- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807411
Effectiveness of Video-Based Upper Extremity Exercise Program in Parkinson's Disease
Investigation of the Effectiveness of a Video-Based Exercise Program Targeting Upper Extremity Function in Individuals With Parkinson
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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, such as Nintendo Wii and Microsoft Kinect, are commonly used in VR systems. Video game-based training has emerged as a valid, cost-effective, and easily integrated adjunct to conventional therapy in neurorehabilitation, offering a safe and controlled environment for physical activity. However, some studies have reported limited effects, highlighting the need for further high-quality research to establish its effectiveness in neurological rehabilitation.
This study aims to evaluate the effects of a video-based game exercise program targeting the upper extremity in individuals with Parkinson's disease on joint range of motion (ROM), proprioception, functionality, postural instability due to kyphotic posture, and quality of life. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beykoz
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Istanbul, Beykoz, Turkey (Türkiye), 34810
- Istanbul Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 50-80 with idiopathic Parkinson's disease
- Hoehn and Yahr Scale Stage I to III
- Presence of kyphotic posture
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional exercise group
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. |
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).
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|
Experimental: Video game based exercise group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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.
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From enrollment to the end of treatment at 8 weeks
|
|
Joint position sense
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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.
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From enrollment to the end of treatment at 8 weeks
|
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Range of motion
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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.
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From enrollment to the end of treatment at 8 weeks
|
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Functionality
Time Frame: From enrollment to the end of treatment at 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Participants' quality of life will be assessed using the **Parkinson's Disease Questionnaire (PDQ-39)**.
The **PDQ-39** is a self-administered tool that demonstrates optimal psychometric properties and reflects the full spectrum of quality of life in individuals with Parkinson's disease.
The questionnaire consists of **39 items**.
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From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Burak Menek, PhD, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-2282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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