Analysis of the Motion Activity Manual Wheelchair Users (Acti-FRM)

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: detection of effort intensity; Other: cycle detection

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 Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Raymond Poincaré Hospital - Spinal Cord Injury Unit
    • Contact: Caroline Hugeron, MD; Phone Number: +33 1 47 10 79 00; Email: caroline.hugeron@aphp.fr
    • Contact: Sandra Pottier; Phone Number: +33 1 47 41 93 07; Email: sandra.pottier@handicap.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Manuel wheelchair users

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medullary injured; Injured Medullary users of manually driven wheelchairs for daily locomotion	Other: detection of effort intensity; 6-minute test on an urban course with 2 instruments (dynamometric wheel and inertial units) on a wheelchair
Healthy volunteers; Healthy volunteer with at least 2 hours' experience using a manual wheelchair	Other: cycle detection; 6-minute test on a treadmill at pedestrian speed (5km/h) with 2 instruments (dynamometric wheel and inertial centre) on a standardised wheelchair

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: URC PIFO, Assistance Public - Hôpitaux de Paris

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: detection rate of propulsion cycles
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: APHP190373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No