Analysis of the Motion Activity Manual Wheelchair Users

• Conditions: Spinal Cord Injuries
• Interventions: Other: detection of effort intensity; Other: cycle detection

• Registration Number: NCT04285970
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-11-04
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-24
• Last Update Submitted: 2020-02-24
• Study First Posted: 2020-02-26
• Last Update Posted: 2020-02-26
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medullary injured	detection of effort intensity	Injured Medullary users of manually driven wheelchairs for daily locomotion
Healthy volunteers	cycle detection	Healthy volunteer with at least 2 hours' experience using a manual wheelchair

Primary Outcome Measures

Name	Time	Method
Confirm the identification of propulsion cycles during a journey at constant speed (5km/h)	18 months	Measurement of the detection rate of propulsion cycles
Confirm the classification of propulsion cycles by effort intensity	18 months	Classification rate of propulsion cycles

Secondary Outcome Measures

Name	Time	Method
Study of the association between the propulsion force and the coefficient of the deceleration slope	18 months	The association will be measured with propulsion force by the torque wheel and the coefficient of the deceleration slope quantified by the inertial unit

Trial Locations

Locations (1)

Raymond Poincaré Hospital - Spinal Cord Injury Unit; 🇫🇷 Garches, France