Spinal Cord InjuriesPAPAWNCT02244931
Comparison of Three Different Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury
A study testing Servomatic™ assisting device, E.Motion© assisting device and Standard manual Wheelchair in people with Spinal Cord Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Servomatic™ assisting device, E.Motion© assisting device and Standard manual Wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Aug 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 70 years
- Spinal cord injury C5-C8, paraplegic D1-D11, and D11 paraplegic below only for phases 1 and 2 phase 1 and 2
- Spinal cord injury D1 and above only for phase 3
- Having given free and informed consent
- Negative pregnancy test for women of childbearing age
Who cannot join
- No affiliation to a social security scheme
- Refusal to participate in the clinical trial
- Patient under guardianship
- Major cognitive disorders
- bedsores
- Functional abnormality of the shoulder
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- History of cardiovascular disease
- ECG to suspect coronary insufficiency
- Pregnant patients without effective treatment or contraceptive
- Acute complication or systemic organ
Trial locations and contacts
1 site in 1 country.
France1 site
Physical Medicine and Rehabilitation, Raymond Poincaré Hospital
Garches, 92380
About this study
Official title: Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.
The purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.
Read the detailed description
The objective of the study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.
The study consists of three distinct and independent phases:
- Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy expenditure and kinetic characteristics in comparable situations with regard to speed and workload imposed to the wheelchair-patient couple.
- Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor and indoor paths with standardised obstacles. Trajectories are to be recorded in order to allow analysis by independent experts.
- Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the patient's ability to transfer from wheelchair to car seat and from car seat to wheelchair, as well as ease of wheelchair packing in car, in the context of a standard city transport involving a car and the wheelchair.
The three phases are to be performed using the standard manual wheelchair and the three assisting devices in a randomized order.
Three different groups of patients are included in the three phases of the study.
- Conditions
- Spinal Cord Injuries
- Being tested
- Servomatic™ assisting device, E.Motion© assisting device, Standard manual Wheelchair
- Keywords
- Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device
- 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.
Servomatic™ assisting deviceDevice
Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .
E.Motion© assisting deviceDevice
E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .
Standard manual WheelchairDevice
Standard manual Wheelchair
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Performance evaluation on ergometer | Experimental | The 3 devices are experimented in random order to compare them on performance using an ergometer wheelchair:
* Servomatic™ assisting device
* E.Motion© assisting device
* Standard manual Wheelchair Receives: Device: Servomatic™ assisting device; Device: E.Motion© assisting device; Device: Standard manual Wheelchair |
| Phase 2: Comparison of maneuverability | Experimental | The 3 devices are experimented in random order to compare them on maneuverability:
* Servomatic™ assisting device
* E.Motion© assisting device
* Standard manual Wheelchair Receives: Device: Servomatic™ assisting device; Device: E.Motion© assisting device; Device: Standard manual Wheelchair |
| Phase 3: Comparison of the autonomy | Experimental | The 3 devices are experimented in random order to compare them on the autonomy they afford to patients:
* Servomatic™ assisting device
* E.Motion© assisting device
* Standard manual Wheelchair Receives: Device: Servomatic™ assisting device; Device: E.Motion© assisting device; Device: Standard manual Wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: physiological parameters : Oxygen consumption.
Measured: 3 hours
Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale
Measured: 3 hours
Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine NP PELLEGRINI, MD, Principal investigator, Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244931
- Sponsor's protocol ID
- 2011-A00151-40
- Acronym
- PAPAW
- Status last verified
- Sep 2013
- First submitted
- 15 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Guillon B, Van-Hecke G, Iddir J, Pellegrini N, Beghoul N, Vaugier I, Figere M, Pradon D, Lofaso F. Evaluation of 3 pushrim-activated power-assisted wheelchairs in patients with spinal cord injury. Arch Phys Med Rehabil. 2015 May;96(5):894-904. doi: 10.1016/j.apmr.2015.01.009. Epub 2015 Jan 22.
PubMed 25620717
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.
- ClinicalTrials.gov ID
- NCT02244931
- Acronym / sponsor ID
- PAPAW / 2011-A00151-40
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Sep 2014 (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 purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.
Detailed description
The objective of the study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.
The study consists of three distinct and independent phases:
- Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy expenditure and kinetic characteristics in comparable situations with regard to speed and workload imposed to the wheelchair-patient couple.
- Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor and indoor paths with standardised obstacles. Trajectories are to be recorded in order to allow analysis by independent experts.
- Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the patient's ability to transfer from wheelchair to car seat and from car seat to wheelchair, as well as ease of wheelchair packing in car, in the context of a standard city transport involving a car and the wheelchair.
The three phases are to be performed using the standard manual wheelchair and the three assisting devices in a randomized order.
Three different groups of patients are included in the three phases of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Performance evaluation on ergometer | Experimental | Device: Servomatic™ assisting device, Device: E.Motion© assisting device, Device: Standard manual WheelchairThe 3 devices are experimented in random order to compare them on performance using an ergometer wheelchair: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair |
| Phase 2: Comparison of maneuverability | Experimental | Device: Servomatic™ assisting device, Device: E.Motion© assisting device, Device: Standard manual WheelchairThe 3 devices are experimented in random order to compare them on maneuverability: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair |
| Phase 3: Comparison of the autonomy | Experimental | Device: Servomatic™ assisting device, Device: E.Motion© assisting device, Device: Standard manual WheelchairThe 3 devices are experimented in random order to compare them on the autonomy they afford to patients: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 70 years
- Spinal cord injury C5-C8, paraplegic D1-D11, and D11 paraplegic below only for phases 1 and 2 phase 1 and 2
- Spinal cord injury D1 and above only for phase 3
- Having given free and informed consent
- Negative pregnancy test for women of childbearing age
Key exclusion criteria (10 listed)
- No affiliation to a social security scheme
- Refusal to participate in the clinical trial
- Patient under guardianship
- Major cognitive disorders
- 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 |
|---|---|---|
| Servomatic™ assisting deviceServomatic™ is an hand controlled motorized device assisting to propel the wheelchair . | Device | Phase 1: Performance evaluation on ergometer, Phase 2: Comparison of maneuverability, Phase 3: Comparison of the autonomy |
| E.Motion© assisting deviceE.Motion© is an hand controlled motorized device assisting to propel the wheelchair . | Device | Phase 1: Performance evaluation on ergometer, Phase 2: Comparison of maneuverability, Phase 3: Comparison of the autonomy |
| Standard manual WheelchairStandard manual Wheelchair | Device | Phase 1: Performance evaluation on ergometer, Phase 2: Comparison of maneuverability, Phase 3: Comparison of the autonomy |
Primary outcome
Phase 1: physiological parameters : Oxygen consumption.
Time frame: 3 hours
Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale
Time frame: 3 hours
Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.
Time frame: 3 hours
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 19 Sep 2014.
- Derived from this study: PubMed 25620717Guillon B, Van-Hecke G, Iddir J, Pellegrini N, Beghoul N, Vaugier I, Figere M, Pradon D, Lofaso F. Evaluation of 3 pushrim-activated power-assisted wheelchairs in patients with spinal cord injury. Arch Phys Med Rehabil. 2015 May;96(5):894-904. doi: 10.1016/j.apmr.2015.01.009. Epub 2015 Jan 22.
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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.
Nadine NP PELLEGRINI, MD principal investigator
Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Servomatic™ assisting device, E.Motion© assisting device and Standard manual Wheelchair in people with Spinal Cord Injuries, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 10 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 19 Sep 2014. 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?
Phase 1: physiological parameters : Oxygen consumption. (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244931, which also lists 1 linked publication.
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 19 Sep 2014.