Spinal Cord InjuriesSmartDriveNCT02506712
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW
A study testing SmartDrive assisting device and Standard manuel wheelchair in people with Spinal Cord Injuries, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed: Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SmartDrive assisting device and Standard manuel wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2015to 1 Oct 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women aged between 18 and 70 years
- spinal cord injury
- having given free and informed consent
Who cannot join
- No affiliation to a social security scheme
- Refusal to participate in the clinical trial
- Patient under guardianship
- Major cognitive disorder
- Bedsores
- Acute complication or systemic organ
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:
Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.
Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.
Read the detailed description
Prospective study mono-centric, controlled, randomized cross over. Randomization of the equipment (without and with SmartDrive).
22 SCI manual wheelchair users. 22 caregivers (healthy subjects)
- Conditions
- Spinal Cord Injuries
- Being tested
- SmartDrive assisting device, Standard manuel wheelchair
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartDrive assisting deviceDevice
oxygen consumption
Standard manuel wheelchairDevice
oxygen consumption
| Study group | Role | What they receive |
|---|---|---|
| spinal cord injury | Experimental | use a wheelchair with and without a assisting device to power manuel wheelchair Receives: Device: SmartDrive assisting device; Device: Standard manuel wheelchair |
| volunteer | Other | push a wheelchair with and without a assisting device to power manuel wheelchair Receives: Device: SmartDrive assisting device; Device: Standard manuel wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of oxygen consumption per unit time (VO2) during propulsion
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study start15 Jul 2015
- Primary completion1 Oct 2015
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches
- Responsible party
- Sponsor
- Investigators
- Caroline Hugeron, PH, Principal investigator, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506712
- Sponsor's protocol ID
- 2015-A00758-41
- Acronym
- SmartDrive
- Status last verified
- Jan 2017
- First submitted
- 21 Jul 2015
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physiological and Biomechanical Efficiency of the PAPAW
- ClinicalTrials.gov ID
- NCT02506712
- Acronym / sponsor ID
- SmartDrive / 2015-A00758-41
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 23 Jul 2015 (estimated)
- 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.
The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:
Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.
Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.
Detailed description
Prospective study mono-centric, controlled, randomized cross over. Randomization of the equipment (without and with SmartDrive).
22 SCI manual wheelchair users. 22 caregivers (healthy subjects)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal cord injury | Experimental | Device: SmartDrive assisting device, Device: Standard manuel wheelchairuse a wheelchair with and without a assisting device to power manuel wheelchair |
| volunteer | Other | Device: SmartDrive assisting device, Device: Standard manuel wheelchairpush a wheelchair with and without a assisting device to power manuel wheelchair |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women aged between 18 and 70 years
- spinal cord injury
- having given free and informed consent
Key exclusion criteria (6 listed)
- No affiliation to a social security scheme
- Refusal to participate in the clinical trial
- Patient under guardianship
- Major cognitive disorder
- Bedsores
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 |
|---|---|---|
| SmartDrive assisting deviceoxygen consumption | Device | spinal cord injury, volunteer |
| Standard manuel wheelchairoxygen consumption | Device | spinal cord injury, volunteer |
Primary outcome
measure of oxygen consumption per unit time (VO2) during propulsion
Time frame: 30 minutes
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 4 Sep 2020.
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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.
Caroline Hugeron, PH principal investigator
Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartDrive assisting device and Standard manuel wheelchair in people with Spinal Cord Injuries, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 3 inclusion and 6 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
measure of oxygen consumption per unit time (VO2) during propulsion (time frame: 30 minutes). 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 4 Sep 2020.