Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
Primary Purpose
Parkinson Disease, Balance
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Exer gaming
conventional treatment plan
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Postural instability,, Parkinson Disease,, Exer Game
Eligibility Criteria
Inclusion criteria:
- Diagnosed Parkinson's disease patients in stage I, II,III according to Hoeh n-Yahr classification.
- Patients with balance and gait disorders
Exclusion criteria:
- Other neurological conditions (stroke, Alzheimer)
- Red flag signs (tumors, fractures, infections etc)
- Uncontrolled hypertension.
- Patients with visual disturbances
- Patients with cognitive disorders
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exer gaming treatment plan
conventional treatment plan
Arm Description
Exer gaming treatment plan
conventional treatment plan
Outcomes
Primary Outcome Measures
Unified Parkinson's diseaserating scale (UPDRS)
this test is specifically used in Parkinson patients to check balance
Secondary Outcome Measures
dynamic gait index.
to check dynamic balance
Full Information
NCT ID
NCT05043727
First Posted
August 27, 2021
Last Updated
September 13, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05043727
Brief Title
Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
Official Title
Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2019 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
April 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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
To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients
Detailed Description
Parkinsons Disease is a progressive neuro degenerative disorder manifested by a broad spectrum of motor and non-motor features. Approximately 500 000 people suffer from Parkinson's Disease in the United States and there are approximately 50,000 new cases reported annually . Postural instability, impaired gait, and freezing episodes are all common occurrences in Parkinson's. Agility activities, including supine-to-stand, ambulation, turning, and reaching activities, have been used to reduce freezing episodes, particularly in the early stages of disease.
Conventional physical therapy(balance training, stretching and strengthening exercises) being used for the balance and gait training in Parkinson. In recent time, there has been development in such treatment plan. Virtual reality based games have been used for such purposes. This study will look at the effects of virtual reality gaming in patients suffering from Parkinson's disease and its outcomes in term of gait and balance training. A randomized clinical trial will be performed. total 16 patients will be included in the study and will be divided into two groups. VR Group will be receiving virtual reality based exercise plan while the CONVENTIONAL group will receive conventional physical therapy . Division will be done through lottery method. Unified parkinson's disease rating scale and dynamic gait index will be used to collect the data. Treatment frequency will be three days per week for three months .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Balance
Keywords
Postural instability,, Parkinson Disease,, Exer Game
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
each participant will be requested to draw either number one or two from box. Group number one will receive exer gaming treatment plan Each Patient received twenty four sessions. Each treatment session will of 50 minutes with two minutes rest between each exercise. Group two will receive conventional treatment plan which will include balance training, gait training, stretching and strengthening exercises.Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exer gaming treatment plan
Arm Type
Experimental
Arm Description
Exer gaming treatment plan
Arm Title
conventional treatment plan
Arm Type
Active Comparator
Arm Description
conventional treatment plan
Intervention Type
Combination Product
Intervention Name(s)
Exer gaming
Intervention Description
exer gaming treatment plan will include perfect ten balance, wii skiing, wiicycling. Each Patient will receive twenty four sessions. Each treatment session was of 50 minutes with two minutes rest between each exercise.
Intervention Type
Combination Product
Intervention Name(s)
conventional treatment plan
Intervention Description
it will receive conventional treatment plan which includes balance training, gait training, stretching and strengthening exercises.Each patient will receive twenty four sessions of conventional physical therapy. Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.
Primary Outcome Measure Information:
Title
Unified Parkinson's diseaserating scale (UPDRS)
Description
this test is specifically used in Parkinson patients to check balance
Time Frame
50 minutes
Secondary Outcome Measure Information:
Title
dynamic gait index.
Description
to check dynamic balance
Time Frame
50 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Diagnosed Parkinson's disease patients in stage I, II,III according to Hoeh n-Yahr classification.
Patients with balance and gait disorders
Exclusion criteria:
Other neurological conditions (stroke, Alzheimer)
Red flag signs (tumors, fractures, infections etc)
Uncontrolled hypertension.
Patients with visual disturbances
Patients with cognitive disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeest hashmi, MS NMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25539782
Citation
Liao YY, Yang YR, Cheng SJ, Wu YR, Fuh JL, Wang RY. Virtual Reality-Based Training to Improve Obstacle-Crossing Performance and Dynamic Balance in Patients With Parkinson's Disease. Neurorehabil Neural Repair. 2015 Aug;29(7):658-67. doi: 10.1177/1545968314562111. Epub 2014 Dec 24.
Results Reference
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PubMed Identifier
19025984
Citation
Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
Results Reference
background
PubMed Identifier
7627914
Citation
Lee RG, Tonolli I, Viallet F, Aurenty R, Massion J. Preparatory postural adjustments in parkinsonian patients with postural instability. Can J Neurol Sci. 1995 May;22(2):126-35. doi: 10.1017/s0317167100040208.
Results Reference
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Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
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