Analysis of the Motion Activity Manual Wheelchair Users

NCT04285970 | Unknown DMC

• 1 other identifier: APHP190373
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

detection rate of propulsion cycles

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Study of the association between the propulsion force and the coefficient of the deceleration slope

  18 months

Study Arms (2)

Medullary injured

Injured Medullary users of manually driven wheelchairs for daily locomotion

Other: detection of effort intensity

Healthy volunteers

Healthy volunteer with at least 2 hours' experience using a manual wheelchair

Other: cycle detection

Interventions

cycle detection OTHER

6-minute test on a treadmill at pedestrian speed (5km/h) with 2 instruments (dynamometric wheel and inertial centre) on a standardised wheelchair

Healthy volunteers

detection of effort intensity OTHER

6-minute test on an urban course with 2 instruments (dynamometric wheel and inertial units) on a wheelchair

Medullary injured

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Manuel wheelchair users

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Raymond Poincaré Hospital - Spinal Cord Injury Unit

Garches, 92380, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 10453767 BACKGROUND

• 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.

  PMID: 11994814 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• URC PIFO

  Assistance Public - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Caroline Hugeron, MD

CONTACT

+33147107900; caroline.hugeron@aphp.fr

Sandra Pottier

CONTACT

+33147419307; sandra.pottier@handicap.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 26, 2020
• Study Start: November 4, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 26, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)