Evaluation of Physiological and Biomechanical Efficiency of the PAPAW (SmartDrive)

September 3, 2020 updated by: Centre d'Investigation Clinique et Technologique 805

The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:

Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.

Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective study mono-centric, controlled, randomized cross over. Randomization of the equipment (without and with SmartDrive).

22 SCI manual wheelchair users. 22 caregivers (healthy subjects)

Study Type

Interventional

Enrollment (Actual)

44

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
        • hopital R Poincare

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women aged between 18 and 70 years
  • spinal cord injury
  • having given free and informed consent

Exclusion Criteria:

  • No affiliation to a social security scheme
  • Refusal to participate in the clinical trial
  • Patient under guardianship
  • Major cognitive disorder
  • Bedsores
  • 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: spinal cord injury
use a wheelchair with and without a assisting device to power manuel wheelchair
Device: SmartDrive assisting device
oxygen consumption
Device: Standard manuel wheelchair
oxygen consumption
Other: volunteer
push a wheelchair with and without a assisting device to power manuel wheelchair
Device: SmartDrive assisting device
oxygen consumption
Device: Standard manuel wheelchair
oxygen consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measure of oxygen consumption per unit time (VO2) during propulsion
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

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

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

Fondation Garches

Investigators

  • Principal Investigator: Caroline Hugeron, PH, Raymond Poincaré Hospital

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 (Actual)

July 15, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00758-41

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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