NCT05235880

Brief Summary

The purpose of this study is to investigate the effects of virtual reality based games on upper extremities, trunk and cognitive functions in patients with Parkinson's Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

December 22, 2021

Last Update Submit

September 20, 2023

Conditions

Keywords

parkinson diseasephysiotherapyexergames

Outcome Measures

Primary Outcomes (4)

  • Upper extremities performance with 9 hole peg test

    The patient sits with a table in front of him/her and places 9 small wooden sticks on the surface with nine holes on them, takes them out again and lays them on his/her side. He/she is asked to do it as quickly as possible and his/her time is saved

    Change from Baseline at 8 weeks

  • Upper extremities performance with Minnesota Manual Dexterity Test

    It involves taking small disc-shaped objects, each of standard size, to different distances on the table in the shortest possible time and placing them in sequence, while the patient is in a sitting position with a table in front of him/her.

    Change from Baseline at 8 weeks

  • Cognitive Status with Montreal Cognitive Assessment

    its validity and reliability in Turkish have been established. The total score ranges from 0-30, and a higher score indicates a better cognitive status. Below 21 points indicates cognitive impairment.

    Change from Baseline at 8 weeks

  • Trunk Functions with Trunk Impairment Scale

    It is a valid and reliable scale for evaluating the motor disorders and balance of the trunk in Parkinson's patients. The total score in the scale, which consists of 17 items in 3 sections, ranges from 0 to 23. A higher score indicates better trunk function and balance.

    Change from Baseline at 8 weeks

Secondary Outcomes (4)

  • Dynamic balance with functional reach test

    Change from Baseline at 8 weeks

  • Balance and mobility with Timed Up and Go Test

    Change from Baseline at 8 weeks

  • Quality of life with Parkinson's Disease Questionnaire

    Change from Baseline at 8 weeks

  • Disease severity and symptoms with Unified Parkinson Disease Rating Scale Part 2 and 3

    Change from Baseline at 8 weeks

Study Arms (2)

study group

EXPERIMENTAL

1 hour physiotherapy session for 3 times a week and 8 weeks in total.

Other: Virtual reality based games

control group

ACTIVE COMPARATOR

1 hour physiotherapy session for 3 times a week and 8 weeks in total.

Other: Conventional exercises

Interventions

In an hour physiotherapy session first 40 minutes of session includes conventional physiotherapy program tailored to patient's needs. Last 20 minutes of session includes virtual reality based games aiming improvement on upper extremities, trunk and cognitive functions.

study group

In an hour physiotherapy session first 40 minutes of session includes conventional physiotherapy program tailored to patient's needs. Last 20 minutes of session includes conventional physiotherapy approaches aiming improvement on upper extremities, trunk and cognitive functions.

control group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Parkinson's disease
  • years old and over
  • Stage 1.5-3 according to the modified Hoehn-Yahr Staging Scale
  • Mini mental test score of 24 and above

You may not qualify if:

  • Additional neurological disease or symptom other than Parkinson's disease
  • Orthopedic disorder that will prevent them from doing exercises
  • Severe mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (6)

  • Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.

    PMID: 25904081BACKGROUND
  • Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.

    PMID: 18344392BACKGROUND
  • Abbruzzese G, Marchese R, Avanzino L, Pelosin E. Rehabilitation for Parkinson's disease: Current outlook and future challenges. Parkinsonism Relat Disord. 2016 Jan;22 Suppl 1:S60-4. doi: 10.1016/j.parkreldis.2015.09.005. Epub 2015 Sep 3.

    PMID: 26360239BACKGROUND
  • Allen NE, Song J, Paul SS, Smith S, O'Duffy J, Schmidt M, Love R, Sherrington C, Canning CG. An interactive videogame for arm and hand exercise in people with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2017 Aug;41:66-72. doi: 10.1016/j.parkreldis.2017.05.011. Epub 2017 May 15.

    PMID: 28528804BACKGROUND
  • Levin MF. Can virtual reality offer enriched environments for rehabilitation? Expert Rev Neurother. 2011 Feb;11(2):153-5. doi: 10.1586/ern.10.201. No abstract available.

    PMID: 21306202BACKGROUND
  • Cetin B, Kilinc M, Cakmakli GY. The effects of exergames on upper extremity performance, trunk mobility, gait, balance, and cognition in Parkinson's disease: a randomized controlled study. Acta Neurol Belg. 2024 Jun;124(3):853-863. doi: 10.1007/s13760-023-02451-3. Epub 2024 Jan 5.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gül Yalçın Çakmaklı, Assoc. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 22, 2021

First Posted

February 11, 2022

Study Start

April 15, 2022

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations