Spinal Cord InjuriesActi-FRMNCT04285970
Analysis of the Motion Activity Manual Wheelchair Users
An observational study of Spinal Cord Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Currently, there is no system in place to allow manual wheelchair users to know their quantities of movement activities and the intensity of effort to be provided during these propulsion movements. Based on recent work by Routhier et al. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- cycle detection and detection of effort intensity
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2019to Jun 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Manuel wheelchair users
Who may be able to join
- For the healthy user group volunteers:
- Men or women over 18 years of age,
- An experience of at least 2 hours using the manual wheelchair,
- Subject who has signed an informed and written consent,
- Affiliation to a social security system.
- For the spinal cord injured user group:
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- Men or women over 18 years of age,
- Injured Medullary users of manually propelled wheelchairs for daily locomotion (at least 30/100 at WST on travel items),
- Subject who has signed an informed and written consent,
- Affiliation to a social security system.
Who cannot join
- Patient refusing to participate in the study,
- Manual wheelchair users with propulsion assistance system,
- Major cognitive disorders,
- Unbalanced cardiovascular disease,
- Pressure sores and unhealed palm lesions,
- Asthma to effort,
Show all 9Show fewer
- Progressive etiologies: tumor, infectious, inflammatory and associated - - pathologies: head trauma, amputation,
- Patient under guardianship or curatorship,
- Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Raymond Poincaré Hospital - Spinal Cord Injury Unit
Garches, 92380
Caroline Hugeron, MD, +33 1 47 10 79 00, caroline.hugeron@aphp.fr
Sandra Pottier, +33 1 47 41 93 07, sandra.pottier@handicap.org
About this study
Currently, there is no system in place to allow manual wheelchair users to know their quantities of movement activities and the intensity of effort to be provided during these propulsion movements. Based on recent work by Routhier et al. in 2017, and in light of the scientific literature related to wheelchair propulsion, it would seem appropriate to validate the use of inertial units as tools to quantify and categorize the intensity of manual wheelchair propulsion.
Read the detailed description
The investigator hypothesize that an inertial unit positioned on the wheelchair wheel has the same detection rate of the propulsion cycle as a dynamometric wheel (step 1). In addition, the investigator hypothesize that the categorization of the detected propulsion cycle as a function of force intensity is similar between the angular deceleration of the wheel during propulsion calculated from the inertial unit and the external mechanical power calculated from a dynamometric wheel (step 2).
- Conditions
- Spinal Cord Injuries
- Being tested
- cycle detection, detection of effort intensity
- Keywords
- detection rate of propulsion cycles
- 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.
cycle detectionOther
6-minute test on a treadmill at pedestrian speed (5km/h) with 2 instruments (dynamometric wheel and inertial centre) on a standardised wheelchair
detection of effort intensityOther
6-minute test on an urban course with 2 instruments (dynamometric wheel and inertial units) on a wheelchair
| Study group | Role | What they receive |
|---|---|---|
| Medullary injured | Injured Medullary users of manually driven wheelchairs for daily locomotion Receives: Other: detection of effort intensity | |
| Healthy volunteers | Healthy volunteer with at least 2 hours' experience using a manual wheelchair Receives: Other: cycle detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm the identification of propulsion cycles during a journey at constant speed (5km/h)
Measurement of the detection rate of propulsion cycles
Measured: 18 months
Confirm the classification of propulsion cycles by effort intensity
Classification rate of propulsion cycles
Measured: 18 months
Secondary outcomes (1)
Study of the association between the propulsion force and the coefficient of the deceleration slope
The association will be measured with propulsion force by the torque wheel and the coefficient of the deceleration slope quantified by the inertial unit
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start4 Nov 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- URC PIFO, Study director, Assistance Public - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285970
- Sponsor's protocol ID
- APHP190373
- Acronym
- Acti-FRM
- Status last verified
- Jul 2019
- First submitted
- 17 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boninger ML, Cooper RA, Baldwin MA, Shimada SD, Koontz A. Wheelchair pushrim kinetics: body weight and median nerve function. Arch Phys Med Rehabil. 1999 Aug;80(8):910-5. doi: 10.1016/s0003-9993(99)90082-5.
