EFFECTS OF VIRTUAL REALITY WITH MOTOR IMAGERY TECHNIQUES IN ADDITION TO ROUTINE PHYSICAL THERAPY IN PATIENTS WITH PARKINSON’S DISEASE: A RANDOMIZED CONTROLLED TRIAL
1. To compare the effects of virtual reality with motor imagery techniques in addition to routine physical therapy on balance in patients with Parkinson’s disease
2. To compare the effects of virtual reality with motor imagery techniques in addition to routine physical therapy on motor function in patients with Parkinson’s disease
3. To compare the effects of virtual reality with motor imagery techniques in addition to routine physical therapy on activities of daily living in patients with Parkinson’s disease
Design
parallel group, single blind, randomized controlled trial
Settings and conduct
Department of Physical Therapy, Safi Hospital, Faisalabad, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Idiopathic Parkinson’s disease
Modified Hoehn and Yahr (H&Y) Stage-1 to Stage-3
Between the ages of 50 and 80 years of both gender
Independent in transfers
Score equal to or greater than 24 score on the Mini-Mental State Examination (MMSE)(62).
Previous lack of participation in balance or motor training
Exclusion Criteria: The following exclusion criteria will be applied:
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’s or “on-off” phases
Previous history of surgery for PD.
History of Virtual games used in past 3 months
Virtual game phobia
Intervention groups
Intervention Group– will get Routine Physical Therapy + Virtual Reality + Motor Imagery
60 minutes of session, Alternative three days/ week for 12 weeks.
Main outcome variables
Motor Function, Balance and Activities of Daily Living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200221046567N1
Registration date:2020-04-01, 1399/01/13
Registration timing:prospective
Last update:2020-04-01, 1399/01/13
Update count:0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Muhammad Kashif
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 41 8777210
Email address
kashif.shaffi@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2641-07-06, 2020/04/15
Expected recruitment end date
2642-01-05, 2020/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF VIRTUAL REALITY WITH MOTOR IMAGERY TECHNIQUES IN ADDITION TO ROUTINE PHYSICAL THERAPY IN PATIENTS WITH PARKINSON’S DISEASE: A RANDOMIZED CONTROLLED TRIAL
Public title
EFFECTS OF VIRTUAL REALITY WITH MOTOR IMAGERY TECHNIQUES IN ADDITION TO ROUTINE PHYSICAL THERAPY IN PATIENTS WITH PARKINSON’S DISEASE: A RANDOMIZED CONTROLLED TRIAL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Idiopathic Parkinson’s disease Modified Hoehn and Yahr (H&Y) Stage-1 to Stage-3 Between the ages of 50 and 80 years of both gender Independent in transfers Score equal to or greater than 24 score on the Mini-Mental State Examination (MMSE) 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’s or “on-off” phases Previous history of surgery for PD. History of Virtual games used in past 3 months Virtual game phobia
Age
From 50 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
The study would be single-blinded as assessors of the study would be kept blind of the treatment group to which the patient will be allocated.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of University Institute of Physical Therapy, The University of Lahore
Street address
1 KM Raiwind Road
City
Lahore
Postal code
54792
Approval date
2641-04-11, 2020/01/22
Ethics committee reference number
IRB-UOL-FAHS/694/2020
Health conditions studied
1
Description of health condition studied
PARKINSON’S DISEASE
ICD-10 code
G20
ICD-10 code description
Parkinson's disease, virtual reality, motor imagery, balance, motor function, activities of daily living
Primary outcomes
1
Description
Balance
Timepoint
before intervention and 6, 12 week and after one month of intervention
Method of measurement
Berg Balance Scale and Activities specific Balance Confidence Scale
2
Description
Motor Function
Timepoint
before intervention and 6, 12 week and after one month of intervention