NCT02506712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 4, 2020

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

July 21, 2015

Last Update Submit

September 3, 2020

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

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

    30 minutes

Study Arms (2)

spinal cord injury

EXPERIMENTAL

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

Device: SmartDrive assisting deviceDevice: Standard manuel wheelchair

volunteer

OTHER

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

Device: SmartDrive assisting deviceDevice: Standard manuel wheelchair

Interventions

SmartDrive assisting deviceDEVICE

oxygen consumption

spinal cord injuryvolunteer
Standard manuel wheelchairDEVICE

oxygen consumption

spinal cord injuryvolunteer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hopital R Poincare

Garches, 92380, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Caroline Hugeron, PH

    Raymond Poincaré Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 23, 2015

Study Start

July 15, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2017

Last Updated

September 4, 2020

Record last verified: 2017-01

Locations

FR(1)