- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03113630
Virtual Task in Amyotrophic Lateral Sclerosis
Efficacy of Different Interaction Devices Using Virtual Task in Amyotrophic Lateral Sclerosis
Visão geral do estudo
Status
Condições
Descrição detalhada
Participants A total of 60 individuals participated in this study, 30 individuals with ALS (18 men and 12 women, mean age 59 years, range 44-74 years) and 30 healthy individuals who formed the control group, which were (equally) matched individually for age and gender with ALS group.
Rating scales For clinical characteristics of the participants, the scales of functional assessment, fatigue and quality of life were applied. As a functional assessment tool, the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS - R) was used, validated in Brazilian individuals with ALS which allows monitoring of symptoms and limitations of daily living activities. To evaluate fatigue during the execution of tasks, were used the Fatigue Severity Scale (FSS) and for the assessment of quality of life, were used the Amyotrophic Lateral Sclerosis Assessment Questionnaire in the Portuguese Language (ALSAQ-40/BR), which is also validated for the Brazilian population with ALS.
Protocol Subjects were randomly divided into three groups, using different interfaces for the acquisition of movement. The description of the task and the RV interfaces that were used are described as follows.
Task Participants performed a task to test communication devices developed by the Information Systems Team at the University of São Paulo. The task was set up as a game in which the goal was to reach as many bubbles displayed on an 11-inch computer monitor, forming seven rows and 18 columns with a total of 126 bubbles. This required individuals to be able to use a range as is typically required in communication systems. The task was divided into two phases: (1) the first phase was characterized by identification of dexterity zone or range of reach, in which the subject had to touch ("burst") the largest possible number of bubbles (changing bubble color from blue to gray) in a set time of 30 seconds, identifying the range zone; (2) the second phase was characterized as the persecution stage, at this time the researcher defined a central bubble (usually chosen in the center of the skill area, on the bottom line), which changed the color to red. From this moment the individual pursued random bubbles that appeared in their range zone, alternating with a return to the central bubble. This phase was carried out for 30 seconds. To motivate, the task randomly provided bubbles outside the range zone and generated a greater challenge to the individual. The software generated information of the coordinates x, y (row and column) where the bubble was touched and the time the bubble was touched. During task execution, the participant received feedback of the number of bubbles touched, the remaining playing time and the total number of points obtained in attempts, thus observing the performance of the participants.
Interfaces To perform the task were used 3 different interfaces: two interfaces without physical contact, being the Kinect® for Windows from Microsoft, composed of a traditional RGB camera and an infrared depth sensor (IR) and LMC®, characterized as a small motion sensor that demonstrated robustness to measure the movements of the hand and fingers. The interface with physical contact, the touchscreen, was the computer screen itself, where individuals touched the screen in order to burst the bubbles, performing the task. It is noteworthy that the touchscreen is a sensitive interface, employed through pressure, created in order to interact with digital information, found in a majority of modern consumer electronics, mainly computers, tablets and mobile phones.
Procedures and design Individuals who participated in the study gave written informed consent and then were sent to a reserved and quiet room to perform the tasks only in the presence of the researcher. The computer monitor was positioned on a table in front of the participants. The chair was adjusted in accordance with the size and need of the individual, with a footrest available if needed. For wheelchair users, their own wheelchair was used. After the necessary adjustments to perform the task, questionnaires and functional assessment scales were applied; then the researcher provided verbal instructions and performed a demonstration of interfaces according to each task (Kinect® for Windows, LMC® or touchscreen). Subjects were instructed to use the dominant hand (i.e., the least affected side) for all interfaces used during the game.
For the acquisition phase a target was set of 300 bubbles to be touched in the definition phase of the dexterity zone. There were 126 bubbles presented during each attempt; therefore it took at least three attempts to reach the proposed goal. Soon after the step establishing the dexterity zone, the researcher defined the central bubble and began the stage of chase area. In addition to the acquisition phase, all groups performed a retention test after 5 minutes with the completion of only one attempt. After the retention test, two transfer tests with the change of interfaces were performed.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Sao Paulo, Brasil, 03828-000
- Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- individuals diagnosed with ALS defined according to the revised classification of El Escorial;
- individuals who regularly attended the Neuromuscular Disease Research Sector (SIDNM) of the Federal University of São Paulo
Exclusion Criteria:
- individuals who had other diagnosis of neuromuscular disease such as: progressive muscular atrophy (PMA), progressive bulbar paralysis (PBP), primary lateral sclerosis (PLS);
- individuals associated with other neurodegenerative diseases;
- those presenting established functional disability that would prevent the completion of the task.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Aquisição no TouchScreen
Sujeitos praticam a tarefa e a retenção TouchScreen, transferem 1 no LeapMotion e transferem 2 no Kinect
|
Os participantes realizaram aquisição e retenção no TouchScreen, transferência 1 no Kinect e transferência 2 no LeapMotion.
