NCT04084743

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
2.7 years until next milestone

Study Start

First participant enrolled

June 2, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

August 31, 2019

Last Update Submit

September 30, 2021

Conditions

Keywords

Virtual realityTargeted therapyComputer game

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (1)

  • UPDRS

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

Study Arms (2)

Virtual reality training and Dual task intervention

EXPERIMENTAL

Cognitive and motor Dual-task intervention and virtual reality training intervention in patients with Parkinson's disease

Other: Virtual reality interventionOther: Dual task interventionOther: Conventional physiotherapy

Conventional physiotherapy and Dual task intervention

ACTIVE COMPARATOR

The dual-task intervention without virtual reality training intervention in patients with Parkinson's disease

Other: Virtual reality interventionOther: Dual task interventionOther: Conventional physiotherapy

Interventions

Virtual reality intervention includes: Maze game software

Conventional physiotherapy and Dual task interventionVirtual reality training and 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.

Conventional physiotherapy and Dual task interventionVirtual reality training and Dual task intervention

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

Conventional physiotherapy and Dual task interventionVirtual reality training and Dual task intervention

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Adarsh K Srivastav, MPT

    Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asir J Samuel, MPT, (Ph.D)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 10, 2019

Study Start

June 2, 2022

Primary Completion

October 31, 2023

Study Completion

December 30, 2023

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share