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Completed

NCT Number: NCT02244931

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine and Rehabilitation, Raymond Poincaré Hospital

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Servomatic™ assisting device

Device

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

E.Motion© assisting device

Device

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

Standard manual Wheelchair

Device

Standard manual Wheelchair

Primary outcomes

  1. Phase 1: physiological parameters : Oxygen consumption.

    Time frame: 3 hours

  2. Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale

    Time frame: 3 hours

  3. Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PAPAW

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2014
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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