PubMed 10453767Boninger ML, Souza AL, Cooper RA, Fitzgerald SG, Koontz AM, Fay BT. Propulsion patterns and pushrim biomechanics in manual wheelchair propulsion. Arch Phys Med Rehabil. 2002 May;83(5):718-23. doi: 10.1053/apmr.2002.32455.
PubMed 11994814
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Motion Activity Manual Wheelchair Users
- ClinicalTrials.gov ID
- NCT04285970
- Acronym / sponsor ID
- Acti-FRM / APHP190373
- Conditions
- Spinal Cord Injuries
- Keywords
- detection rate of propulsion cycles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 26 Feb 2020 (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.
Currently, there is no system in place to allow manual wheelchair users to know their quantities of movement activities and the intensity of effort to be provided during these propulsion movements. Based on recent work by Routhier et al. in 2017, and in light of the scientific literature related to wheelchair propulsion, it would seem appropriate to validate the use of inertial units as tools to quantify and categorize the intensity of manual wheelchair propulsion.
Detailed description
The investigator hypothesize that an inertial unit positioned on the wheelchair wheel has the same detection rate of the propulsion cycle as a dynamometric wheel (step 1). In addition, the investigator hypothesize that the categorization of the detected propulsion cycle as a function of force intensity is similar between the angular deceleration of the wheel during propulsion calculated from the inertial unit and the external mechanical power calculated from a dynamometric wheel (step 2).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medullary injured | – | Other: detection of effort intensityInjured Medullary users of manually driven wheelchairs for daily locomotion |
| Healthy volunteers | – | Other: cycle detectionHealthy volunteer with at least 2 hours' experience using a manual wheelchair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Manuel wheelchair users
Key inclusion criteria (10 listed)
- Men or women over 18 years of age,
- An experience of at least 2 hours using the manual wheelchair,
- Subject who has signed an informed and written consent,
- Affiliation to a social security system.
- Men or women over 18 years of age,
Key exclusion criteria (9 listed)
- Patient refusing to participate in the study,
- Manual wheelchair users with propulsion assistance system,
- Major cognitive disorders,
- Unbalanced cardiovascular disease,
- Pressure sores and unhealed palm lesions,
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 |
|---|---|---|
| cycle detection6-minute test on a treadmill at pedestrian speed (5km/h) with 2 instruments (dynamometric wheel and inertial centre) on a standardised wheelchair | Other | Healthy volunteers |
| detection of effort intensity6-minute test on an urban course with 2 instruments (dynamometric wheel and inertial units) on a wheelchair | Other | Medullary injured |
Primary outcome
Confirm the identification of propulsion cycles during a journey at constant speed (5km/h)
Time frame: 18 months
Measurement of the detection rate of propulsion cycles
Confirm the classification of propulsion cycles by effort intensity
Time frame: 18 months
Classification rate of propulsion cycles
1 secondary outcome
Study of the association between the propulsion force and the coefficient of the deceleration slope
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Background: PubMed 10453767Boninger ML, Cooper RA, Baldwin MA, Shimada SD, Koontz A. Wheelchair pushrim kinetics: body weight and median nerve function. Arch Phys Med Rehabil. 1999 Aug;80(8):910-5. doi: 10.1016/s0003-9993(99)90082-5.
- Background: PubMed 11994814Boninger ML, Souza AL, Cooper RA, Fitzgerald SG, Koontz AM, Fay BT. Propulsion patterns and pushrim biomechanics in manual wheelchair propulsion. Arch Phys Med Rehabil. 2002 May;83(5):718-23. doi: 10.1053/apmr.2002.32455.
- 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.
URC PIFO study director
Assistance Public - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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: status not confirmed, as of the sponsor's last update on 26 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Hugeron, MD (+33147107900, caroline.hugeron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the identification of propulsion cycles during a journey at constant speed (5km/h) (time frame: 18 months). The study lists 2 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 NCT04285970, which also lists 2 linked publications.
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 26 Feb 2020.