Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency (FRM)
Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
* 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
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Hauts-de-Seine
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Garches, Hauts-de-Seine, Frankrijk, 92380
- Djamel Bensmail
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Using of instrumented wheel and ergometer roller
The same patient will receive two types of tests: instrumented wheel and ergometer roller.
|
Using of instrumented wheel
Using of ergometer roller
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mechanical power calculated by instrumented wheel and ergometer roller.
Tijdsspanne: 20 min
|
Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.
|
20 min
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Efficient fraction of total power calculated using instrumented wheel
Tijdsspanne: 6 min
|
Tangential power / total power
|
6 min
|
|
Efficient fraction of total power calculated using ergometer roller
Tijdsspanne: 15 min
|
Tangential power / total power
|
15 min
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Physiological parameters using instrumented wheel
Tijdsspanne: 6 min
|
Heart rate, VO2 and Borg score.
|
6 min
|
|
Physiological parameters using ergometer roller
Tijdsspanne: 15 min
|
Heart rate, VO2 and Borg score.
|
15 min
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Djamel Bensmail, MD, Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P101006
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