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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality based games
Conventional exercises
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson disease, physiotherapy, exergames

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

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
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
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.
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.

Full Information

First Posted
December 22, 2021
Last Updated
September 20, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05235880
Brief Title
Effects of Virtual Reality Based Games in Rehabilitation of Parkinson's Disease
Official Title
Effects of Virtual Reality Based Games on Upper Extremities, Trunk and Cognitive Functions in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson disease, physiotherapy, exergames

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
1 hour physiotherapy session for 3 times a week and 8 weeks in total.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
1 hour physiotherapy session for 3 times a week and 8 weeks in total.
Intervention Type
Other
Intervention Name(s)
Virtual reality based games
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper extremities performance with 9 hole peg test
Description
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
Time Frame
Change from Baseline at 8 weeks
Title
Upper extremities performance with Minnesota Manual Dexterity Test
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Cognitive Status with Montreal Cognitive Assessment
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Trunk Functions with Trunk Impairment Scale
Description
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.
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Dynamic balance with functional reach test
Description
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
Time Frame
Change from Baseline at 8 weeks
Title
Balance and mobility with Timed Up and Go Test
Description
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
Time Frame
Change from Baseline at 8 weeks
Title
Quality of life with Parkinson's Disease Questionnaire
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Disease severity and symptoms with Unified Parkinson Disease Rating Scale Part 2 and 3
Description
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.
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gül Yalçın Çakmaklı, Assoc. Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25904081
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.
Results Reference
background
PubMed Identifier
18344392
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.
Results Reference
background
PubMed Identifier
26360239
Citation
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.
Results Reference
background
PubMed Identifier
28528804
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.
Results Reference
background
PubMed Identifier
21306202
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.
Results Reference
background

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

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