Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task
2026年6月23日 更新者：Bezmialem Vakif University
Effects of Cognitive-Based Balance Rehabilitation on Balance, Gait and Cognitive Functions in Parkinson's Disease Patients: Comparison of Virtual Reality and Dual Task
This prospective, randomized, single-blind, controlled clinical trial aims to evaluate and compare the efficacy of cognitive-based balance rehabilitation delivered via immersive Virtual Reality (VR) versus traditional Dual-Task Training (DTT) on balance, gait, cognitive functions, and quality of life in patients with Parkinson's Disease (PD).
Postural instability and cognitive decline are hallmark features of progressive PD that significantly elevate fall risks and compromise daily independence, yet conventional pharmacological therapies offer limited effectiveness in restoring complex postural control.
Given that motor and cognitive processes are intrinsically linked, this study addresses a critical gap in neurorehabilitation by investigating two contemporary modalities designed to challenge these systems simultaneously.
A total of 34 participants diagnosed with PD (aged 40-80 years, Hoehn and Yahr stages I-III) will be randomly allocated to either the Dual-Task Group (DTG), receiving structured therapeutic exercises integrated with sequential cognitive tasks, or the Virtual Reality Group (VRG), engaging in an immersive balance program utilizing the Oculus Quest 2® headset with the FIT-XR application.
Both groups will undergo an identical intervention protocol consisting of 45-minute supervised sessions, conducted twice weekly for 8 consecutive weeks during their pharmacological "on" phase.
Standardized assessments will be performed by a blinded clinician at baseline and post-intervention (Week 8).
The primary outcome measures will be dynamic balance and gait assessed through the Mini-Balance Evaluations Systems Test (Mini-BESTest) alongside global cognitive performance measured via the Montreal Cognitive Assessment (MoCA).
Secondary outcomes will encompass objective posturographic indices using the Biodex Balance System, motor severity via the Unified Parkinson's Disease Rating Scale (UPDRS-III), freezing of gait, health-related quality of life, global perceived improvement, and potential cyber-sickness symptoms monitored through the Virtual Reality Sickness Questionnaire (VRSQ) to comprehensively determine the safety and comparative therapeutic value of these interventions.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
34
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Diagnosed with Parkinson's Disease by a neurologist.
- Hoehn & Yahr Stage I-III.
- Aged between 40-80 years.
- Literate and capable of performing basic mathematical calculations.
- Montreal Cognitive Assessment≥21
- Stable pharmacological treatment.
- Physician's approval for exercise participation.
Exclusion Criteria:
- Currently participating in another exercise or drug trial.
- Presence of any additional neurological disorders.
- Significant musculoskeletal disorders, arthritis, or cardiovascular disease.
- Uncontrolled epilepsy or severe orthostatic hypotension.
- Engaged in regular moderate-intensity exercise more than once a week in the last 6 months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Dual Task Group
Participants in this group will undergo a supervised, structured therapeutic exercise program specifically designed for balance and postural control, which will be integrated with concurrent, increasingly complex cognitive tasks (such as counting backward, calculation, or memory retrieval).
The intervention will consist of 45-minute sessions held twice a week for 8 consecutive weeks, totaling 16 sessions.
All exercises will be conducted by a physiotherapist during the patients' pharmacological 'on' phase.
|
A supervised physical therapy program consisting of motor balance and postural control exercises executed simultaneously with secondary cognitive tasks.
The physical component includes progressive static and dynamic balance training, functional gait training, and coordination exercises.
The concurrent cognitive tasks involve backward counting, mental arithmetic, and working memory retrieval.
The intervention is delivered in 45-minute sessions, twice a week for 8 weeks (16 sessions total) by a certified physiotherapist.
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有源比较器：Virtual Reality Group
Participants in this group will engage in an immersive Virtual Reality (VR) balance rehabilitation program utilizing the Oculus Quest 3® headset.
They will play the clinically validated FIT-XR application, which is tailored to target upper and lower extremity coordinate functions and dynamic balance.
The exercise intensity, session duration (45 minutes), and frequency (twice a week for 8 weeks, totaling 16 sessions) will be identical to the Dual Task Group.
