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Immersive Virtual Reality During Robot-assisted Walking.

23 de abril de 2019 atualizado por: Emma De Keersmaecker, Vrije Universiteit Brussel

The Use of Immersive Virtual Reality During Robot-assisted Walking in Healthy Adults - Effect of Changing the Optic Flow Speed in Two Different Virtual Environments on Active Participation During Robot-assisted Walking.

The aim of this study is to investigate the effect of manipulating the optic flow (OF) speed in 2 different virtual environments (VE) on active participation in healthy participants during virtual reality (VR) - enhanced robot-assisted gait(RAG).

The second aim is to investigate the effect of two different VEs on active participation during RAG.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

STUDY DESIGN: an experimental, 2-group, single-center trial will be conducted in which healthy participants will perform one VR-enhanced RAG session in which 3 different OF speeds will be presented in a random order: 1) walking with slow OF speed, 2) walking with matched OF speed, and 3) walking with fast OF speed. The VE will be different for both groups. The experimental group will have a stimulus rich VE that represents a park where subjects will walk through. This VE will be more interactive by allowing other avatars or animals to walk through the VE. The control group will have a stimulus poor VE that represents an endless hallway. Since the subjects will walk alone in the hallway for the entire time, this VE will be less interactive.

PATIENT RECRUITMENT: we aim to recruit 28 healthy participants, divided equally into two groups. In case subjects drop out, additional participants will be tested till 14 participants in each group completed all conditions.

PROCEDURE: Participants will be tested during one VR-enhanced RAG session at the rehabilitation center TrainM (Antwerp). Prior to the start of the experiment, surface electrodes will be placed bilateral on the Mm. rectus femoris and Mm. biceps femoris to measure muscle activity. Electrode placement will follow as closely as possible the guidelines of SENIAM. The skin underlying the electrode will be shaved and cleaned to improve electrode-skin contact and reduce impedance. At the start of the session, participants will be habituated to walking in the Lokomat without the VR. During this habituation trial, the appropriate settings to walk comfortable in the exoskeleton will be determined. To make sure all participants will walk comfortable in the Lokomat, subjects will be provided with a body weight support (BWS) of 30%. Guidance Force (GF) will be set on 80% for all participants. With lower levels of GF, the biofeedback values will show smaller changes and can become negligible. Lastly, the walking speed (WS) will be set at 2.8 km/h for all participants. Preparing and installing the participant and determining the appropriate Lokomat settings will take no longer than 20 minutes. When the Lokomat settings are defined, the Lokomat will be stopped for a moment so that the VR can be added. Participants will put on the head-mounted display (HMD) and will start walking again for one minute while watching the VE scene expanding at a speed matching their walking speed to get used to the VR. After the habituation trial, participants will walk in the Lokomat with the three different OF speeds that will be presented in a random order for 7 minutes each:

  1. slower OF: 0.5 times the individual's WS,
  2. matched OF: same as the individual's WS,
  3. faster OF: 2 times the individual's WS.

In order to normalize the registered EMG signals, the maximum voluntary isometric contraction (MVIC) test will be used. Each subject carries out the MVIC test 3 times for each muscle. Subjects must reach their maximum strength as quickly as possible and must keep it for 6 seconds. Subjects will perform the MVIC test in the following testing positions: prone with the knees in 30° of flexion (Mm. biceps femoris); seated with the knees in 60°of flexion, and the hips in 90° of flexion (Mm. rectus femoris). The average of the three tests will be taken for each muscle.

RANDOMIZATION: Subjects who agree to participate in this study will be equally randomized in a 1:1 ratio into 2 groups. For randomization, sealed envelopes will be prepared in advance and marked on the inside with a VE + or VE -. During the intervention, the speed of the OF (slow, matched or fast) will also be randomized. To participants, it will only be said that they will have to walk in the Lokomat with the VR for 21 minutes. They will not know that and when the speed of the OF will change.

MATERIALS: The VR will be provided with the use of a novel HMD VR system 'Oculus Rift' (Oculus Rift, LLC, US). The Oculus Rift promises the user more immersion and visual clarity of the virtual rendered world, by use of a custom display and optics technology designed specifically for VR.

Surface EMG electrodes will be used to measure the muscle activity of the Mm. rectus femoris and Mm. biceps femoris. Surface EMG data will be captured with the ME6000 EMG-system (Mega Electronics Ltd) using Conmed Cleartrace electrodes (Ag/AgCl) with an active diameter of 10mm.

The Lokomat has a biofeedback system that measures and displays participants' activity in real-time. With the use of force sensors, this biofeedback system measures the torques acting onto the corresponding Lokomat joint. This is calculated from the signals of the force sensors in the drives. Positive values correspond to external forces (from the subject) acting into flexion direction, while negative values correspond to external forces (from the subject) acting into extension. Besides force sensors, the Lokomat also comprises position sensors. These sensors will be used to measure the range of motion (ROM) of the hip- and knee joints. A value of 0 corresponds to a neutral position, positive values corresponds to flexion and negative values to extension.

STATISTICAL ANALYSIS: Statistics will be performed using SPSS (IBM, Chicago, IL). The significance level will be set on 5%. Descriptive statistics will be calculated for baseline participant characteristics. Means and standard deviations will be calculated for continues variables and frequencies and percentages for categorical variables. Active participation will be determined with the use of muscle activity (EMG), interaction torques and range of motion and will be measured continuously during the session. Data analysis of the average of every minute will be conducted. To investigate the effect of time, the different OF speeds, and the different VEs, repeated-measures ANOVA (within-between subject design) will be analyzed.

Tipo de estudo

Intervencional

Inscrição (Real)

28

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Antwerp, Bélgica, 2018
        • Rehabilitation center TrainM

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

55 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Healthy persons ≥ 55 years of age,
  2. Normal or corrected-to-normal vision with glasses or contact lenses,
  3. No locomotion impairments,
  4. A maximal body weight of 135 kg,
  5. A maximal body height of 200 cm

Exclusion Criteria:

  1. Skin lesions that cannot be protected appropriately,
  2. Significant lower extremity injuries during the last two years that might affect their gait,
  3. Any type of vestibular/visual deficiency

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Stimulus rich VE
Participants will be tested during 1 RAG session in the Lokomat. Participants in the experimental group will walk in a stimulus rich VE such as walking in a park.
Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).
Comparador Ativo: Stimulus poor VE
Participants will be tested during 1 RAG session in the Lokomat. Participants in the control group will walk in a stimulus poor VE, such as walking through an endless hallway.
Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Muscle activity (EMG)
Prazo: Every minute of the 21-minute session.
Muscle activity will be measured continuously during the 21 minutes of testing. Average muscle activity (%MVIC) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques left hip
Prazo: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques left knee
Prazo: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques right hip
Prazo: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Interaction torques right knee
Prazo: Every minute of the 21-minute session.
Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion left hip
Prazo: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion left knee
Prazo: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion right hip
Prazo: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.
Range of motion right knee
Prazo: Every minute of the 21-minute session.
Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.
Every minute of the 21-minute session.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Emma De Keersmaecker, Ph.D student, Vrije Universiteit Brussel

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

12 de setembro de 2018

Conclusão Primária (Real)

13 de abril de 2019

Conclusão do estudo (Real)

13 de abril de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

19 de fevereiro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de março de 2018

Primeira postagem (Real)

8 de março de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de abril de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de abril de 2019

Última verificação

1 de abril de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Lokomat study with VR - I

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Stimulus rich VE

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