Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Device: SmartDrive assisting device; Device: Standard manuel wheelchair

• Registration Number: NCT02506712
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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)

Study Timeline

• Study Start: 2015-07-15
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Primary Completion: 2015-10-01
• Status Verified: 2017-01
• Study Completion: 2017-10-01
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
spinal cord injury	SmartDrive assisting device	use a wheelchair with and without a assisting device to power manuel wheelchair
spinal cord injury	Standard manuel wheelchair	use a wheelchair with and without a assisting device to power manuel wheelchair
volunteer	Standard manuel wheelchair	push a wheelchair with and without a assisting device to power manuel wheelchair
volunteer	SmartDrive assisting device	push a wheelchair with and without a assisting device to power manuel wheelchair

Primary Outcome Measures

Name	Time	Method
measure of oxygen consumption per unit time (VO2) during propulsion	30 minutes

Trial Locations

Locations (1)

hopital R Poincare; 🇫🇷 Garches, France