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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02244931
Acronym
PAPAW
Enrollment
106
Registered
2014-09-19
Start date
2011-09-30
Completion date
2014-08-31
Last updated
2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device

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.

Interventions

DEVICEServomatic™ assisting device

Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .

DEVICEE.Motion© assisting device

E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .

DEVICEStandard manual Wheelchair

Standard manual Wheelchair

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Phase 1: physiological parameters : Oxygen consumption.3 hours
Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale3 hours
Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.3 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026