Patient-Specific 3D Action Observation Training in Parkinson's Disease

May 6, 2026 updated by: enes tayyip benli, Abant Izzet Baysal University

Examining the Effect of Action Observation Training Using Patient-Specific 3D Records in Parkinson's Patients

Although studies exist demonstrating the effects of single-session action observation training on bradykinesia in patients with Parkinson's disease, research investigating the long-term application of such training remains limited. Furthermore, the broader literature indicates that action observation training has typically been conducted in simulated environments or by using recordings obtained from healthy individuals. The aim of the present study is to examine the effects of action observation training, delivered in a fully immersive virtual reality environment using each patient's own 3D motion recordings, on bradykinesia and other disease-related parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Action observation training has been applied across diverse populations to improve performance and treat pathological conditions. Considering that bradykinesia tends to manifest more prominently in rhythmic movements, studies in healthy individuals have shown that merely observing rhythmic actions can influence spontaneous finger movement speed and lead to changes in motor performance, thereby paving the way for the use of action observation in addressing bradykinesia. In a study investigating the effects of action observation in patients with Parkinson's disease, observing fast rhythmic finger movements was reported to increase spontaneous finger movement speed, and compared with acoustic training, the effect of action observation persisted longer over time. Research on imagery through action observation further indicates that immersive virtual reality headsets, compared to monitor screens, facilitate the development of more distinct spatial rhythmic patterns in the brain. This evidence supports the use of fully immersive VR headsets instead of non-immersive monitor-based systems in action observation training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Bolu
      • Bolu, Bolu, Turkey (Türkiye), 14100
        • Recruiting
        • Abant Izzet Baysal University Faculty of Health Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary agreement to participate in the study
  • Clinical diagnosis of Parkinson's disease confirmed by a neurologist
  • Ongoing treatment with antiparkinsonian medication
  • Hoehn and Yahr (H-Y) stage ≤ 3
  • Ability to walk independently

Exclusion Criteria:

  • Presence of additional neurological disorders other than Parkinson's disease
  • Change in medication dosage within the past month
  • Score of ≥ 10 on the Simulator Sickness Questionnaire
  • Presence of amblyopia, strabismus, or pathologies impairing focus, depth perception, or normal 3D vision
  • Failure on the butterfly test of the Titmus stereotest (greater than 3,552 seconds of arc)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient-Specific VR Group
Participants will undergo action observation training delivered in immersive virtual reality using their own 3D motion recordings.
Other: Patient-Specific VR Action Observation Training
Participants will receive immersive VR action observation training using their own 3D motion recordings captured with an Insta360 camera (Arashi Vision Inc., Shenzhen, China). In Parkinson's patients, only the initial movement sequences without bradykinetic slowing will be selected, and these will be extended to the desired duration using loop playback or ping-pong loop playback in the device's proprietary software. The action observation protocol will consist of the following one-minute tasks: (1) total finger abduction and adduction, (2) fist making and opening, (3) wrist flexion and extension, (4) forearm pronation and supination, and (5) rhythmic striking of the dorsal and palmar surfaces of one hand against the palm of the other. A 1-minute rest will be given between each video. Training will be provided in addition to conventional therapy (35 minutes, 3 days per week for 6 weeks) tailored to individual needs.
Active Comparator: Healthy-Model VR Group
Participants will undergo action observation training delivered in immersive virtual reality using 3D recordings obtained from healthy individuals performing the same actions.
Other: Healthy-Model VR Action Observation Training
Participants will receive immersive VR action observation training using 3D video recordings of the same activities performed by healthy individuals, captured with an Insta360 camera (Arashi Vision Inc., Shenzhen, China). Recordings will not require editing or adjustments. The action observation protocol will consist of the same one-minute tasks: (1) total finger abduction and adduction, (2) fist making and opening, (3) wrist flexion and extension, (4) forearm pronation and supination, and (5) rhythmic striking of the dorsal and palmar surfaces of one hand against the palm of the other. A 1-minute rest will be given between each video. Training will be provided in addition to conventional therapy (35 minutes, 3 days per week for 6 weeks) tailored to individual needs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spontaneous Movement Rate (SMR
Time Frame: At baseline and after completion of 6-week intervention period
In this study, kinematic parameters of finger movements will be determined from video recordings. A commercial motion analysis software will be used to extract the coordinates of manually marked tracking points, which will then be transferred into tabular form for analysis. To improve the accuracy of marking and tracking, participants will wear fingertip gloves in different colors.The spontaneous movement rate will be calculated from video-recorded finger-tapping tasks. Each cycle consists of a touch duration (TD) and an inter-tapping interval (ITI). SMR will be defined as the inverse of the total duration of one tapping cycle (TD + ITI) and expressed in Hertz (Hz).
At baseline and after completion of 6-week intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: At baseline and after completion of 6-week intervention period
Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS), the most commonly used valid and reliable instrument for evaluating impairments and disabilities in Parkinson's disease.
At baseline and after completion of 6-week intervention period
Nine-Hole Peg Test (NHPT)
Time Frame: At baseline and after completion of 6-week intervention period
The Nine-Hole Peg Test is a performance-based assessment of manual dexterity. Before the test begins, participants will be instructed and shown how to perform the task once. They will then be asked to pick up the pegs one by one, place them into the holes, and after filling all holes, remove them one by one and place them back into the container.
At baseline and after completion of 6-week intervention period
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time Frame: At baseline and after completion of 6-week intervention period
The Disabilities of the Arm, Shoulder and Hand Questionnaire is a 30-item instrument used to evaluate upper extremity function and the impact of upper limb problems on daily activities. The first 21 items assess the degree of difficulty in performing various daily activities with the dominant extremity over the past week. The next 5 items assess the severity of pain, numbness, and weakness experienced during activities. The final 4 items evaluate the impact of upper limb pathology on sleep, work, social life, and psychological status.
At baseline and after completion of 6-week intervention period
Parkinson's Disease Questionnaire (PDQ-8)
Time Frame: At baseline and after completion of 6-week intervention period
Quality of life in Parkinson's disease will be assessed using the Parkinson's Disease Questionnaire (PDQ-39), a disease-specific instrument consisting of 39 items across eight domains: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (3 items), social support (3 items), cognition (4 items), communication (3 items), and bodily discomfort (4 items). To reduce participant burden, the PDQ-8, a short form including one representative item from each domain, may also be used. Items in the PDQ-8 evaluate the patient's status over the past month and are scored on a 5-point scale ranging from 0 (never) to 4 (always).
At baseline and after completion of 6-week intervention period
Intrinsic Motivation Inventory (IMI)
Time Frame: After completion of 6-week intervention period
The Intrinsic Motivation Inventory (IMI) is a multidimensional questionnaire used to assess participants' motivation and satisfaction while performing a given activity. It evaluates several domains, including interest/enjoyment, perceived competence, pressure/tension, perceived choice, and value/usefulness.
After completion of 6-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIBU-FTR-BENLI-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, individual participant data (IPD) will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings