Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

Spinal Cord Injuries Clinical Trial

— SmartDrive  

Official title:

Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506712
• Other study ID #: 2015-A00758-41
• Status: Completed
• Phase: N/A
• Start date: July 15, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: January 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• SmartDrive assisting device
oxygen consumption
• Standard manuel wheelchair
oxygen consumption

Locations

Country	Name	City	State
France	hopital R Poincare	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Fondation Garches

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of oxygen consumption per unit time (VO2) during propulsion		30 minutes