Effects of Exer Gaming on Balance and Gait in Parkinson's Patients

• Sponsor: Riphah International University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05043727
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Balance	Combination Product: Exer gaming; Combination Product: conventional treatment plan	N/A

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 .

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Exer Gaming on Balance and Gait in Parkinson's Patients
• Actual Study Start Date: Oct 6, 2019
• Actual Primary Completion Date: Apr 6, 2020
• Actual Study Completion Date: Apr 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exer gaming treatment plan Exer gaming treatment plan	Combination Product: Exer gaming; 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.
Active Comparator: conventional treatment plan conventional treatment plan	Combination Product: conventional treatment plan; 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.

Outcome Measures

Primary Outcome Measures

1. Unified Parkinson's diseaserating scale (UPDRS) [50 minutes]

   this test is specifically used in Parkinson patients to check balance

Secondary Outcome Measures

1. dynamic gait index. [50 minutes]

   to check dynamic balance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riphah International University	Islamabad	Fedral	Pakistan	44000

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: zeest hashmi, MS NMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05043727
• Other Study ID Numbers: REC/Lhr/2024 Shahbaz
• First Posted: Sep 14, 2021
• Last Update Posted: Sep 14, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: Postural instability,; Parkinson Disease,; Exer Game
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Sep 14, 2021