Analysis of the Motion Activity Manual Wheelchair Users

Spinal Cord Injuries Clinical Trial

— Acti-FRM  

Official title:

Analysis of the Motion Activity Manual Wheelchair Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04285970
• Other study ID #: APHP190373
• Status: Recruiting
• Start date: November 4, 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Caroline Hugeron, MD
• Phone: +33147107900
• Email: caroline.hugeron[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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

Locations

Country	Name	City	State
France	Raymond Poincaré Hospital - Spinal Cord Injury Unit	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirm the identification of propulsion cycles during a journey at constant speed (5km/h)	Measurement of the detection rate of propulsion cycles	18 months
Primary	Confirm the classification of propulsion cycles by effort intensity	Classification rate of propulsion cycles	18 months
Secondary	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