Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task
NCT07660978 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-06-25
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 DISEASE (Disorder)
- Parkinson Disease (PD)
- Parkinson s Disease
- Postural Instability
- Postural Instability Gait Disorders
- Gait Disorders
- Cognitive Dysfunction, Cognitive Disorder
Interventions
- OTHER
-
Dual Task Training (DTT)
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.
- OTHER
-
Virtual Reality Training (VRT)
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.
Sponsors & Collaborators
-
Bezmialem Vakif University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-20
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-30
More Related Trials
-
Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment
NCT01580787 ·Status: COMPLETED ·Phase: NA
-
Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease
NCT03686462 ·Status: COMPLETED ·Phase: NA
-
Comparison of Vestibular and Dual-Task Rehabilitation in Parkinson's Disease
NCT07277205 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Virtual Reality in Parkinson Disease
NCT02807740 ·Status: COMPLETED ·Phase: NA
-
Immersive Virtual Reality to Improve Gait in Parkinson's Disease
NCT03727529 ·Status: UNKNOWN ·Phase: NA
-
Virtual Reality on Balance of Parkinson's Disease
NCT07274514 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease
NCT03021408 ·Status: UNKNOWN ·Phase: NA
-
Virtual Reality Can be Used to Improve Balance Reducing Dynamic Falls in Those With Parkinson's Disease
NCT03406728 ·Status: UNKNOWN ·Phase: NA
-
Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in PD
NCT05385497 ·Status: COMPLETED ·Phase: NA
-
The Effects of Dual Task Training With Different Task Priorities on Physical Performance and Cognitive Status in Patients With Parkinson's Disease
NCT06794177 ·Status: COMPLETED ·Phase: NA
-
Effects of iVR Treadmill on Gait in PD
NCT04019158 ·Status: COMPLETED ·Phase: NA
-
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
NCT04117737 ·Status: COMPLETED ·Phase: NA
-
The Influence of Manual and Verbal Guidance for Therapeutic Results in People With Parkinson's Disease
NCT03774225 ·Status: UNKNOWN ·Phase: NA
-
Virtual Exercises in Patients With Parkinson's Disease.
NCT02023034 ·Status: COMPLETED ·Phase: NA
-
The Effects of Dual Task Training in Individuals With Parkinson's Disease
NCT02538029 ·Status: COMPLETED ·Phase: NA
-
Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease
NCT02516644 ·Status: UNKNOWN ·Phase: NA
-
Virtual Reality for Parkinson's Disease
NCT03637023 ·Status: TERMINATED ·Phase: NA
-
Effectiveness of Video-Based Upper Extremity Exercise Program in Parkinson's Disease
NCT06807411 ·Status: COMPLETED ·Phase: NA
-
Effect of Adding Computerized Cognitive Training on Balance, Locomotion and Cognition in Parkinson's Disease
NCT06104072 ·Status: RECRUITING ·Phase: NA
-
Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
NCT06133283 ·Status: COMPLETED ·Phase: NA
-
Effects of Home Rehabilitation of Balance Based on Functional Exercises in People With Parkinson's Disease
NCT04963894 ·Status: UNKNOWN ·Phase: NA
-
Dual-Task Balance and Gait Training Combined With Cognitive Training in Parkinson's Patients
NCT07213232 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Evaluating the Influence of Externally vs. Internally Focused Exercise on Rehabilitation in Parkinson's Disease
NCT02476240 ·Status: COMPLETED ·Phase: NA
-
Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
NCT04087031 ·Status: RECRUITING ·Phase: NA
-
Robot-assisted Gait Training in Patients With Parkinson's Disease
NCT03490578 ·Status: COMPLETED ·Phase: NA