- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02601456
Changes in Trans Tibial Amputee Running Asymmetry During Prolonged Effort
14. oktober 2017 oppdatert av: Sheba Medical Center
The Effect of Prolonged Effort on the Bilateral Asymmetry in Trans Tibial Amputee Running With Running Specific Prosthesis
The purpose of this study is to determine the effect of prolonged effort in long distance running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee running with running specific prosthesis.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
10
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ramat Gan, Israel
- Sheba Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
community sample
Beskrivelse
Inclusion Criteria:
- Unilateral traumatic trans tibial amputee.
- Experience in running with running specific prosthesis.
- Ability to run for at least 20 minutes.
Exclusion Criteria:
- Injury or other orthopedic or neurologic issue that compromises the gait.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The changes in step length asymmetry after prolonged effort in running on a treadmill.
Tidsramme: Several measurements during 20-30 minutes run.
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Step length will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30.
If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
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Several measurements during 20-30 minutes run.
|
The changes in contact time asymmetry after prolonged effort in running on a treadmill.
Tidsramme: Several measurements during 30 minutes run.
|
Contact time will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30.
If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
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Several measurements during 30 minutes run.
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The changes in flight time asymmetry after prolonged effort in running on a treadmill.
Tidsramme: Several measurements during 30 minutes run.
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Flight time will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30.
If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
|
Several measurements during 30 minutes run.
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The changes in hip angles asymmetry after prolonged effort in running on a treadmill.
Tidsramme: Several measurements during 30 minutes run.
|
Hip angles will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30.
If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
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Several measurements during 30 minutes run.
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The changes in knee angles asymmetry after prolonged effort in running on a treadmill.
Tidsramme: Several measurements during 30 minutes run.
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Knee angles will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30.
If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
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Several measurements during 30 minutes run.
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The changes in vertical ground reaction force asymmetry after prolonged effort in running. on a treadmill
Tidsramme: Several measurements during 30 minutes run.
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Vertical ground reaction force will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30.
If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
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Several measurements during 30 minutes run.
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The changes in ground reaction impulse asymmetry after prolonged effort in running on a treadmill.
Tidsramme: Several measurements during 30 minutes run.
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Vertical ground reaction impulse will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30.
If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
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Several measurements during 30 minutes run.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Itzhak Ziev-Ner, Dr., Sheba Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2016
Primær fullføring (Forventet)
1. mai 2018
Studiet fullført (Forventet)
1. mai 2018
Datoer for studieregistrering
Først innsendt
5. november 2015
Først innsendt som oppfylte QC-kriteriene
9. november 2015
Først lagt ut (Anslag)
10. november 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. oktober 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHEBA-14-1834-ISN-CTIL
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .