Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease.

June 14, 2021 updated by: Riphah International University

Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease: A Randomised Controlled Trial

The aim of this study is to investigate the effects of VR and MI techniques in addition to routine physical therapy on motor skills, balance and ADL in patients with Parkinson's disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Parkinson's disease is one of the most common, insidious neurological disorders with major motor symptoms, including bradykinesia, resting tremors, rigidity, and postural disorders. Virtual reality and motor imagery are among the more innovative techniques for rehabilitation of patients with Parkinson's disease that promote motor learning through both explicit and implicit processes.This study is unique in that it examines the effects of VR versus MI on motor skills, balance, and daily living activities in individuals with Parkinson's disease

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 3800
        • ripah international university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Idiopathic Parkinson's disease
  • Modified Hoehn and Yahr Scale(H&Y stages I to III)
  • Between the ages of 50 and 80 years of both genders
  • Independent in transfers
  • A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
  • Previous lack of participation in balance or motor training.

Exclusion Criteria:

  • History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
  • History of orthopedic issues such as pain, fracture, or lower limb pathology,
  • History of visual abnormalities,
  • History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
  • The participants having severe dyskinesia or "on-off" phases,
  • Previous history of surgery for PD,
  • History of virtual games used for treatment in the past three months, and
  • Virtual game phobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Virtual Reality with Routine Physical Therapy
The duration of the VR will be from 10 to 15 minutes during each session and Routine Physical Therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training)
Other: VR with Routine physical therapy and Virtual reality
VR group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks
Other Names:
  • Rehabilitation following VR with Routine physical therapy treatment
EXPERIMENTAL: Motor imagery technique with Routine Physical Therapy
Motor Imagery techniques will be given for 5 to 10 minutes along with routine physical therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training)
Other: Motor Imagery with Routine physical therapy
MI group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks
Other Names:
  • Rehabilitation following MI with Routine physical therapy treatment
EXPERIMENTAL: Routine Physical Therapy
Only routine physical therapy will be given (including warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training)
Other: Routine physical therapy
Group A will be given routine physical therapy in 40-min sessions and 20 min of walking and cycling with a short period of rest, every alternate day (3 days per week) for 12 weeks
Other Names:
  • Rehabilitation following Routine physical therapy treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Unified Parkinson's disease Rating Scale Part II
Time Frame: 3 months
This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales: Sub-scale II comprises the evaluation of activities in daily living. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability .
3 months
Unified Parkinson's disease Rating Scale Part III
Time Frame: 3 months
This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales and sub-scale III evaluates the motor system. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability
3 months
Berg Balance Scale (BBS)
Time Frame: 3 months
The scale has been established as the most widely used assessment tool in clinical settings to identify changes in balance performance. A score of less than 45 is considered a limit for the risk of falling, while a score of 56 relates to functional balance
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Activities-specific Balance Confidence Scale (ABC):
Time Frame: 3 months
This scale is used as a predictor of falls in patients with neurological deficits. Patients are rated from 0% to 100%, with 0% interpreted as not at all safe and 100% as completely safe
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/Fsd/0115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings