Spinal Cord Injuries Clinical Trial
Official title:
Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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