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Spatial Cognitive Training for Chronic Vestibular Disorders

8 de setembro de 2020 atualizado por: Brooke Klatt, University of Pittsburgh
In this study the investigators propose to apply cognitive training, which has been largely used in the realm of age-related cognitive decline, dementia, and Alzheimer's disease, in a novel clinical context to individuals with vestibular impairment. In prior work the investigators observed that individuals with vestibular loss have evidence of spatial cognitive impairment. The investigators plan to evaluate the preliminary efficacy and feasibility of a cognitive training program in a sample of participants with chronic vestibular impairment who display deficits in spatial ability. The cognitive training program will focus on visuospatial skills and will be used as an adjunct to traditional vestibular physical therapy (VPT).

Visão geral do estudo

Status

Retirado

Condições

Intervenção / Tratamento

Descrição detalhada

Patients with chronic vestibular dysfunction with report symptoms of spatial cognitive impairment will be offered cognitive training. The intervention will consist of a well-validated cognitive training protocol that specifically targets spatial navigation skills. The protocol was developed by Willis et al. for the Adult Development and Enrichment Trial (ADEPT) trial, which trains map reading and route-learning skills through mental rotation training tasks over the course of 5 weeks. Patients will be assessed by study staff pre-intervention, immediately post-intervention and at 3 months post-intervention using spatial cognitive outcomes, quality of life measures, and gait and balance outcomes.

Tipo de estudo

Intervencional

Estágio

  • Não aplicável

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Diagnosis of chronic vestibular disorder (>6months & diagnosis from laboratory testing by neuro-otologist)

Exclusion Criteria:

  • Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.

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: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Spatial Cognitive Training
map reading and route-learning skills
Comportamental: Spatial Cognitive Training
map reading and route-learning skills

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in Dizziness Handicap Inventory
Prazo: Baseline vs immediately post-training
Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory
Prazo: Immediately post-training to 3 months post-training
Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
Immediately post-training to 3 months post-training
Change from baseline in Dynamic Gait Index
Prazo: Baseline vs immediately post-training
Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Dynamic Gait Index
Prazo: Immediately post-training to 3 months post-training
Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.
Immediately post-training to 3 months post-training
Change from baseline in Four Square Step Test
Prazo: Baseline vs immediately post-training
Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Four Square Step Test
Prazo: Immediately post-training to 3 months post-training
Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)
Immediately post-training to 3 months post-training

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in Money Road Map Test
Prazo: Baseline vs immediately post-training
Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Money Road Map Test
Prazo: Immediately post-training to 3 months post-training
Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
Immediately post-training to 3 months post-training
Change from baseline in Benton Visual Retention Test
Prazo: Baseline vs immediately post-training
visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Benton Visual Retention Test
Prazo: Immediately post-training to 3 months post-training
visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
Immediately post-training to 3 months post-training
Change from baseline in modified Clinical Test of Sensory Organization and Balance
Prazo: Baseline vs immediately post-training
Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance
Prazo: Immediately post-training to 3 months post-training
Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
Immediately post-training to 3 months post-training
Change from baseline in Activities-specific Balance Confidence Scale
Prazo: Baseline vs immediately post-training
Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale
Prazo: Immediately post-training to 3 months post-training
Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
Immediately post-training to 3 months post-training
Change from baseline in Santa Barbara Sense of Direction Scale
Prazo: Baseline vs immediately post-training
15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.
Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale
Prazo: Immediately post-training to 3 months post-training
15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.
Immediately post-training to 3 months post-training

Colaboradores e Investigadores

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

Patrocinador

University of Pittsburgh

Colaboradores

Johns Hopkins University

Investigadores

  • Investigador principal: Brooke Klatt, PhD, PT, University of Pittsburgh

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 (Antecipado)

1 de junho de 2020

Conclusão Primária (Antecipado)

30 de junho de 2020

Conclusão do estudo (Antecipado)

31 de agosto de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

11 de maio de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de maio de 2019

Primeira postagem (Real)

15 de maio de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2020

Última verificação

1 de setembro de 2020

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY19030436

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

dissemination of study findings in manuscript publication in scientific journal

Prazo de Compartilhamento de IPD

1 year

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

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 .

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