NCT07250672

Brief 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. 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.

Trial Health

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Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
15mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Dec 2025Aug 2027

First Submitted

Initial submission to the registry

October 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

November 26, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

October 2, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

ParkinsonVirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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).

    At baseline and after completion of 6-week intervention period

Secondary Outcomes (5)

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    At baseline and after completion of 6-week intervention period

  • Nine-Hole Peg Test (NHPT)

    At baseline and after completion of 6-week intervention period

  • Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

    At baseline and after completion of 6-week intervention period

  • Parkinson's Disease Questionnaire (PDQ-8)

    At baseline and after completion of 6-week intervention period

  • Intrinsic Motivation Inventory (IMI)

    After completion of 6-week intervention period

Study Arms (2)

Patient-Specific VR Group

EXPERIMENTAL

Participants will undergo action observation training delivered in immersive virtual reality using their own 3D motion recordings.

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.

Other: Healthy-Model VR Action Observation Training

Interventions

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.

Patient-Specific VR Group

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.

Healthy-Model VR Group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University Faculty of Health Science

Bolu, Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Only the outcome assessor will be masked to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will use a randomized, parallel-group, interventional design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 2, 2025

First Posted

November 26, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

August 15, 2027

Last Updated

November 26, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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

Locations