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The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients

16 de noviembre de 2022 actualizado por: Murat Akıncı, Ankara Yildirim Beyazıt University
The effectiveness of applying robot-assisted walking training together with conventional physiotherapy is widely accepted. Virtual reality is another component and its contribution to rehabilitation is important. When we look at the literature on virtual reality applications on balance and walking, it is seen that some systems are beneficial while some systems have no effect. This raises the possibility that virtual reality applications may produce different results due to the task in the exercise, patient motivation or any other reason. There is a need to investigate whether virtual reality applications have different effects, if any, what is the source of this and what care should be taken in the development of these applications in the future. Therefore, we focused on investigating the different effects of Lokomat virtual reality applications.

Descripción general del estudio

Descripción detallada

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+.

Tipo de estudio

Intervencionista

Inscripción (Actual)

56

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Ankara, Pavo, 06000
        • Ankara City Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

  • 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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lokomat Group I (Endurance)
  • Faster application used with Lokomat gait training
  • Conventional Physiotherapy
  • Faster application (using for Endurance) : 3 days in a week for 6 weeks,very season was 40 min.
  • Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Experimental: Lokomat Group II (Attention and Motivation)
  • Smile and Gabarello applications used with Lokomat gait training
  • Conventional Physiotherapy
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
  • Smile application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min.
  • Gabarello application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min.
  • Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Experimental: Lokomat Group III (Activity Timing)
  • High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training
  • Conventional Physiotherapy
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
  • High Flyer application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 20 min.
  • Treasures application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min.
  • Curve Pursuit application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min.
  • Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.
Otro: Control
-Only Conventional Physiotherapy
-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in 6 MWT
Periodo de tiempo: 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.
6 weeks after treatment
Change in 10 MWT
Periodo de tiempo: 6 weeks after treatment
10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.
6 weeks after treatment
Change in BBS
Periodo de tiempo: 6 weeks after treatment
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
Change in Limits of Stability
Periodo de tiempo: 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.
6 weeks after treatment
Change in Spatiotemporal Gait Analysis
Periodo de tiempo: 6 weeks after treatment

Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters.

  • Spatial parameters:

    • Step Length
    • Step Width
    • Stride Length
  • Temporal Parameters

    • Step Time
    • Stride Time
    • Stance Time
    • Swing Time
    • Double Support Time We used C-Mill device to evaluate the spatiotemporal parameters.
6 weeks after treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Spatial Symmetry
Periodo de tiempo: 6 weeks after treatment
It is the ratio of the hemiplegic side step lenght to the non-hemiplegic side step lenght.
6 weeks after treatment
Change in Temporal Symmetry
Periodo de tiempo: 6 weeks after treatment
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.
6 weeks after treatment
Change in Postural Stability
Periodo de tiempo: 6 weeks after treatment
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.
6 weeks after treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de noviembre de 2021

Finalización primaria (Actual)

1 de junio de 2022

Finalización del estudio (Actual)

1 de junio de 2022

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2022

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2022

Publicado por primera vez (Actual)

15 de junio de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de noviembre de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

16 de noviembre de 2022

Última verificación

1 de noviembre de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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