Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
22. mars 2019 oppdatert av: Sport and Spine Rehab Clinical Research Foundation
The Effect of Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
A convenience sample of 20 participants, 18 years or older healthy individuals were recruited.
Participants were excluded if they report being pregnant or being treated for a musculoskeletal injury.
After explanation of the study and consent were obtained, each participant completed background information and the Cumberland Ankle Instability Tool (CAIT).
Participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment.
Following the unbraced condition participants were randomly assigned into 1 of 4 conditions: [1] Active Ankle 329 Ankle Sleeve, [2] AS1Pro, [3] Eclipse 1, or [4] Eclipse 2. Participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments.
After this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace.
The protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.
Studieoversikt
Detaljert beskrivelse
A convenience sample of 20 participants, 18 years or older healthy individuals were recruited.
Participants were excluded if they report being pregnant or being treated for a musculoskeletal injury.
After explanation of the study and consent were obtained, each participant completed background information and the Cumberland Ankle Instability Tool (CAIT).
Participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment.
Following the unbraced condition participants were randomly assigned into 1 of 4 conditions: [1] Active Ankle 329 Ankle Sleeve, [2] AS1Pro, [3] Eclipse 1, or [4] Eclipse 2. Participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments.
After this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace.
The protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
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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Maryland
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Rockville, Maryland, Forente stater, 20852
- Sport & Spine Rehab
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- healthy individuals who are able to run for 10 minutes total
Exclusion Criteria:
- pregnancy, lower body injury
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Ankle Brace
Each participant will complete a baseline analysis of 1 minute of walking and 2 minutes of running, repeated 4 more times wearing 4 different braces.
The analysis will be completed on the Walker View Treadmill, which used 3D camera technology to capture lower body kinematics.
The treadmill also has load cells built in to capture gait characteristics
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Each participant will complete the 1 minute walking and 2 minute running under 5 conditions [1] un-braced, [2] Active Ankle 329 Ankle Sleeve, [3] AS1Pro (a lace-up brace), [4] Eclipse 1 (single-upright brace), and [5] Eclipse 2 (double upright brace)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Ankle Dorsiflexion/Plantarflexion Range of Motion
Tidsramme: Ankle Dorsiflexion/Plantarflexion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Ankle Dorsiflexion/Plantarflexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
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Ankle Dorsiflexion/Plantarflexion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Change in Ankle Inversion/Eversion Range of Motion
Tidsramme: Ankle Inversion/Eversion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Ankle Inversion/Eversion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
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Ankle Inversion/Eversion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Change in Knee Flexion Range of Motion
Tidsramme: Knee Flexion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
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Knee Flexion Range of Motion will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Change in Step Length
Tidsramme: Step Length will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt
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Step Length will be measured for the last 30 seconds of the 1 minute walk, and the last 30 seconds of the 2 minute run. It will be measured during each of the 5 conditions.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Faktiske)
1. april 2018
Primær fullføring (Faktiske)
1. september 2018
Studiet fullført (Faktiske)
1. januar 2019
Datoer for studieregistrering
Først innsendt
2. juli 2018
Først innsendt som oppfylte QC-kriteriene
17. august 2018
Først lagt ut (Faktiske)
21. august 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AnkleBrace Running
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .
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