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

September 17, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Physical Medicine and Rehabilitation, Raymond Poincaré Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1: Performance evaluation on ergometer

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
Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .
Device: E.Motion© assisting device
E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .
Device: Standard manual Wheelchair
Standard manual Wheelchair
Experimental: Phase 2: Comparison of maneuverability

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
Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .
Device: E.Motion© assisting device
E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .
Device: Standard manual Wheelchair
Standard manual Wheelchair
Experimental: Phase 3: Comparison of the autonomy

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
Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .
Device: E.Motion© assisting device
E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .
Device: Standard manual Wheelchair
Standard manual Wheelchair

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Nadine NP PELLEGRINI, MD, Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00151-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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