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

• ClinicalTrials.gov Identifier: NCT04884646
• Recruitment Status: Completed
• First Posted: May 13, 2021
• Last Update Posted: June 16, 2021
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Other: VR with Routine physical therapy and Virtual reality; Other: Motor Imagery with Routine physical therapy; Other: Routine physical therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The study would be single blinded as accessor of the study would be kept blind of the treatment group to which patient would be allocated.After the complete initial screening process, every recruited patient will be accessed by an independent assessor, expert will use outcome measuring tools. his will be recorded as baseline measurement assessment
• Primary Purpose: Treatment
• Official Title: Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease: A Randomised Controlled Trial
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: June 12, 2021
• Actual Study Completion Date: June 12, 2021

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: 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 Name: Rehabilitation following Routine physical therapy treatment

Outcome Measures

Primary Outcome Measures :

1. 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 .
2. 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. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Pakistan

Ripah International University

Faisalabad, Punjab, Pakistan, 3800

Sponsors and Collaborators

Riphah International University

Investigators

• Study Chair: Muhammad Kashif; Riphah International University

More Information

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT04884646
• Other Study ID Numbers: REC/Fsd/0115
• First Posted: May 13, 2021
• Last Update Posted: June 16, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• 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:

Parkinson; Virtual Reality; Motor Imagery; Routine Physical Therapy

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases