Parkinson DiseaseNCT07250672
Patient-Specific 3D Action Observation Training in Parkinson's Disease
A study testing Patient-Specific VR Action Observation Training and Healthy-Model VR Action Observation Training in people with Parkinson Disease and Virtual Reality, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease, Virtual Reality, Action Obervation Training
- What is being tested?
- Patient-Specific VR Action Observation Training and Healthy-Model VR Action Observation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Abant Izzet Baysal University Faculty of Health Science
Bolu, Bolu, 14100
ENES T Benli, +905387359268, enestayyipbenli@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Virtual Reality, Action Obervation Training, Immersive Virtual Reality, 3d Recording
- Being tested
- Patient-Specific VR Action Observation Training, Healthy-Model VR Action Observation Training
- Keywords
- Parkinson, Virtual reality
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Specific VR Action Observation TrainingOther
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.
Healthy-Model VR Action Observation TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Specific VR Group | Experimental | Participants will undergo action observation training delivered in immersive virtual reality using their own 3D motion recordings. Receives: Other: Patient-Specific VR Action Observation Training |
| Healthy-Model VR Group | Active comparator | Participants will undergo action observation training delivered in immersive virtual reality using 3D recordings obtained from healthy individuals performing the same actions. Receives: Other: Healthy-Model VR Action Observation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Movement Rate (SMR
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).
Measured: At baseline and after completion of 6-week intervention period
Secondary outcomes (5)
Unified Parkinson's Disease Rating Scale (UPDRS)
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.
Measured: At baseline and after completion of 6-week intervention period
Nine-Hole Peg Test (NHPT)
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.
Measured: At baseline and after completion of 6-week intervention period
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
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.
Measured: At baseline and after completion of 6-week intervention period
Parkinson's Disease Questionnaire (PDQ-8)
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).
Measured: At baseline and after completion of 6-week intervention period
Intrinsic Motivation Inventory (IMI)
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.
Measured: After completion of 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Dec 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a randomized, parallel-group, interventional design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enes tayyip benli, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250672
- Sponsor's protocol ID
- AIBU-FTR-BENLI-009
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data (IPD) will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Action Observation Training Using Patient-Specific 3D Records in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT07250672
- Acronym / sponsor ID
- AIBU-FTR-BENLI-009
- Conditions
- Parkinson Disease, Virtual Reality, Action Obervation Training, Immersive Virtual Reality, 3d Recording
- Keywords
- Parkinson, Virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will use a randomized, parallel-group, interventional design.
| Arm | Type | Receives |
|---|---|---|
| Patient-Specific VR Group | Experimental | Other: Patient-Specific VR Action Observation TrainingParticipants will undergo action observation training delivered in immersive virtual reality using their own 3D motion recordings. |
| Healthy-Model VR Group | Active comparator | Other: Healthy-Model VR Action Observation TrainingParticipants will undergo action observation training delivered in immersive virtual reality using 3D recordings obtained from healthy individuals performing the same actions. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Specific VR Action Observation TrainingParticipants 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. | Other | Patient-Specific VR Group |
| Healthy-Model VR Action Observation TrainingParticipants 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. | Other | Healthy-Model VR Group |
Primary outcome
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).
5 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 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
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: 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
Intrinsic Motivation Inventory (IMI)
Time frame: After completion of 6-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. No, individual participant data (IPD) will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Specific VR Action Observation Training and Healthy-Model VR Action Observation Training in people with Parkinson Disease and Virtual Reality, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enes T Benli, Ph.D (+905387359268, enestayyipbenli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Movement Rate (SMR (time frame: At baseline and after completion of 6-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.