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OpenTrials
Completed

NCT Number: NCT02506712

Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

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.

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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

hopital R Poincare

Garches, 92380, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

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
  • 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

Treatment and study plan

SmartDrive assisting device

Device

oxygen consumption

Standard manuel wheelchair

Device

oxygen consumption

Primary outcomes

  1. measure of oxygen consumption per unit time (VO2) during propulsion

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • Fondation Garches

Registry information

Acronym: SmartDrive

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Jul 23, 2015
Registry last updated
Sep 4, 2020

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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