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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SmartDrive assisting device
Standard manuel wheelchair
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • hopital R Poincare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

spinal cord injury

volunteer

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 21, 2015
Last Updated
September 3, 2020
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
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1. Study Identification

Unique Protocol Identification Number
NCT02506712
Brief Title
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW
Acronym
SmartDrive
Official Title
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 15, 2015 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spinal cord injury
Arm Type
Experimental
Arm Description
use a wheelchair with and without a assisting device to power manuel wheelchair
Arm Title
volunteer
Arm Type
Other
Arm Description
push a wheelchair with and without a assisting device to power manuel wheelchair
Intervention Type
Device
Intervention Name(s)
SmartDrive assisting device
Intervention Description
oxygen consumption
Intervention Type
Device
Intervention Name(s)
Standard manuel wheelchair
Intervention Description
oxygen consumption
Primary Outcome Measure Information:
Title
measure of oxygen consumption per unit time (VO2) during propulsion
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Hugeron, PH
Organizational Affiliation
Raymond Poincaré Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
hopital R Poincare
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

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Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

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