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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
VR with Routine physical therapy and Virtual reality
Motor Imagery with Routine physical therapy
Routine physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson, Virtual Reality, Motor Imagery, Routine Physical Therapy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ripah International University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Virtual Reality with Routine Physical Therapy

Motor imagery technique with Routine Physical Therapy

Routine Physical Therapy

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Unified Parkinson's disease Rating Scale Part II
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 .
Unified Parkinson's disease Rating Scale Part III
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
Berg Balance Scale (BBS)
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

Activities-specific Balance Confidence Scale (ABC):
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

Full Information

First Posted
May 7, 2021
Last Updated
June 14, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04884646
Brief Title
Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease.
Official Title
Effects of Virtual Reality Versus Motor Imagery Versus Routine Physical Therapy in Patients With Parkinson's Disease: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 12, 2021 (Actual)
Study Completion Date
June 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson, Virtual Reality, Motor Imagery, Routine Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality with Routine Physical Therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Motor imagery technique with Routine Physical Therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Routine Physical Therapy
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
VR with Routine physical therapy and Virtual reality
Other Intervention Name(s)
Rehabilitation following VR with Routine physical therapy treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Motor Imagery with Routine physical therapy
Other Intervention Name(s)
Rehabilitation following MI with Routine physical therapy treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Routine physical therapy
Other Intervention Name(s)
Rehabilitation following Routine physical therapy treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Unified Parkinson's disease Rating Scale Part II
Description
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 .
Time Frame
3 months
Title
Unified Parkinson's disease Rating Scale Part III
Description
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
Time Frame
3 months
Title
Berg Balance Scale (BBS)
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Activities-specific Balance Confidence Scale (ABC):
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Ripah International University
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
3800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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