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| Name | Class |
|---|---|
| Universidad San Jorge | OTHER |
| Universidad de Zaragoza | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group. Immersive Virtual Reality Rehabilitation Program | Experimental | The participants in the experimental group will receive a immersive virtual reality rehabilitation program to improve static and dynamic balance and quality of life. |
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| Control Group. Standard Rehabilitation Program | Active Comparator | The participants in the control group will receive a standard physical therapy rehabilitation program to improve static and dynamic balance and quality of life |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive Virtual Reality Program | Other | The participants in the intervention group will receive a Immersive Virtual Reality Rehabilitation Program to improve static and dynamic balance and quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Balance-Mini-Balance Systems Test (Mini-BESTest) | 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 | Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2). |
| Measure | Description | Time Frame |
|---|---|---|
| Gait speed-10-Meter Walk Test (10MWT) | 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. | Gait speed will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Calvo, PhD | Universidad de Zaragoza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación de Parkinson de Aragón | Zaragoza | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41838745 | Derived | Morcillo-Martinez L, Sanz-Marmol M, Romanos-Navarrete AI, Calvo S, Le Roux-Etheve L, Esteban-Repiso L, Cordova-Alegre P, Jimenez-Sanchez C, Garay-Sanchez A, la Cruz NB. Effects of a level-based immersive virtual reality physical therapy program on static and dynamic balance in Parkinson's disease: Protocol for a randomized controlled trial. PLoS One. 2026 Mar 16;21(3):e0344457. doi: 10.1371/journal.pone.0344457. eCollection 2026. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Single-blind randomized clinical trial with two parallel interventions
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Single Blind (Outcomes Assessor)
| Standard Rehabilitation Program | Other | The participants in the control group will receive a Standard Physical Therapy Rehabilitation Program to improve static and dynamic balance and quality of life |
|
| Lower Limb Muscle Strength - 30 seconds Sit to Stand Test (30 CST) | 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 | 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). |
| Functional mobility during walking-Time up and Go (TUG) | Assess the functional mobility during walking, as well as the risk of falling | Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2). |
| Functional mobility performing a dual task-Time Up & Go Dual Task (TUG-DT): | 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) | 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). |
| Quality of life- Parkinson Disease Questionnaire-39 (PDQ-39 | 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. | Quality of life will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2). |
| Adverse symptoms- Simulator Sickness Questionnaire (SSQ) | 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. | Through intervention completion, an average of 1 month. |
| Adherence to the Immersive Virtual reality program | 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. | Through intervention completion, an average of 1 month. |
| Satisfaction with Immersive Virtual Reality Program | 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. | Satisfaction with Immersive Virtual Realiity program will be assessed at two time points: the day post-intervention (M1), and 90 days post-intervention (M2). |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |