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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT02244931
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-09
• Status Verified: 2013-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-17
• Last Update Submitted: 2014-09-17
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale	3 hours
Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.	3 hours
Phase 1: physiological parameters : Oxygen consumption.	3 hours

Trial Locations

Locations (1)

Physical Medicine and Rehabilitation, Raymond Poincaré Hospital; 🇫🇷 Garches, France