Effects of Virtual Reality Based Games in Rehabilitation of Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Virtual Reality Based Games on Upper Extremities, Trunk and Cognitive Functions in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235880
• Other study ID #: KA-21067
• Status: Completed
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: September 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Parkinson's disease

• 50 years old and over

• Stage 1.5-3 according to the modified Hoehn-Yahr Staging Scale

• Mini mental test score of 24 and above

Exclusion Criteria:

• Additional neurological disease or symptom other than Parkinson's disease

• Orthopedic disorder that will prevent them from doing exercises

• Severe mental disorders

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Virtual reality based games
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.
• Conventional exercises
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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Dynamic balance with functional reach test	Functional reach test is frequently used to assess dynamic balance and fall risk. While the patient is standing by the wall, he/she raises his/her arm to 90 degrees and tries to reach as far as he/she can without taking his/her feet off the ground. Extending a longer distance indicates better balance and less risk of falling	Change from Baseline at 8 weeks
Secondary	Balance and mobility with Timed Up and Go Test	While the patient is in a sitting position, he/she is asked to stand up from the chair, walk 3 meters, turn around, come back and sit down, and the time is recorded. Doing it in less time demonstrates better balance and mobility	Change from Baseline at 8 weeks
Secondary	Quality of life with Parkinson's Disease Questionnaire	The 39-item Parkinson's Disease Questionnaire was developed to evaluate the quality of life of Parkinson's patients and has Turkish validity and reliability. Higher scores mean worse outcome.	Change from Baseline at 8 weeks
Secondary	Disease severity and symptoms with Unified Parkinson Disease Rating Scale Part 2 and 3	It is one of the most frequently used scales to evaluate the severity of the disease in Parkinson's patients. It evaluates many problems such as motor and non-motor problems, treatment complications, problems in daily living activities and consists of 4 sections. However, in our study, the 2nd and 3rd sections which evaluate motor problems and activities of daily living will be used. Higher scores mean worse outcome.	Change from Baseline at 8 weeks