Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency (FRM)
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Using of instrumented wheel
Using of ergometer roller
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Instrumented Wheel, Manual Wheelchair, Spinal Cord Injury (SCI), Manual wheelchair Users, Aged between 18-70 years
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Cognitive troubles.
- Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.
Sites / Locations
- Djamel Bensmail
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Using of instrumented wheel and ergometer roller
Arm Description
The same patient will receive two types of tests: instrumented wheel and ergometer roller.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Efficient fraction of total power calculated using instrumented wheel
Tangential power / total power
Efficient fraction of total power calculated using ergometer roller
Tangential power / total power
Full Information
NCT ID
NCT01935687
First Posted
March 4, 2013
Last Updated
November 17, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01935687
Brief Title
Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency
Acronym
FRM
Official Title
Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
* The manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age …etc.
Although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do.
The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission.
The primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation.
The primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test.
This study is interventional, mono-centric, controlled and crossover. The population concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.
Number of subjects projected for the entire study: 62 patients The total duration of participation of each patient: 7 days ±2days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Instrumented Wheel, Manual Wheelchair, Spinal Cord Injury (SCI), Manual wheelchair Users, Aged between 18-70 years
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Using of instrumented wheel and ergometer roller
Arm Type
Experimental
Arm Description
The same patient will receive two types of tests: instrumented wheel and ergometer roller.
Intervention Type
Device
Intervention Name(s)
Using of instrumented wheel
Intervention Description
Using of instrumented wheel
Intervention Type
Device
Intervention Name(s)
Using of ergometer roller
Intervention Description
Using of ergometer roller
Primary Outcome Measure Information:
Title
Mechanical power calculated by instrumented wheel and ergometer roller.
Description
Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Efficient fraction of total power calculated using instrumented wheel
Description
Tangential power / total power
Time Frame
6 min
Title
Efficient fraction of total power calculated using ergometer roller
Description
Tangential power / total power
Time Frame
15 min
Other Pre-specified Outcome Measures:
Title
Physiological parameters using instrumented wheel
Description
Heart rate, VO2 and Borg score.
Time Frame
6 min
Title
Physiological parameters using ergometer roller
Description
Heart rate, VO2 and Borg score.
Time Frame
15 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
Cognitive troubles.
Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djamel Bensmail, MD
Organizational Affiliation
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Djamel Bensmail
City
Garches
State/Province
Hauts-de-Seine
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency
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