Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task

NCT07660978 | Not Yet Recruiting

• 1 other identifier: E-35700536-108.99-176309
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson s Disease; Gait Disorders; Parkinson Disease (PD); Postural Instability Gait Disorders; PARKINSON DISEASE (Disorder); Postural Instability; Cognitive Dysfunction, Cognitive Disorder

Keywords

Parkinson Disease; Postural Instability; Gait Disorders; Cognitive Dysfunction; Dual Task; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Mini-Balance Evaluations Systems Test

  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

Secondary Outcomes (7)

• Montreal Cognitive Assessment

  Baseline and Week 8

• Biodex Balance System

  Baseline and Week 8

• Unified Parkinson's Disease Rating Scale - Part III (Motor Examination)

  Baseline and Week 8

• Parkinson's Disease Questionnaire-39

  Baseline and Week 8

• Freezing of Gait Questionnaire

  Baseline and Week 8

Study Arms (2)

Dual Task Group

ACTIVE COMPARATOR

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.

Other: Dual Task Training (DTT)

Virtual Reality Group

ACTIVE COMPARATOR

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.

Other: Virtual Reality Training (VRT)

Interventions

Dual Task Training (DTT) OTHER

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.

Dual Task Group

Virtual Reality Training (VRT) OTHER

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.

Virtual Reality Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06