Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524128
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Evaluation of Perceived Satisfaction With the Use of the Dreeft Device in Real-life Situations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PARA-DREEFT Evaluation of Perceived Satisfaction With the Use of the Dreeft Device in Real-life Situations
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARA-DREEFT
Brief Summary:
Functional independent mobility is essential for everyone Fasciglione 2017 It determines everyones 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 236 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 Todays 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
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 236 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 Todays 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None