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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
34
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mini-Balance Evaluations Systems Test
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Montreal Cognitive Assessment
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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Biodex Balance System
時間枠：Baseline and Week 8
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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)
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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Parkinson's Disease Questionnaire-39
時間枠：Baseline and Week 8
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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
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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Global Rating of Change Scale
時間枠：Post-intervention (Week 8)
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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
時間枠：Post-intervention (Week 8)
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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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協力者と研究者
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月20日
一次修了 (推定)
2027年6月30日
研究の完了 (推定)
2027年12月30日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月25日
QC基準を満たした最後の更新が送信されました
2026年6月23日
最終確認日
2026年6月1日
詳しくは
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