Comparison of Three Different Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury (PAPAW)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Standard manual Wheelchair; Device: E.Motion© assisting device; Device: Servomatic™ assisting device

Study type: Interventional

Funder types: Other

Identifiers

NCT02244931

2011-A00151-40

Details and patient eligibility

About

The purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.

Full description

The objective of the study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.

The study consists of three distinct and independent phases:

• Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy expenditure and kinetic characteristics in comparable situations with regard to speed and workload imposed to the wheelchair-patient couple.
• Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor and indoor paths with standardised obstacles. Trajectories are to be recorded in order to allow analysis by independent experts.
• Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the patient's ability to transfer from wheelchair to car seat and from car seat to wheelchair, as well as ease of wheelchair packing in car, in the context of a standard city transport involving a car and the wheelchair.

The three phases are to be performed using the standard manual wheelchair and the three assisting devices in a randomized order.

Three different groups of patients are included in the three phases of the study.

Enrollment: 106 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged between 18 and 70 years
• Spinal cord injury C5-C8, paraplegic D1-D11, and D11 paraplegic below only for phases 1 and 2 phase 1 and 2
• Spinal cord injury D1 and above only for phase 3
• Having given free and informed consent
• Negative pregnancy test for women of childbearing age

Exclusion criteria

• No affiliation to a social security scheme
• Refusal to participate in the clinical trial
• Patient under guardianship
• Major cognitive disorders
• bedsores
• Functional abnormality of the shoulder
• History of cardiovascular disease
• ECG to suspect coronary insufficiency
• Pregnant patients without effective treatment or contraceptive
• Acute complication or systemic organ

Trial design

106 participants in 3 patient groups

Phase 1: Performance evaluation on ergometer

Experimental group

Description:

The 3 devices are experimented in random order to compare them on performance using an ergometer wheelchair: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair

Treatment:

Device: Servomatic™ assisting device

Device: Standard manual Wheelchair

Device: E.Motion© assisting device

Phase 2: Comparison of maneuverability

Experimental group

Description:

The 3 devices are experimented in random order to compare them on maneuverability: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair

Treatment:

Device: Servomatic™ assisting device

Device: Standard manual Wheelchair

Device: E.Motion© assisting device

Phase 3: Comparison of the autonomy

Experimental group

Description:

The 3 devices are experimented in random order to compare them on the autonomy they afford to patients: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair

Treatment:

Device: Servomatic™ assisting device

Device: Standard manual Wheelchair

Device: E.Motion© assisting device