NCT01935687

Brief Summary

The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured. The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

March 4, 2013

Last Update Submit

November 17, 2017

Conditions

Spinal Cord Injury

Keywords

Instrumented WheelManual WheelchairSpinal Cord Injury (SCI)Manual wheelchair UsersAged between 18-70 years

Outcome Measures

Primary Outcomes (1)

  • Mechanical power calculated by instrumented wheel and ergometer roller.

    Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.

    20 min

Secondary Outcomes (2)

  • Efficient fraction of total power calculated using instrumented wheel

    6 min

  • Efficient fraction of total power calculated using ergometer roller

    15 min

Other Outcomes (2)

  • Physiological parameters using instrumented wheel

    6 min

  • Physiological parameters using ergometer roller

    15 min

Study Arms (1)

Using of instrumented wheel and ergometer roller

EXPERIMENTAL

The same patient will receive two types of tests: instrumented wheel and ergometer roller.

Device: Using of instrumented wheelDevice: Using of ergometer roller

Interventions

Using of instrumented wheelDEVICE

Using of instrumented wheel

Using of instrumented wheel and ergometer roller
Using of ergometer rollerDEVICE

Using of ergometer roller

Using of instrumented wheel and ergometer roller

Eligibility Criteria

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

You may qualify if:

  • Age : 18-70 years.
  • Spinal cord injured patient.
  • User of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of WST questionnaire) .
  • Affiliation to a social security scheme or entitled.
  • Informed consent dated and signed by subject or subject's legally acceptable representative (and investigator).

You may not qualify if:

  • Cognitive troubles.
  • Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Djamel Bensmail

Garches, Hauts-de-Seine, 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

  • Djamel Bensmail, MD

    Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2013

First Posted

September 5, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2015

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

FR(1)