Comparison of Three Different Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury
- Conditions
- Spinal Cord Injuries
- Interventions
- Device: Servomatic™ assisting deviceDevice: E.Motion© assisting deviceDevice: Standard manual Wheelchair
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- 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
- Arm && Interventions
Group Intervention Description Phase 2: Comparison of maneuverability E.Motion© assisting device The 3 devices are experimented in random order to compare them on maneuverability: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair Phase 3: Comparison of the autonomy Standard manual Wheelchair 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 Phase 1: Performance evaluation on ergometer Servomatic™ assisting device 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 Phase 2: Comparison of maneuverability Standard manual Wheelchair The 3 devices are experimented in random order to compare them on maneuverability: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair Phase 3: Comparison of the autonomy Servomatic™ assisting device 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 Phase 1: Performance evaluation on ergometer E.Motion© assisting device 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 Phase 1: Performance evaluation on ergometer Standard manual Wheelchair 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 Phase 2: Comparison of maneuverability Servomatic™ assisting device The 3 devices are experimented in random order to compare them on maneuverability: * Servomatic™ assisting device * E.Motion© assisting device * Standard manual Wheelchair Phase 3: Comparison of the autonomy E.Motion© assisting device 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Physical Medicine and Rehabilitation, Raymond Poincaré Hospital
🇫🇷Garches, France