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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04884646
Other study ID # REC/Fsd/0115
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date June 12, 2021

Study information

Verified date June 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 12, 2021
Est. primary completion date June 12, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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
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

Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . 3 months
Primary 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 3 months
Primary 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 3 months
Secondary 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 3 months
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