- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07568821
Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns
Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality
A randomized comparative study will be conducted to evaluate the rehabilitation process using a VR-based application versus conventional therapy in 40 patients (sample size determined using a sample size calculator). After meeting the eligibility criteria, participants will be randomly assigned to two groups: the experimental group (20 patients with gait pattern asymmetry), performing a gait training program using a VR rehabilitation application, and the control group (20 patients with gait pattern asymmetry), performing only a conventional gait training program.
Participants in both groups will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours. Patient assessment will be conducted twice: an initial evaluation before the start of the intervention (Assessment I) and a follow-up evaluation after completion of the 2-week program (Assessment II), at the same time of day, under the same conditions, and using the same measurement tools.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Individuals with a diagnosed and clinically confirmed asymmetry of gait pattern will be eligible for inclusion in the study.
Exclusion criteria: Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions affecting the safety and effectiveness of rehabilitation, Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea), Lower limb injuries or surgeries within the last 6 months, Severe mental disorders preventing understanding of instructions.
Training for both groups will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading. Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance. The effects of gait training will be evaluated using the following measures: gait speed, walking endurance, independent mobility and risk of falls, balance, gait symmetry, spinal mobility, and functional performance.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Agnieszka Guzik
- Número de telefone: +48 17 851 8965
- E-mail: aguzik@ur.edu.pl
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Diagnosed and clinically confirmed gait pattern asymmetry in the course of neurological diseases
- Informed consent to participate in the study and willingness to comply with rehabilitation recommendations
Exclusion Criteria:
- Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions that may affect the safety and effectiveness of rehabilitation
- Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea)
- Lower limb injuries or surgeries within the last 6 months
- Severe mental disorders preventing understanding of instructions
- Lack of informed consent to participate in the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Controlo: Reabilitação Padrão
|
The control group will participate only in a conventional gait training program.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
|
|
Experimental: VR Therapy and Standard Rehabilitation
|
The experimental group will participate in a gait training program using a VR rehabilitation application.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Gait speed - 10-meter walk test
Prazo: Baseline (Day 1)
|
Baseline (Day 1)
|
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Gait speed - 10-meter walk test
Prazo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Walking Endurance - 6-Minute Walk Test
Prazo: Baseline (Day 1)
|
Baseline (Day 1)
|
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Walking Endurance - 6-Minute Walk Test
Prazo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Prazo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Prazo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
|
Lower Limb Loading Symmetry - Two-Scale Test
Prazo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
Lower Limb Loading Symmetry - Two-Scale Test
Prazo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gait and Balance - Dynamic Gait Index
Prazo: Baseline (Day 1)
|
Baseline (Day 1)
|
|
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Gait and Balance - Dynamic Gait Index
Prazo: Immediately after therapy completion (Day 10)
|
Immediately after therapy completion (Day 10)
|
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Gait Asymmetry - Wisconsin Gait Scale
Prazo: Baseline (Day 1)
|
The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
|
Baseline (Day 1)
|
|
Gait Asymmetry - Wisconsin Gait Scale
Prazo: Immediately after therapy completion (Day 10)
|
The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
|
Immediately after therapy completion (Day 10)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Agnieszka Guzik, Rzeszów, Al. Rejtana 16C, Poland 35-310
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Outros números de identificação do estudo
- 1/11/2025
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