Sessions will be supervised by a physiotherapist during the patients' pharmacological 'on' phase, with full safety protocols implemented to prevent fall risks.
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An immersive virtual reality rehabilitation program utilizing the Oculus Quest 3® VR headset.
Participants engage in motion-based exercises within the clinically validated FIT-XR software application, specifically targeting multi-directional reaching, stepping, upper and lower limb coordination, and dynamic weight shifting.
The exercise intensity, session duration (45 minutes), and frequency (twice weekly for 8 weeks, 16 sessions total) are tightly matched to the Dual Task Group.
All sessions are fully supervised by a physiotherapist with standard safety measures.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mini-Balance Evaluations Systems Test
大体时间：Baseline and Week 8
|
A 14-item clinical rating scale specifically focused on dynamic gait and postural control across four domains: anticipatory postural adjustments, reactive postural responses, sensory orientation, and dynamic gait.
Each item is scored on a scale from 0 (unable to perform) to 2 (normal performance).
The total score ranges from 0 to 28, where higher scores indicate better dynamic balance and superior postural performance.
|
Baseline and Week 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Montreal Cognitive Assessment
大体时间：Baseline and Week 8
|
A 30-point screening instrument designed to detect mild cognitive impairment and dementia by evaluating short-term memory, visuospatial abilities, executive function, language, attention, concentration, working memory, and orientation.
The total score ranges from 0 to 30, with higher scores indicating better global cognitive function.
|
Baseline and Week 8
|
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Biodex Balance System
大体时间：Baseline and Week 8
|
Postural stability (anterior-posterior stability index, mediolateral stability index, general stability index), fall risk index, and limits of stability will be assessed using the Biodex Balance System.
Higher scores on stability indices indicate poorer postural stability, while higher scores on limits of stability indicate better postural control.
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Baseline and Week 8
|
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Unified Parkinson's Disease Rating Scale - Part III (Motor Examination)
大体时间：Baseline and Week 8
|
A comprehensive clinical rating scale used to evaluate the severity of motor symptoms in Parkinson's disease.
Part III involves the objective motor examination.
Each item is scored from 0 (unaffected) to 4 (most severely affected), yielding a total score ranging from 0 to 108.
Higher scores indicate greater disease severity and more pronounced motor impairment.
|
Baseline and Week 8
|
|
Parkinson's Disease Questionnaire-39
大体时间：Baseline and Week 8
|
A 39-item self-administered, disease-specific health status instrument evaluating quality of life across 8 dimensions.
Each item is scored on a scale from 0 (never) to 4 (always).
Individual dimension scores and the global index are standardized to range from 0 to 100.
Higher scores indicate worse quality of life (more frequent difficulties), while lower scores reflect better health status.
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Baseline and Week 8
|
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Freezing of Gait Questionnaire
大体时间：Baseline and Week 8
|
A 6-item self-report questionnaire designed to evaluate the severity of freezing of gait and its impact on walking performance.
It includes 4 items on freezing severity and 2 items on general walking difficulty, with each item scored from 0 to 4. The total score ranges from 0 to 24, where higher scores indicate more severe freezing of gait and a greater negative impact on gait performance.
|
Baseline and Week 8
|
|
Global Rating of Change Scale
大体时间：Post-intervention (Week 8)
|
A 5-point Likert scale used to measure participants' subjective perception of overall health change and treatment satisfaction over the course of the study.
Total scores range from -2 to +2, where -2 represents "much worse", 0 represents "the same", and +2 represents "much better".
Higher scores indicate greater perceived improvement and higher treatment satisfaction.
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Post-intervention (Week 8)
|
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Virtual Reality Sickness Questionnaire
大体时间：Post-intervention (Week 8)
|
A 9-item self-report questionnaire assessing general oculomotor discomfort and disorientation following the virtual reality intervention.
Items are scored using a 4-point Likert scale from 0 (none) to 3 (severe).
The total score ranges from 0 to 27, where higher scores indicate worse and more severe cyber-sickness symptoms.
This measure is evaluated only for the Virtual Reality Group.
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Post-intervention (Week 8)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月20日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2027年12月30日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月23日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.