- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03641066
Progressing Ankle Brace Restriction on Walking and Running Gait Characteristics in Healthy Individuals
22 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Rockville, Maryland, États-Unis, 20852
- Sport & Spine Rehab
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- healthy individuals who are able to run for 10 minutes total
Exclusion Criteria:
- pregnancy, lower body injury
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Ankle Dorsiflexion/Plantarflexion Range of Motion
Délai: 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
|
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.
|
|
Change in Ankle Inversion/Eversion Range of Motion
Délai: 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.
|
Ankle Inversion/Eversion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
|
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
Délai: 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.
|
Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera
|
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.
|
|
Change in Step Length
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2018
Achèvement primaire (Réel)
1 septembre 2018
Achèvement de l'étude (Réel)
1 janvier 2019
Dates d'inscription aux études
Première soumission
2 juillet 2018
Première soumission répondant aux critères de contrôle qualité
17 août 2018
Première publication (Réel)
21 août 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AnkleBrace Running
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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