NCT06147726

Brief Summary

Upper extremities are the first part of the body to be affected by Parkinson's disease. Although studies have shown that virtual reality-assisted rehabilitation methods are effective on gait and balance, studies on their use for upper extremity rehabilitation are limited. For this reason, the aim of the project is to examine whether virtual reality supported upper extremity position matching exercises, which will be specially prepared according to joint ranges of motion, will provide functional improvement in the upper extremities of individuals with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

September 27, 2023

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Box and Block Test (BBT)

    The Box and Block Test (BBT) is widely used in neurological rehabilitation to assess upper extremity motor function, gross manual dexterity, and coordination. The test apparatus consists of a partitioned box measuring 53.7 × 25.4 × 8.5 cm and 150 wooden cubes. During administration, the box is placed in front of the participant with the partition aligned to the midline. The participant is instructed to transfer the cubes from one compartment to the other using the test hand as quickly as possible. At the end of the trial, the therapist records the score by counting the number of cubes successfully transferred.

    through study completion, an average of 1 year

  • Proprioception Assessment

    Position, i.e. proprioceptive sensation, will be evaluated with the "angle repetition test", one of the methods commonly used in the clinic. The person will be positioned in a sitting position with his/her back unsupported and feet touching the floor. The angle repetition test will be performed with a mobile device fixed above the elbow and between the shoulder. The person's eyes will be closed during the assessment to prevent the learning effect and the use of visual reference. After the shoulder is brought to the reference angle, the person is allowed to perceive the angle by waiting 10 seconds. The person will then be asked to bring his/her shoulder to the side of his/her body and then repeat the taught reference angle as he/she perceived it. The absolute value of the angle deviated from the target will be recorded. Measurements in the shoulder joint will be made at 40° and 100° angles.

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Unified Parkinson's Disease Rating Scale

    through study completion, an average of 1 year

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire

    through study completion, an average of 1 year

  • Parkinson's Disease Questionnaire (PDQ-8)

    through study completion, an average of 1 year

  • Intrinsic Motivation Inventory (IMI)

    average 1 year after the completion of the study

Study Arms (2)

VR group

ACTIVE COMPARATOR

group to receive virtual reality supported upper extremity rehabilitation in addition to conventional physiotherapy

Other: Upper extremity position matching exercises in virtual realityOther: Conventional physiotherapy

Control group

ACTIVE COMPARATOR

The group that will receive conventional physiotherapy for the total treatment time of the VR group

Other: Conventional physiotherapy

Interventions

In addition to conventional treatment approaches for 20 minutes 2 days a week for 8 weeks, joint positioning exercises (4 different game sequences of 4 minutes, 1 minute rest between each sequence, total 20 minutes) designed specifically for the individual's existing range of motion will be applied to the VR group.

VR group

proprioceptive neuromuscular facilitation techniques, parkinson-specific upper extremity and balance and gait exercises

Control groupVR group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Accepting to participate in the research
  • Being diagnosed with Parkinson's Disease by a neurologist
  • Continuing anti-parkinsonian medication
  • Hoehn-Yahr (H-Y) stage 3 and below
  • Ability to walk independently
  • To have full range of motion in shoulder abduction and elbow extension movements

You may not qualify if:

  • Presence of additional neurological diseases other than Parkinson's Disease
  • Scores below 21 on the Montreal Cognitive Assessment Scale
  • Change in medication dosage in the last 1 month
  • Severe visual impairment or complete hearing impairment in both ears
  • Having a rheumatologic, musculoskeletal, etc. disease that may affect upper extremity functions
  • The occurrence of severe tremors or dyskinesias due to the end of the drug dose
  • Failing the Titmus butterfly test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ramazan Kurul, Ph.D

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the physiotherapist administering the treatment and the physiotherapist performing the assessments will be different people
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups, conventional physiotherapy to the control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2023

First Posted

November 28, 2023

Study Start

November 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 15, 2024

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations