- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07587554
Effects of Wiifit vs Conventional Vestibular Rehabilitation on Dizziness and Balance in Patients With Unilateral Peripheral Vestibular Dysfunction
Unilateral Peripheral Vestibular Dysfunction (UPVD) causes dizziness, imbalance, vertigo, and reduced quality of life.
Conventional Vestibular Rehabilitation Therapy (cVRT) is effective, while WiiFit-based virtual reality training may further enhance motivation and neuroplasticity.
This study aims to compare WiiFit-based training with conventional rehabilitation in improving balance and reducing dizziness in UPVD patients.
A randomized controlled trial will include participants aged 18-65 meeting specific inclusion and exclusion criteria.
Participants will be randomly divided into two groups: Group A receiving conventional therapy (40 minutes, 3 sessions/week) and Group B receiving WiiFit-based exercises for 4 weeks.
Outcomes will be assessed using DHI, Mini-BESTest, and VADL before and after intervention.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Unilateral Peripheral Vestibular Dysfunction (UPVD) is a common vestibular disorder resulting in symptoms such as dizziness, imbalance, vertigo, and postural instability.
These symptoms significantly affect patients' daily functioning and quality of life. Conventional Vestibular Rehabilitation Therapy (cVRT), including gaze stabilization, balance training, and habituation exercises, has proven effective in reducing dizziness and improving balance.
However, newer approaches like virtual reality-based rehabilitation using WiiFit offer interactive, task-oriented, and engaging exercises that may enhance motivation and neuroplasticity, potentially leading to better outcomes.This study aims to compare the effectiveness of WiiFit-based vestibular training and conventional vestibular rehabilitation in improving balance and reducing dizziness in patients with UPVD.
The objective is to determine whether the addition of a virtual reality component can yield superior clinical outcomes compared to traditional therapy.
A randomized controlled trial will be conducted on participants diagnosed with UPVD selected through purposive sampling.
Participants aged 18-65 years, confirmed positive on the Head Thrust Test, experiencing persistent dizziness or imbalance for more than four weeks, able to walk independently, and scoring above 12 on the Vertigo Symptom Scale will be included.
Individuals with central vestibular disorders, active BPPV, severe visual or musculoskeletal impairments, seizure history, current participation in other vestibular rehabilitation programs, or severe cervical spine disease will be excluded.
Eligible participants will be randomly assigned into two equal groups using a computer-generated sequence.
Group A will receive conventional vestibular rehabilitation that includes exercises like foam surface standing, VORx1 and 2 training, tandem walking, side shuffles each for a session of 40 mins with a total of 3 sessions per week.
Group B will receive WiiFit-based vestibular rehabilitation exercises like ski salom, soccer heading, table tilt, penguin slide, obstacle course using the Nintendo WiiFit balance board for 4 weeks.
Outcome measures, including the Dizziness Handicap Inventory (DHI), Mini-BESTest, and Vestibular Activities of Daily Living Scale (VADL), will be assessed pre- and post-intervention to evaluate changes in dizziness and functional balance.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Islamabad, Paquistão, 44000
- Foundation University College of Physical Therapy
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 18-65 years
- Diagnosed with UPVD (confirmed via Positive Head Thrust Test)
- Experiencing persistent dizziness or imbalance for >4 weeks after acute onset
- Able to stand and walk independently
- VSS total score >12
Exclusion Criteria:
- Central vestibular disorders (e.g., stroke, multiple sclerosis)
- Active BPPV (confirmed by Dix-Hallpike Test)
- Severe visual or MSK impairments affecting balance
- History of epileptic seizures or motion sickness triggered by video games
- Participation in other vestibular rehab programs during study period -- Diagnosed with severe cervical spine disease
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 |
|---|---|
|
Comparador Ativo: Vestibular Rehabilitation Therapy
Participants in the control group will undergo standard vestibular rehabilitation therapy, which includes gaze stabilization, habituation, and balance retraining activities. The program will consist of three sessions weekly, spanning four consecutive weeks, with each session lasting around 30 to 40 minutes. Exercises will start in a sitting posture and gradually move to standing and dynamic balancing activities, customized to the patient's tolerance and safety. Following exercises will be administered: Week 1:
Week 2:
Week 3:
Week 4:
|
Participants in the control group will undergo standard vestibular rehabilitation therapy, which includes gaze stabilization, habituation, and balance retraining activities.
The program will consist of three sessions weekly, spanning four consecutive weeks, with each session lasting around 30 to 40 minutes.
Exercises will start in a sitting posture and gradually move to standing and dynamic balancing activities, customized to the patient's tolerance and safety.
To mitigate danger, sessions will occur in a peaceful, organized environment with supportive aids (e.g.
chair or wall) accessible.
Safety standards will encompass a pre-session fall risk assessment and therapist oversight, while any adverse events will be recorded and addressed under physician consultation.
|
|
Experimental: Wii Fit Vestibular Training
Participants in the experimental group will undergo vestibular training using the Wii Fit on the Nintendo Wii balance platform. Sessions will include interactive balance tasks targeting postural control, coordination, and visual-vestibular integration. Training will be conducted three times per week for four weeks, with each session lasting approximately 30 minutes and progressively advancing from basic to more complex activities based on participant performance and safety. Real-time feedback from the Wii system will be used to enhance motivation, adherence, and engagement. Week 1 will include Table Tilt (basic) and Soccer Heading (10 min each with 5 min warm-up and 5 min cool-down). Week 2 will include Balance Bubble, Bowling, and Ski Slalom (slow), 10 min each with warm-up and cool-down. Week 3 will include Obstacle Course (basic), Table Tilt (advanced), and Penguin Slide, 10 min each. Week 4 will involve a combination of all games, 5 min each with 2-3 min rest intervals. |
Participants in the experimental group will engage in vestibular training via the Wii Fit on the Nintendo Wii balancing platform.
Sessions will include interactive balancing activities aimed at challenging postural control, coordination, and visual-vestibular integration.
Training will consist of three sessions each week over four weeks, with each session lasting about 30 minutes, progressively increasing from fundamental to more intricate activities based on participant performance and safety considerations.
Real-time feedback from the Wii system will be utilized to improve motivation, adherence, and task engagement.
Safety measures will encompass therapist oversight at all times, the prevention of abrupt head movements or visual distractions during initial phases, and the delivery of both written and vocal directives to avert falls.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceived effects of dizziness
Prazo: 4 weeks
|
Dizziness Handicap Inventory (DHI) is a 25-item self-administered questionnaire intended to assess the perceived effects of dizziness on an individual's everyday activities.
Values vary from 0 (no handicap) to 100 (highest handicap), with increasing values signifying more incapacity interpretation: 16-34- mild impairment 36-52- moderate impairment 52+ - severe impairment
|
4 weeks
|
|
Dynamic Balance
Prazo: 4 weeks
|
The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a performance-based instrument designed to evaluate dynamic balance. The assessment comprises 14 items rated on a 3-point scale (0 = severe impairment to 2 = normal), yielding a maximum total score of 28. interpretation: 28- normal 20-22- minor balance impairment Below 20- significant fall risk |
4 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
disability in adults with vestibular dysfunction
Prazo: 4 weeks
|
The Vestibular Disorders Activities of Daily Living Scale (VADL) 1-2 = independent (normal) 3-5= independent with difficulty (mild) 6-8= dependent on others( moderate) 8-10= unable to participate in activity (severe)
|
4 weeks
|
Colaboradores e Investigadores
Patrocinador
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
- FUI/FUCP/CTR/Neuro/Wania
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 .