People With Motor DisabilitiesPARA-DREEFTNCT06524128
Evaluation of Perceived Satisfaction With the Use of the Dreeft® Device in Real-life Situations
A study testing Dreeft wheels (EPPUR company) in people with People With Motor Disabilities, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- People With Motor Disabilities
- What is being tested?
- Dreeft wheels (EPPUR company)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Jul 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged ≥ 18 years and < to 64 years.
- Participants having signed the written consent form to participate in the study after free and informed information.
- Wheelchair user for more than one year.
- Participants affiliated to a social security scheme (beneficiary or beneficiary's beneficiary) excluding AME.
- Living at home.
- Have a motor disability, whatever its origin, and use a manual wheelchair independently as their main mobility tool, with or without propulsion assistance.
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- Who propel their manual wheelchair with both upper limbs.
- Using a personal manual wheelchair compatible with Dreeft® wheels.
- Able to mount/dismount the wheels, or a third party to assist with wheel changes.
- Referred by the person's referring physician or occupational therapist on clinical indication for the device.
Who cannot join
- Participant deprived of liberty (by judicial or administrative decision).
- Participant of legal age under legal protection or unable to express consent.
- Participation in another ongoing clinical trial.
- Pregnant or breastfeeding women or women of childbearing age without contraception.
- Lack of proficiency in spoken and written French.
- Unstable health condition.
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- Mentally or linguistically incapable of understanding the instructions for taking the research tests.
- User unable to propel himself/herself independently in a manual wheelchair, hemiplegic user.
- Body weight > 120 kg
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de rééducation et de réadaptation fonctionnelles de Kerpape
Ploemeur, 56270
Centre de ressources et d'innovation mobilité handicap (CEREMH)
Vélizy-Villacoublay, 78140
About this study
Official title: PARA-DREEFT : Evaluation of Perceived Satisfaction With the Use of the Dreeft® Device in Real-life Situations
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).
Read more
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.
- Conditions
- People With Motor Disabilities
- Being tested
- Dreeft wheels (EPPUR company)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dreeft wheels (EPPUR company)Device
The braking system (Dreeft wheels) is installed directly on the participant's wheelchair, by a trained occupational therapist. The Dreeft wheels are supplied for a period of 1 month.
| Study group | Role | What they receive |
|---|---|---|
| With Dreeft® wheels | Experimental | The participant's wheelchair will be equipped with DREEFT wheels, to be used for 1 month. Receives: Device: Dreeft wheels (EPPUR company) |
| without Dreeft® wheels | No intervention | The participant's wheelchair will be equipped with its usual braking system, monitored over a period of 1 month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (7)
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.
Measured: 2 months
F-PIADS scale
Evlaluaiton of the psychosocial impact of a technical aid (using the F-PIADS scale)
Measured: 2 months
Wheelchair skill test - Questionnaire (WST-Q)
Evaluation of the manual wheelchair driving
Measured: 2 months
QUEST measurement scale (Quebec User Evaluation of Satisfaction with assistive Technology)
Evaluation of satisfaction with a technical aid
Measured: 2 months
Vancouver scale
Evaluation of changes in skin condition of hands Medical assessment
Measured: 2 months
Number of people who would like to continue using the Dreeft® device and device abandonment rate
Questionnaires
Measured: 2 months
Safety of use
Recording of adverse events and serious adverse events
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start22 Jul 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People With Motor DisabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, bicentric, single-blind, cross-over study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524128
- Sponsor's protocol ID
- 2024-A00781-46
- Acronym
- PARA-DREEFT
- Status last verified
- Oct 2025
- First submitted
- 23 Jul 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARA-DREEFT : Evaluation of Perceived Satisfaction With the Use of the Dreeft® Device in Real-life Situations
- ClinicalTrials.gov ID
- NCT06524128
- Acronym / sponsor ID
- PARA-DREEFT / 2024-A00781-46
- Conditions
- People With Motor Disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, bicentric, single-blind, cross-over study.
| Arm | Type | Receives |
|---|---|---|
| With Dreeft® wheels | Experimental | Device: Dreeft wheels (EPPUR company)The participant's wheelchair will be equipped with DREEFT wheels, to be used for 1 month. |
| without Dreeft® wheels | No intervention | –The participant's wheelchair will be equipped with its usual braking system, monitored over a period of 1 month. |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female aged ≥ 18 years and < to 64 years.
- Participants having signed the written consent form to participate in the study after free and informed information.
- Wheelchair user for more than one year.
- Participants affiliated to a social security scheme (beneficiary or beneficiary's beneficiary) excluding AME.
- Living at home.
Key exclusion criteria (9 listed)
- Participant deprived of liberty (by judicial or administrative decision).
- Participant of legal age under legal protection or unable to express consent.
- Participation in another ongoing clinical trial.
- Pregnant or breastfeeding women or women of childbearing age without contraception.
- Lack of proficiency in spoken and written French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dreeft wheels (EPPUR company)The braking system (Dreeft wheels) is installed directly on the participant's wheelchair, by a trained occupational therapist. The Dreeft wheels are supplied for a period of 1 month. | Device | With Dreeft® wheels |
Primary outcome
Canadian Measure of Occupational Performance (CMOP) - satisfaction score
Time frame: 2 months
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.
7 secondary outcomes
Canadian Measure of Occupational Performance (CMOP) - performance score
Time frame: 2 months
F-PIADS scale
Time frame: 2 months
Wheelchair skill test - Questionnaire (WST-Q)
Time frame: 2 months
QUEST measurement scale (Quebec User Evaluation of Satisfaction with assistive Technology)
Time frame: 2 months
Vancouver scale
Time frame: 2 months
Number of people who would like to continue using the Dreeft® device and device abandonment rate
Time frame: 2 months
Safety of use
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dreeft wheels (EPPUR company) in people with People With Motor Disabilities, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Measure of Occupational Performance (CMOP) - satisfaction score (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.