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Recruiting NCT07250672

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

No phase Interventional Parkinson Disease Virtual Reality Action Obervation Training Immersive Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient-Specific VR Action Observation Training, Healthy-Model VR Action Observation Training.
Who it may be relevant to
Registry conditions: Parkinson Disease, Virtual Reality, Action Obervation Training, Immersive Virtual Reality. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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:
  • 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) r

Primary outcome measures

  • Spontaneous Movement Rate (SMR [Time frame: At baseline and after completion of 6-week intervention period]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Abant Izzet Baysal University Faculty of Health Science — Bolu

Identifiers

NCT: NCT07250672 · AIBU-FTR-BENLI-009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