Evaluation of Physiological and Biomechanical Efficiency... | NCT02506712

Studies
Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

NCT02506712

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Sep 4, 2020Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Spinal Cord Injuries

Interventions

SmartDrive assisting device
Standard manuel wheelchair

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2015Actual

Primary Completion Date

Oct 1, 2015Actual

Completion Date

Oct 1, 2017Actual

First Submitted Date

Jul 21, 2015

First Submission Date that Met QC Criteria

Jul 22, 2015

First Posted Date

Jul 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2020

Last Update Posted Date

Sep 4, 2020Actual

Name	Class
Fondation Garches	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
spinal cord injury	Experimental	use a wheelchair with and without a assisting device to power manuel wheelchair	Device: SmartDrive assisting device Device: Standard manuel wheelchair
volunteer	Other	push a wheelchair with and without a assisting device to power manuel wheelchair	Device: SmartDrive assisting device Device: Standard manuel wheelchair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SmartDrive assisting device	Device	oxygen consumption	spinal cord injury volunteer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measure of oxygen consumption per unit time (VO2) during propulsion		30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caroline Hugeron, PH	Raymond Poincaré Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
hopital R Poincare		Garches		92380	France

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided