Clinical trial NCT04285970: Analysis of the Motion Activity Manual Wheelchair Users
Official title: Analysis of the Motion Activity Manual Wheelchair Users
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Keywords: detection rate of propulsion cycles
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Manuel wheelchair users

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

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:

* 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.

Exclusion Criteria:

* 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,
* Progressive etiologies: tumor, infectious, inflammatory and associated - - pathologies: head trauma, amputation,
* Patient under guardianship or curatorship,
* Pregnant or breastfeeding woman.

Primary outcomes:
measure: Confirm the identification of propulsion cycles during a journey at constant speed (5km/h)
timeFrame: 18 months
measure: Confirm the classification of propulsion cycles by effort intensity
timeFrame: 18 months
Secondary outcomes:
measure: Study of the association between the propulsion force and the coefficient of the deceleration slope
timeFrame: 18 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré Hospital - Spinal Cord Injury Unit
Study officials:
affiliation: Assistance Public - Hôpitaux de Paris
name: URC PIFO
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Boninger 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.