Asociación de Parkinson de Aragón
Zaragoza, Spain
NCT Number: NCT07274514
This study, titled: Effectiveness of immersive virtual reality on balance in people with Parkinson's disease. Is a randomized clinical trial conducted at Zaragoza Parkinson's Association in Spain. It aims to evaluate the effectiveness of a immersive virtual reality program in enhancing balance for patients with Parkinson.s disease (PD). PD is a neurodegenerative disease that has a major impact on patients' balance and gait, affecting their quality of life. Physical rehabilitation is crucial for maintaining and improving balance, and immersive virtual reality promises to be an alternative for improving outcomes in patients with PD.
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Notify Me55 year–90 year
All sexes
Interventional
Not applicable
Zaragoza, Spain
Study Backgroud and Rationale: Parkinson's disease (PD) is one of the most common neurogenerative disease. Parkinson's disease is one of the most common neurodegenerative diseases. Patients suffering from it present a series of motor symptoms, including resting tremors, hyperresistance, bradykinesia, postural instability, and gait disturbances. Postural instability leads to an increase in the number of falls, which leads to greater dependence and social isolation, resulting in a reduced quality of life. Usual physical therapy techniques show an improvement in the motor skills of people with PD; however, their effectiveness is sometimes limited by patient adherence. Objective: The primary objective of this study is to determine whether the Immersive Virtual Reality (IVR) program rehabilitation can improve the balance of people with PD by Mini-Balance Systems Test (Mini-BESTest). Secondary objectives included assessing changes in gait speed, lower limbs strength, functional mobility, quality of life, adherence to the treatment and the possible occurrence of adverse symptoms during the use of IVR. Study Design: This is a single-blind, randomized clinical trial. Fifty patients with PD will be recruited and randomly assigned to either the control group, wich will receive balance conventional physiotherapy rehabilitation thought or the intervention group, wich will receive a IVR program rehabilitation. Both groups will undergo a comprehensive rehabilitation program that will include: active mobility exercises, strength exercises for the main antigravity muscles, and active stretching of the main muscles of the posterior chain. Methodology: There will be eight 40-minute sessions over four weeks. The first 20 minutes will be the same for both groups, while the second part of the session will vary between the control group (standard physical therapy) and the intervention group (IVR).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants in the intervention group will receive a Immersive Virtual Reality Rehabilitation Program to improve static and dynamic balance and quality of life
The participants in the control group will receive a Standard Physical Therapy Rehabilitation Program to improve static and dynamic balance and quality of life
Time frame: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
The primary outcome is the improvement in balnace, which will be evaluated using the Mini-Balance Systems Test (Mini-BESTest). This test assesses static and dynamic balance disorders and determines the risk of falling by evaluating 14 items divided into 4 categories: anticipatory, reactive postural control, sensory orientation and dynamic gait. recovery.static and dynamic balance disorders and determines the risk of falling
Time frame: Gait speed will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Evaluate improvements in gait speed using the 10 meters walk test (10=MWT). The aim is to determine whether the immersive virtual reality program can enhance gait speed as compared to the usual physiotherapy approach.
Time frame: Lower Limb Muscle Strength will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Evaluate lower limb muscle strength using the 30 seconds sit-to-stand test (30CST). This assessment will provide data on the effectiveness of the immersive virtual reality program in improving lower extremity muscle strength
Time frame: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Assess the functional mobility during walking, as well as the risk of falling
Time frame: Functional mobility performing a dual task will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Asses functional mobility during walking, as well as the risk of falling while performing a dual task with Time Up and Go Dual Task (TUG-DT)
Time frame: Quality of life will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
Assess health-related quality of life in people with PD. This self-administered questionnaire consists of 39 items, divided into eight dimensions (mobility, activities of daily living,emotional well-being,stigma, social support, cognition, comunication, bodily discomfort.
Time frame: Through intervention completion, an average of 1 month.
Assess the occurrence of adverse symptoms during the Immersive Virtual Reality Program using the Simulator Sickness Questionnaire (SSQ). This questionnaire consists of 16 items divided into three sections: Oculomotor Function, Nausea, and Disorientation.
Time frame: Through intervention completion, an average of 1 month.
Evaluate compliance with the immersive virtual reality program by monitoring the percentage of sessions completed by participants. The compliance rate will be calculated as the number of sessions completed relative to the total number of program sessions.
Time frame: Satisfaction with Immersive Virtual Realiity program will be assessed at two time points: the day post-intervention (M1), and 90 days post-intervention (M2).
Evaluate participant satisfaction with the immersive virtual reality program using a standardized ad hoc questionnaire on a 5- point Likert scale, scored of 1 to 5, with higher scores indicating greater satisfaction.
Instituto de Investigación Sanitaria Aragón
Other
Effects of Immersive Virtual Reality on Balance of Parkinson's Disease
Acronym: RVI-PD
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