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CompletedNCT02506712SmartDriveUpdated Sep 4, 2020

Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

An interventional study of SmartDrive assisting device and Standard manuel wheelchair in Spinal Cord Injuries, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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)

02

Conditions studied

  • Spinal Cord Injuries
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 44 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    spinal cord injury

    use a wheelchair with and without a assisting device to power manuel wheelchair

    Device: SmartDrive assisting device · Device: Standard manuel wheelchair

  • Other
    volunteer

    push a wheelchair with and without a assisting device to power manuel wheelchair

    Device: SmartDrive assisting device · Device: Standard manuel wheelchair

Interventions

  • DeviceSmartDrive assisting device

    oxygen consumption

  • DeviceStandard manuel wheelchair

    oxygen consumption

06

What researchers measure

Primary outcomes

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

    Time frame: 30 minutes

07

Study locations

1 site
  • hopital R Poincare
    Garches, 92380, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02506712
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
Responsible party
Sponsor
First posted
Jul 23, 2015
Start date
Jul 15, 2015
Primary completion
Oct 1, 2015
Completion
Oct 1, 2017
Last update
Sep 4, 2020

Study contacts

Caroline Hugeron, PH
principal investigator · Raymond Poincaré Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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