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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Servomatic™ assisting device
* Device: E.Motion© assisting device
* Device: Standard manual Wheelchair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1: Performance evaluation on ergometer<br>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 | Device: Servomatic™ assisting device<br>* Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .<br>Device: E.Motion© assisting device<br>* E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .<br>Device: Standard manual Wheelchair<br>* Standard manual Wheelchair<br>|
| Experimental: Phase 2: Comparison of maneuverability<br>The 3 devices are experimented in random order to compare them on maneuverability: Servomatic™ assisting device E.Motion© assisting device Standard manual Wheelchair | Device: Servomatic™ assisting device<br>* Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .<br>Device: E.Motion© assisting device<br>* E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .<br>Device: Standard manual Wheelchair<br>* Standard manual Wheelchair<br>|
| Experimental: Phase 3: Comparison of the autonomy<br>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 | Device: Servomatic™ assisting device<br>* Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .<br>Device: E.Motion© assisting device<br>* E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .<br>Device: Standard manual Wheelchair<br>* Standard manual Wheelchair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: physiological parameters : Oxygen consumption. |  | 3 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device