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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
* 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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Hauts-de-Seine
-
Garches, Hauts-de-Seine, Frankrike, 92380
- Djamel Bensmail
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mechanical power calculated by instrumented wheel and ergometer roller.
Tidsramme: 20 min
|
Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.
|
20 min
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Efficient fraction of total power calculated using instrumented wheel
Tidsramme: 6 min
|
Tangential power / total power
|
6 min
|
|
Efficient fraction of total power calculated using ergometer roller
Tidsramme: 15 min
|
Tangential power / total power
|
15 min
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physiological parameters using instrumented wheel
Tidsramme: 6 min
|
Heart rate, VO2 and Borg score.
|
6 min
|
|
Physiological parameters using ergometer roller
Tidsramme: 15 min
|
Heart rate, VO2 and Borg score.
|
15 min
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Djamel Bensmail, MD, Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P101006
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