NCT06807411

Brief Summary

Over the past decade, virtual reality (VR) has been widely recognized as a therapeutic tool that enables neurological patients to interact with simulated environments through multiple sensory channels. Various sensors can be used in VR systems, with Nintendo Wii and Microsoft Kinect being the most popular. Video game-based training, grounded in VR technology, has emerged as a valid, cost-effective, and easily integrated adjunct to conventional therapy in neurorehabilitation. Compared to traditional exercise methods, video game training offers advantages by allowing users to perform physical activities in a safe and controlled environment. However, some studies have reported limited effects, emphasizing the need for more high-quality research to establish the effectiveness of interactive video games in neurological rehabilitation. This study aims to investigate the effects of a video-based game exercise program targeting the upper extremity in individuals with Parkinson's disease on joint range of motion, proprioception, functionality, postural instability due to kyphotic posture, and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

January 29, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

parkinsonexergameserious gameexercisephysiotherapy

Outcome Measures

Primary Outcomes (4)

  • Balance

    The Becure Balance System will be used to assess participants' postural stability. During this measurement, the participant will be asked to place both feet on the Balance Board and maintain balance for 15 seconds. Throughout this period, the participant's sway movements will be recorded.

    From enrollment to the end of treatment at 8 weeks

  • Joint position sense

    The Becure Extremity ROM device will be used to assess proprioception in participants at 30° and 60° shoulder flexion and abduction positions. Participants will first be asked to raise their shoulder to a specified angle, then replicate the same angle with their eyes closed. The angle values recorded with eyes open and closed will be compared, and the difference between the shoulder angles will be calculated.

    From enrollment to the end of treatment at 8 weeks

  • Range of motion

    joint range of motion (ROM) will be assessed using the Becure Extremity ROM system. This system utilizes built-in cameras and sensors to detect reference points during extremity movements, allowing for an objective measurement of joint ROM. In the Becure Extremity ROM assessment, the participant will stand in front of the camera and perform the required movement. Shoulder joint ROM, including flexion, extension, abduction, internal rotation, and external rotation, will be measured in degrees using this system.

    From enrollment to the end of treatment at 8 weeks

  • Functionality

    Participants' upper extremity functionality will be assessed using the DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire. DASH is designed to measure physical disability and symptoms in individuals with upper extremity disorders (hand, wrist, elbow, and shoulder). It is a 30-item scale that evaluates difficulties in performing various physical activities requiring upper extremity function.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

  • Parkinson's Disease Questionnaire (PDQ-39)

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Conventional exercise group

ACTIVE COMPARATOR

Participants in the conventional exercise group will undergo 24 sessions over 8 weeks (3 days per week, 30-minute sessions). The program will include: Stretching, strengthening, balance, gait, and posture exercises for the trunk and extremities. Kyphosis prevention exercises, including pectoral stretching, back extensor strengthening, and trunk mobilization. Resistance training using sandbags, dumbbells, and elastic bands. Tandem walking, weight-shifting on a balance board, and Frenkel coordination exercises. Each exercise will be performed for 15 repetitions, while stretching exercises will follow a 20-second stretch and 20-second rest protocol. Progression will be customized based on the participant's condition.

Other: Conventional exercise

Video game based exercise group

EXPERIMENTAL

Participants will be randomly assigned to either a conventional exercise group or a video-based game exercise group. All participants will receive conventional therapy for 8 weeks, 3 days per week, with 30-minute sessions (24 sessions in total). The video-based game exercise group will undergo the same conventional therapy, with an additional video game-based exercise program using the Becure Extremity ROM device under physiotherapist supervision. The program will include KinectPong, KinectBalloon, ArmRotate, and Uball games. Balance, joint position sense, ROM, functionality, and quality of life parameters will be assessed before and after treatment.

Other: Video game based exercise

Interventions

Participants in the conventional exercise group will receive a total of 24 sessions of conventional therapy over 8 weeks (3 days per week, 30-minute sessions).

Conventional exercise group

The video-based game exercise group will undergo the same conventional therapy, with an additional video game-based exercise program using the Becure Extremity ROM device under physiotherapist supervision. The program will include KinectPong, KinectBalloon, ArmRotate, and Uball games. Balance, joint position sense, ROM, functionality, and quality of life parameters will be assessed before and after treatment.

Video game based exercise group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 50-80 with idiopathic Parkinson's disease
  • Hoehn and Yahr Scale Stage I to III
  • Presence of kyphotic posture

You may not qualify if:

  • Presence of any other neurological condition
  • Any pathology affecting the movement system in addition to Parkinson's disease
  • Visual abnormalities
  • Cardiovascular conditions that may interfere with treatment
  • Dyskinesia
  • History of surgery for Parkinson's disease
  • Inability to cooperate at a level required to play the games

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Burak Menek, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

February 3, 2025

Primary Completion

July 5, 2025

Study Completion

July 12, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations