En studie som undersöker effekterna av ett ankelrehabiliteringsprogram på gymnasieidrottare med ankelinstabilitet
12 oktober 2018 uppdaterad av: Mary Spencer Cain, Georgia State University
En randomiserad kontrollerad studie som undersöker effekterna av ett 4-veckors ankelrehabiliteringsprogram på gymnasieidrottare med kronisk fotledsinstabilitet
En randomiserad kontrollerad studie som undersöker effekterna av ett 4-veckors ankelrehabiliteringsprogram på gymnasieidrottare med kronisk fotledsinstabilitet.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
En randomiserad kontrollerad studie som undersöker effekterna av tre olika 4-veckors ankelrehabiliteringsprogram på gymnasieidrottare med kronisk fotledsinstabilitet.
Vi kommer att använda frågeformulär för att bedöma subjektiv funktionsnivå och kliniska mått för att bedöma klinisk funktionalitet via statisk och funktionell balans.
Studietyp
Interventionell
Inskrivning (Faktisk)
43
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Georgia
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Atlanta, Georgia, Förenta staterna, 30327
- Holy Innocents' Episcopal School
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Atlanta, Georgia, Förenta staterna, 30327
- The Lovett School
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Atlanta, Georgia, Förenta staterna, 30327
- The Westminister Schools
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College Park, Georgia, Förenta staterna, 30337
- Woodward Academy
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Decatur, Georgia, Förenta staterna, 30030
- Decatur High School
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Marietta, Georgia, Förenta staterna, 30062
- The Walker School
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Marietta, Georgia, Förenta staterna, 30062
- Walton High School
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inklusionskriterier:
- aktiv i minst 1,5 timmar i veckan, en historia av minst 1 betydande vristvrickning som krävde medicinsk ingripande, upprepade symtom på smärta, svullnad, svaghet, instabilitet och upprepade episoder av att ge vika.
Exklusions kriterier:
- förekomst av någon pågående skada på nedre extremiteter (diagnostiserats av en läkare inom de senaste 3 månaderna med nuvarande symtom), tidigare operation i endera benet, diagnostiserad vristvrickning under de senaste 6 veckorna, anamnes på fotledsfrakturer och/eller dislokationer.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Kontrollgrupp
Varje patient i kontrollgruppen utförde inte några rehabiliteringsövningar.
Under interventionsperioden var patienten tvungen att checka in med en medlem av forskarteamet varje vecka för att diskutera eventuella förändringar i fotleden eller rapportera eventuella skadeförekomster.
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Experimentell: Motståndsbandsgrupp
Varje session genomförde patienterna motståndsträning med hjälp av ett motståndsband i 4 riktningar av fotledsrörelser (plantarflexion, dorsalflexion, inversion och eversion).
Patienterna skulle genomföra 3 set med 10 repetitioner under varje session.
Var tredje session skulle bandmotståndet öka.
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Resistance Band - använder ett spännband för att ge motstånd under fotledsrörelser
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Experimentell: Biomekaniskt ankelplattformssystem
Systemkortet för biomekanisk fotledsplattform är ett ovalt format som använder en halv sfär på botten av brädan för att låta patienten träna på en instabil yta.
En enbensställning på deras inblandade lem utfördes på den biomekaniska fotledsplattformens systemkort medan medurs och moturs cirklar fullbordades.
Den initiala riktningsrotationen valdes av patienten och ändrades var 10:e sekund av den 40 sekunder långa försöket.
Fem 40-sekunders försök genomfördes med 1-minuters vilointervall mellan försöken.
Progressionen bestämdes av den övervakande läkaren och baserades på patientens förmåga att göra mjuka övergångar mellan riktningsändringar och fullbordande av mjuka cirkulära rotationer i båda riktningarna.
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Biomekanisk Ankel Platform System Board Group - använder olika nivåer av halvsfärer för att öka mängden rörelse som tillåts vid fotleden.
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Experimentell: Kombinationsgrupp
Patienter som slutförde kombinationsprotokollet slutförde både motståndsbandet och systemkortsprotokollet för biomekanisk fotledsplattform under varje session.
Ordningen för slutförandet av träningen balanserades för varje pass.
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Kombinationsgrupp - inkluderar både motståndsbandet och programmet Biomekaniskt fotledsplattformssystem.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Statiska balansbedömningar
Tidsram: 4 veckor
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Statisk balans kliniska tester
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4 veckor
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Funktionella balansbedömningar
Tidsram: 4 veckor
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Funktionell balans kliniska tester
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4 veckor
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Patient självrapporterade resultat
Tidsram: 4 till 12 veckor
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Frågeformulär för subjektiva patientrapporterade resultat
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4 till 12 veckor
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Benjamin M Goerger, PhD, Georgia State University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 augusti 2017
Primärt slutförande (Faktisk)
13 augusti 2018
Avslutad studie (Faktisk)
30 augusti 2018
Studieregistreringsdatum
Först inskickad
28 januari 2018
Först inskickad som uppfyllde QC-kriterierna
26 februari 2018
Första postat (Faktisk)
27 februari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CON006264
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
Inga individuella deltagardata planeras att delas med andra forskare.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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