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Status unknownNCT04084743Updated Oct 1, 2021

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

An interventional study of Virtual reality intervention and Dual task intervention in Parkinson Disease, sponsored by Asir John Samuel. Status unknown. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-10-01.

Sponsored by Asir John Samuel · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
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Study 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.

Read the detailed description

Introduction Parkinson disease (PD) is a neurodegenerative disease of the brain, leads to degeneration and causing the motor and non-motor symptoms. PD is characterized by dopaminergic neurotransmitter deficiency. It is a progressive neurological condition that affects more than 10 million people worldwide. Cardinal features of PD are bradykinesia, rigidity and tremor are common symptoms. But gait, postural instability and balance are common risk factors for falling in these population and have a great impact on the quality of life.

There are various treatments available in the pharmacological and surgical field. However, their effectiveness is not satisfying much and invasive procedures are not cost-effective. With the progression of disease patent often become less responsive to medication and develop various difficulties in their daily activities.

Therefore, Physiotherapy(PT) interventions are very important to rehabilitate the patients affected with PD. It helps to improve movement function, motor performance and increase the quality of life. There is active participation from the side of the patient will be there that keeps the patients motivated.

Among emerging approaches in the field of PT, virtual reality(VR) has been proposed as an innovative and effective method for improving gait, balance and postural instability. Patients of PD faces cognitive impairment which leads to impaired attention during their gait because they are unable to put attention on their posture and balance. So attention is responsible for maintaining posture and gait, leads to reduce dual-task ability which is very important in our daily life activities. So to improve the quality of life by correcting posture and gait cognitive dual-task intervention training plays important role in rehabilitation.

Various studies suggested single intervention to improve gait, posture and balance ability in PD patients. To our knowledge, no study investigated the possibility to apply VR with dual-task intervention. the current study compares the effects of VR intervention (VRI) and cognitive dual-task intervention(DTI) between posture, balance and gait. To our knowledge, this will be the first study to compare VRI and DTI on a variety of motor tasks in the homogenous group in their OFF period of medication state.

We hypothesized that addition of VRI with DTI can lead to improve the balance, postural instability and gait in patients with PD and can slow the progression of the disease without changing the medication plan.

  1. Materials and Methods: Ethical statement and subject recruitment The study protocol was approved by the institutional research advisory committee (RAC) and registered under the Universal Trial Number (UTN). The protocol will be registered under ClinicalTrials.gov, under World Health Organization International Clinical Trials Registry Platform and then the study will be submitted for the ethical approval by the institutional ethics committee of Maharishi Markandeshwar Deemed to Be University, Mullana, Haryana with a unique reference number. The study will be executed in accordance with the principles of the Declaration of Helsinki (Revised, 2013) and National ethical guidelines for Biomedical and Health research involving human participants by Indian council for medical research (ICMR, 2017). The purpose of the study will be clearly explained to the patient with Parkinson disease. A written informed consent form will be obtained from the recruited patients.

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 between45-70 Both sex male and female Exclusion criteria Any neurological disease other than PD Vestibular disorders Urinary incontinence Musculoskeletal impairments that could affect gait Inability to stand and walk unassisted Uncooperative patients Random Allocation Total of X patient with Parkinson disease was screened and through convenience sampling method, n patients were selected based on the inclusion criteria for the double, blind three-group pretest-posttest randomized controlled design. Demographic data will be recorded for all the patients. The patient with PD will be allocated in three groups, dual-task treatment group (DTG), virtual reality treatment group (VRG) and daily physiotherapy group (DPG) by compute generated block randomization technique. According to it, there will be n blocks, with the matrix design of n × N, where n being rowed. Each row could have n blocks, patients will be allotted to one of the three groups based on the randomly generated number by computer. Once all the first row will be allotted, then the next row block will be opened for enrolment. The advantage of this method of randomization is that the number of patients assigned to each group over time would have been approximately equal. By this, the unequal allocation of sample size will be avoided. The outcome assessor and the participants involved in the intervention will be blinded.

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Conditions studied

  • Parkinson Disease

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Keywords

  • Virtual reality
  • Targeted therapy
  • Computer game
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 64 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Asir John Samuel is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • 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 · Other: Dual task intervention · Other: Conventional physiotherapy

  • 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 · Other: Dual task intervention · Other: Conventional physiotherapy

Interventions

  • OtherVirtual reality intervention

    Virtual reality intervention includes: Maze game software

  • OtherDual 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.

  • OtherConventional physiotherapy

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

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What researchers measure

Primary outcomes

  1. Parkinson's Disease Questionnaire

    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.

    Time frame: change will be measured at baseline and after 4 weeks of intervention

  2. Posturography

    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.

    Time frame: change will be measured at baseline and after 4 weeks of intervention

Secondary outcomes

  1. UPDRS

    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).

    Time frame: change will be measured at baseline and after 4 weeks of intervention

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hubbard B, Pothier D, Hughes C, Rutka J. A portable, low-cost system for posturography: a platform for longitudinal balance telemetry. J Otolaryngol Head Neck Surg. 2012 Apr;41 Suppl 1:S31-5. PubMed 22569047 ↗
  • Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013 Feb;19(2):218-21. doi: 10.1016/j.parkreldis.2012.10.008. Epub 2012 Oct 25. PubMed 23102808 ↗
  • Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17. PubMed 22463132 ↗
  • Bisson E, Contant B, Sveistrup H, Lajoie Y. Functional balance and dual-task reaction times in older adults are improved by virtual reality and biofeedback training. Cyberpsychol Behav. 2007 Feb;10(1):16-23. doi: 10.1089/cpb.2006.9997. PubMed 17305444 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04084743
Lead sponsor
Asir John Samuel
Responsible party
Asir John Samuel (Associate Professor, Maharishi Markendeswar University (Deemed to be University)) — Sponsor-investigator
First posted
Sep 10, 2019
Start date
Jun 2, 2022 (estimated)
Primary completion
Oct 31, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Oct 1, 2021

Study contacts

Asir J Samuel, MPT, (Ph.D)
Contact
asirjohnsamuel@mmumullana.org
8059930222
Adarsh K Srivastav, MPT
principal investigator · Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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