the growing number of people with chronic diseases, the prevalence of people experiencing mobility-related limitations is increasing rapidly (Berardi et al., 2021); in addition to this health problems (such as osteoarticular, muscular, neurological diseases) and accidents are the cause of 23.6% and 42% of mobility-related limitation situations respectively (Camirand \& Institut de la statistique du Québec, 2011).

To overcome these limitations, some people require the use of a manual wheelchair to enable mobility. Globally, wheelchair mobility (manual or motorized) refers to "the ability to move independently with a wheelchair, and to overcome obstacles encountered in carrying out activities of daily living or social roles" (Routhier et al., 2003, p. 20). This definition emphasizes that the use of a wheelchair enables independent movement.

In the past, the wheelchairs available were limited, expensive and rudimentary. Recent technological advances have given people access to a wide range of devices, adaptable to the majority of motor impairments and enabling movement in a wider variety of environments. Today's manual wheelchairs are increasingly sophisticated. However, they have no braking system other than the immobilizer that locks the wheels. Users have no choice but to use their hands as brake pads when gripping the handrail to slow down and stop.

A preliminary survey conducted by EPPUR among 164 manual wheelchair users, between March and May 2020, has shown that 75% of manual wheelchair users express difficulty braking with their wheelchair or resort to assistance from a third party (EPPUR). Worryingly, 50% of survey respondents reported having lost control of their wheelchair on a slope or ramp. Finally, in their daily lives, 85% of respondents reported having already changed their route to avoid a slope. For wheelchair users, negotiating sloping streets means constant braking.

The Dreeft® system was developed on the basis of these observations. No other system for braking manual wheelchairs is currently available. As described in the previous sections, the technology developed is based on the design of the hub which integrates the braking system, operating by back-pedaling. The manual wheelchair user benefits from improved responsiveness and manoeuvrability, with no friction on the hands. Adapted to manual wheelchairs, this innovative braking system is a potential revolution for users.

In order to confirm the benefits and functional contribution of the Dreeft® device in real life, a clinical study will be carried out.

Primary Outcome Measures: Canadian Measure of Occupational Performance (CMOP) - satisfaction score, The Canadian Measure of Occupational Performance (CMOP) will be used to assess changes in perceived satisfaction with daily living tasks identified as priorities by the user, and involving mobility with the wheelchair., 2 months
Secondary Outcome Measures: Canadian Measure of Occupational Performance (CMOP) - performance score, The Canadian Measure of Occupational Performance (CMOP) will also be used to determine changes in perceived performance during the performance of daily living tasks identified as priorities by the user and involving a mobility action with the wheelchair., 2 months|F-PIADS scale, Evlaluaiton of the psychosocial impact of a technical aid (using the F-PIADS scale), 2 months|Wheelchair skill test - Questionnaire (WST-Q), Evaluation of the manual wheelchair driving, 2 months|QUEST measurement scale (Quebec User Evaluation of Satisfaction with assistive Technology), Evaluation of satisfaction with a technical aid, 2 months|Vancouver scale, Evaluation of changes in skin condition of hands Medical assessment, 2 months|Number of people who would like to continue using the Dreeft® device and device abandonment rate, Questionnaires, 2 months|Safety of use, Recording of adverse events and serious adverse events, 2 months