|
|
Experimental: Aquisição no Kinect
Os sujeitos praticam a tarefa e a retenção do Kinect, transferem 1 no TouchScreen e transferem 2 no LeapMotion.
|
Os participantes realizaram aquisição e retenção no Kinect, transferência 1 no TouchScreen e transferência 2 no LeapMotion.
|
|
Experimental: Aquisição na LeapMotion
Os sujeitos praticam a tarefa e a retenção LeapMotion, transferem 1 no TouchScreen e transferem 2 no Kinect.
|
Os participantes realizaram aquisição e retenção no LeapMotion, transferência 1 no TouchScreen e transferência 2 no Kinect.
|
|
Comparador Ativo: Aquisição no Grupo de Controle TouchScreen
Sujeitos praticam a tarefa e a retenção TouchScreen, transferem 1 no LeapMotion e transferem 2 no Kinect
|
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
|
|
Comparador Ativo: Aquisição no Kinect Control Group
Os sujeitos praticam a tarefa e a retenção do Kinect, transferem 1 no TouchScreen e transferem 2 no LeapMotion.
|
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
|
|
Comparador Ativo: Aquisição do LeapMotion Control Group
Os sujeitos praticam a tarefa e a retenção LeapMotion, transferem 1 no TouchScreen e transferem 2 no Kinect.
|
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Motor performance improvement in a virtual Timing Coincident task, comparing performance between LeapMotion, TouchScreen and Kinect.
Prazo: 3 months
|
Analysis of the motor performance using a virtual Coincident timing task in different devices to compare wether a task with or without contact promote better performance for people with Amyotrophic Lateral Sclerosis
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carlos BM Monteiro, Ph.D., University of São Paulo
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 105/15
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 Esclerose Lateral Amiotrófica
-
Mayo ClinicThe Patient Company, LLCConcluídoTransferência Lateral do PacienteEstados Unidos
-
The Dental Hospital of Zhejiang University School...ConcluídoEspessura da Parede LateralChina
-
University Ramon LlullRecrutamentoEsclerose Lateral AmiotróficaEspanha
-
Hospital for Special Surgery, New YorkConcluídoEpicondilite Lateral | Epicondilite Lateral, Cotovelo Não Especificado | Epicondilite Lateral, Cotovelo Esquerdo | Epicondilite Lateral, Cotovelo Direito | Epicondilite Lateral (Cotovelo de Tenista) Bilateral | Epicondilite Medial | Epicondilite Medial, Cotovelo Direito | Epicondilite Medial, Cotovelo...Estados Unidos
-
University of BaghdadConcluídoLevantamento do seio lateralIraque
-
Centre Mutualiste de Rééducation et de Réadaptation...RecrutamentoEpicondilite Lateral do CotoveloFrança
-
Arthrex, Inc.Ativo, não recrutandoInstabilidade Lateral do TornozeloEstados Unidos
-
RAUL FIGA BARRIOSConcluídoCartilagem Articular | Ligamento lateral, tornozeloEspanha
-
National Institute of Neurological Disorders and...RecrutamentoEsclerose Lateral Amiotrófica Tipo 4 | Distúrbios Neurológicos Herdados do Processamento de RNAEstados Unidos
-
ZIWIGMonitoring Force GroupAtivo, não recrutandoEsclerose Lateral Amiotrófica | Esclerose Lateral Amiotrófica EsporádicaFrança
Ensaios clínicos em Aquisição no TouchScreen
-
Sonova AGHearts for HearingConcluído
-
Florida International UniversityNational Institute on Aging (NIA); University of Alabama, TuscaloosaRescindidoDistúrbios Neurocognitivos | Doença de Alzheimer | CuidadorEstados Unidos
-
University of Sao PauloConcluídoDistrofia Muscular de DuchenneBrasil
-
First Affiliated Hospital of Zhejiang UniversityRecrutamento
-
Dana-Farber Cancer InstituteRecrutamentoCâncer | Ansiedade | SobrevivênciaEstados Unidos
-
Kessler FoundationNational Institute on Disability, Independent Living, and Rehabilitation ResearchRecrutamentoTraumatismo crâniano | Atenção prejudicada | Regulação EmocionalEstados Unidos
-
M.D. Anderson Cancer CenterRecrutamentoDispnéiaEstados Unidos
-
Laval UniversityMinistère de la Justice, QuébecAtivo, não recrutandoTranstorno de Estresse Pós-Traumático | Transtorno Depressivo Maior | Transtorno de InsôniaCanadá
-
On-X Life Technologies, Inc.RescindidoDoença das válvulas cardíacasEstados Unidos, Porto Rico, Espanha
-
Bispebjerg HospitalUniversity of Copenhagen; Copenhagen Academy for Medical Education and SimulationRecrutamentoAprendizagem OnlineDinamarca