- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05419791
The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Stroke is an important health problem worldwide. Emotional, cognitive, sensory and motor problems occur with stroke. Motor problems are especially balance and walking problems and they are related to each other. So balance and gait rehabilitation are primary goals in stroke.
Although the first study to support the efficacy of Lokomat is that Lokomat is superior to conventional physiotherapy in walking, there are also studies reporting that there is no difference between the effects of Lokomat and conventional physiotherapy and that conventional physiotherapy is superior. In the light of all these studies, the effectiveness of applying robotic systems together with conventional physiotherapy is widely accepted.
Robot Assisted Walking Training has many components such as guiding force, walking speed, body weight support. Virtual reality is one of these components and there is literature in which Lokomat virtual reality applications are effective on balance and walking. Although the virtual reality effect is emphasized for Lokomat, there is a lack of literature on the specific effect of different virtual reality applications. In our study, it was aimed to examine the changes caused by different Lokomat virtual reality applications in the spatiotemporal parameters of balance and gait.
Method: This study was conducted to examine the effects of Lokomat VR applications on balance and spatiotemporal parameters of gait in patients with chronic stroke; It is a prospective, randomized controlled, single-blind study. The study will be carried out in a single-blind manner, and the evaluator will not know which group the individual is in. 56 individuals with chronic stroke included our study. All individuals have been informed about the study and read and signed the consent form stating that they voluntarily participated in the study. For balance evaluation we used Berg Balance Scale and Huber 360 device, which measures postural stability and limits of stability. And for gait evaluation we used 10 MWT, 6 MWT and spatiotemporal gait analysis for C-Mill VR+.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Ankara, Turquie, 06000
- Ankara City Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Clinical diagnosis is stroke
- The time period have to be chronic period (+6 months)
- The patient must have the ability to walk with or without support
- The patiens should be able to understand Lokomat exercises
Exclusion Criteria:
- Any condition that may prevent walking with Lokomat
- Not volunteering to participate in the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Lokomat Group I (Endurance)
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-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
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Expérimental: Lokomat Group II (Attention and Motivation)
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-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
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Expérimental: Lokomat Group III (Activity Timing)
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-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
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Autre: Control
-Only Conventional Physiotherapy
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-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in 6 MWT
Délai: 6 weeks after treatment
|
6 Minutes Walk Test is a test using for walking distance.
We evaluated the change in walking distance with 6 MWT.
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6 weeks after treatment
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Change in 10 MWT
Délai: 6 weeks after treatment
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10 MWT is a test using for evaluate the gait speed.
Gait speed is a spatiotemporal parameter.
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6 weeks after treatment
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Change in BBS
Délai: 6 weeks after treatment
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Berg Balance Scale used for balance assesment.
The scale consists of 14 items and each item gets a score between 0-4.
As a result, the person evaluated gets a score between 0-56 on the berg balance scale.
A higher score means the person has better balance skills.
|
6 weeks after treatment
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Change in Limits of Stability
Délai: 6 weeks after treatment
|
Limits of Stability (LoS) are defined as the points at which the center of gravity (CoG) approaches the limits of the base of support (BoS) and a correction strategy is required to return the center of mass (CoM) to within the BoS.
In other words, LoS is the amount of maximum excursion an individual is able to intentionally cover in any direction without losing his/her balance or taking a step.
We used Huber 360 device to evaluate the LoS.
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6 weeks after treatment
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Change in Spatiotemporal Gait Analysis
Délai: 6 weeks after treatment
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Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters.
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6 weeks after treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Spatial Symmetry
Délai: 6 weeks after treatment
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It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.
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6 weeks after treatment
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Change in Temporal Symmetry
Délai: 6 weeks after treatment
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For temporal symmetry we used the description "Gait Symmetry".
Gait symmetry is calculated by the ratio of the hemiplegic side sway phase to the hemiplegic side stance phase ratio and the ratio of the non-hemiplegic side sway phase to the non-hemiplegic side stance phase ratio.
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6 weeks after treatment
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Change in Postural Stability
Délai: 6 weeks after treatment
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Postural stability refers to the ability to maintain your body in a position to effectively complete a task or demand, using large muscle groups at the shoulders, trunk, and hips.
We used Huber 360 device to evaluate the postural staiblity.
The assesments were combination of opened and closed eyes.
We recorded the COP vellocity and area.
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6 weeks after treatment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Lokomat VR
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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