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Dual Task and Virtuality Training Innovation to Improve Balance, Posture and Gait in Patients With Parkinson Disease

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ClinicalTrials.gov Identifier: NCT04084743
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

Brief Summary:

Individuals affected with Parkinson disease (PD), are found to be at high risk of motor impairment and non-motor impairment as well. It further leads to affect the quality of life in patients of PD, due to impairments in postural instability, balance impairment and gait disturbances. Hence, various Physiotherapy based rehabilitation is on-demand that improves their quality of life and prognosis. Emerging trends in neuro-rehabilitation are Virtual reality intervention (VRI), that helps the patient to involve in a virtual environment and provide rehabilitation as per need by using different software games. As a result, their balance, posture and gait can improve speedily. In VRI we will be using the latest model of VRI that will include an assessment tool to assess the disability and provide rehabilitation. The cognitive system is also get affected due to physiological changes occur in PD, that leads to impair the other functions during walking such as balance and posture. Because during walking they can not perform dual task orientation to correct their posture and balance. So, dual-task intervention (DTI) is helpful to train them and involve them to participate actively in various activities.

In this project, we will develop an innovative rehabilitation technique to improve the posture, balance and gait in patients with PD. It will include VRI and additive DTI that will keep the patients motivated to perform the exercise actively. To assess the problems we will use standard device posturography that will be used before the intervention and after the intervention to identify the changes in their condition. Additionally, we will use some scales as outcome measures to assess the PD, quality of life and gait. Previous studies show that VR games and dual-task intervention training are an effective method to rehabilitate neurological ill patients. During the experiments, both conventional (DTI) and experimental (VRI+ DTI) will be considered.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Virtual reality intervention Other: Dual task intervention Other: Conventional physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Concurrent Dual Task and Virtual Reality Innovation to Improve Balance, Posture and Gait in Patients With Parkinson Disease
Estimated Study Start Date : June 2, 2022
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual reality training and Dual task intervention
Cognitive and motor Dual-task intervention and virtual reality training intervention in patients with Parkinson's disease
Other: Virtual reality intervention
Virtual reality intervention includes: Maze game software

Other: Dual task intervention
The intervention combined both motor and cognitive training which includes, walking 10 meter (1) Free walking (2) Walking carrying an emptying tray (3) Walking carrying a tray with 4 empty glasses (4) Digit calculations (Counting forward and backward, addition, subtraction, multiplication and division) during walking.

Other: Conventional physiotherapy
  1. Gait training in parallel bar
  2. Balance activities which includes, a. Forward direction activity b. Backward direction activity c. Sideways direction activity

Active Comparator: Conventional physiotherapy and Dual task intervention
The dual-task intervention without virtual reality training intervention in patients with Parkinson's disease
Other: Virtual reality intervention
Virtual reality intervention includes: Maze game software

Other: Dual task intervention
The intervention combined both motor and cognitive training which includes, walking 10 meter (1) Free walking (2) Walking carrying an emptying tray (3) Walking carrying a tray with 4 empty glasses (4) Digit calculations (Counting forward and backward, addition, subtraction, multiplication and division) during walking.

Other: Conventional physiotherapy
  1. Gait training in parallel bar
  2. Balance activities which includes, a. Forward direction activity b. Backward direction activity c. Sideways direction activity




Primary Outcome Measures :
  1. Parkinson's Disease Questionnaire [ Time Frame: change will be measured at baseline and after 4 weeks of intervention ]
    It is a 39 item self report questionnaire, which assess Parkinson disease specific health related quality of the patients. It assess experienced difficulty impact of PD in functioning and well being.

  2. Posturography [ Time Frame: change will be measured at baseline and after 4 weeks of intervention ]
    BIORescue (system for sequential posture analysis and rehabilitation- made in France) allows carrying out a comparative assessment supported by many analyses repeated at different times throughout the treatment. Several types of exercises make it possible to work on the reestablishment of the transfer of the support, the stability, the balance, the anticipation of movement, etc.


Secondary Outcome Measures :
  1. UPDRS [ Time Frame: change will be measured at baseline and after 4 weeks of intervention ]
    The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's Disease in patients. The UPDRS scale consist of te following five segments: (1) Mentation, Behaviour, and Mood, (2) ADL ,(3) Motor section,(4) Modified Hoehn and Yahr scale, (5)Schwab and England ADL scale. Each answer to the scale is evaluated by a medical professional that specializes in Parkinson's disease during patient interviews. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic PD (according to the united kingdom parkinson's disease society brain bank criteria)
  • Hoehn and Yahr stage III
  • Able to walk without any assistance
  • Age between 45-70
  • Both sex male and female

Exclusion Criteria:

  • Any neurological disease other than PD
  • Vestibular disorders
  • Musculoskeletal impairments that could affect gait
  • Inability to stand and walk unassisted
  • Uncooperative patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084743


Contacts
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Contact: Asir J Samuel, MPT, (Ph.D) 8059930222 asirjohnsamuel@mmumullana.org

Sponsors and Collaborators
Asir John Samuel
Investigators
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Principal Investigator: Adarsh K Srivastav, MPT Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Additional Information:
Publications of Results:
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Responsible Party: Asir John Samuel, Associate Professor, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT04084743    
Other Study ID Numbers: MMDU/2019/01
U1111-1234-9952 ( Other Identifier: UTN by WHO International Critical Trial Registry Platform )
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University (Deemed to be University):
Virtual reality
Targeted therapy
Computer game
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases