search
Back to results

Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthristis

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Physical Therapy for Knee Osteoarthriths
Virtual Reality-Based Therapeutic Exercise regimes
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthristis focused on measuring Range of Motion, Proprioception

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with unilateral knee OA involving mediolateral compartment Knee OA grade 2 Aged 40-65 years Both Male and Female NPRS value greater than Exclusion Criteria: Patients with history of History of systemic disorder (e.g., rheumatoid arthritis, ankylosing spondylitis). History of malignancy. History of trauma. Previous knee surgery. Congenital musculoskeletal deformity (e.g., scoliosis, kyphosis). Patients with history of fracture Patients with history of Chondropatella Malacia

Sites / Locations

  • Foundation University College of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physical Therapy Regime for Knee Osteoarthrithis

Virtual reality Based Therapeutic Exercise Regimes

Arm Description

Pt will receive conventional therapy targeting stretching and stretching of knee musculature in combination with electrotherapy for pain modulation. Frequency : 2-3 times for a duration of 6 weeks Pt will be guided home plan based exercises.

VR-based therapeutic exercise regimes utilizing Xbox, that focus on different activities like Partial squatting, lunges, side lunge, calf raises, and hamstring curls. Gaming exercises begin will an easy warm up round and get challenging with different rounds of each game as the patient progresses to week 6. Frequency: 2-3 times for a duration for 6 weeks Pt will be guided home plan based exercises

Outcomes

Primary Outcome Measures

Kinesiophobia
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia
Pain intensity
Will be Measured using the Numeric Pain rating scale
Functional Disability
Will be measured using WOMAC Osteoarthritis Index

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
March 20, 2023
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT05777421
Brief Title
Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis
Official Title
Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

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

5. Study Description

Brief Summary
Knee Osteoarthritis is one of the most prevalent degenerative conditions in Pakistan. Although a variety of Physical therapy treatments have been proven to be beneficial in patients with early stages of knee Osteoarthritis. However, a few secondary impairments like Kinesiophobia which is the fear of movement have been unaddressed. Usually after conventional physical therapy, patients find immediate or short-term relief and that leads to cessation of follow up sessions. In situations like these, kinesiophobia is the greatest threat to mobility and can eventually effect quality of life by decreasing functional disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthristis
Keywords
Range of Motion, Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Natural apophyseal glides and the second will receive Natural Apophyseal Glides in addition to cranial base release with conventional physical therapy. Both groups will be recruited concurrently.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physical Therapy Regime for Knee Osteoarthrithis
Arm Type
Active Comparator
Arm Description
Pt will receive conventional therapy targeting stretching and stretching of knee musculature in combination with electrotherapy for pain modulation. Frequency : 2-3 times for a duration of 6 weeks Pt will be guided home plan based exercises.
Arm Title
Virtual reality Based Therapeutic Exercise Regimes
Arm Type
Experimental
Arm Description
VR-based therapeutic exercise regimes utilizing Xbox, that focus on different activities like Partial squatting, lunges, side lunge, calf raises, and hamstring curls. Gaming exercises begin will an easy warm up round and get challenging with different rounds of each game as the patient progresses to week 6. Frequency: 2-3 times for a duration for 6 weeks Pt will be guided home plan based exercises
Intervention Type
Procedure
Intervention Name(s)
Conventional Physical Therapy for Knee Osteoarthriths
Intervention Description
Participants of Group A will receive the conventional physical therapy for Knee Osteoarthistis for a duration of 6 weeks atleast 2 times a week
Intervention Type
Procedure
Intervention Name(s)
Virtual Reality-Based Therapeutic Exercise regimes
Intervention Description
Participants of Group B will receive Virtual Reality Based therapeutic exercises on the Xbox. The difficulty level of the games will progess each week. The duration of training will also also progress at treatment week progresses. Frequency: 2-3 times a week for 6 weeks. Minimum 12 sessions in total.
Primary Outcome Measure Information:
Title
Kinesiophobia
Description
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia
Time Frame
6 weeks
Title
Pain intensity
Description
Will be Measured using the Numeric Pain rating scale
Time Frame
6 weeks
Title
Functional Disability
Description
Will be measured using WOMAC Osteoarthritis Index
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unilateral knee OA involving mediolateral compartment Knee OA grade 2 Aged 40-65 years Both Male and Female NPRS value greater than Exclusion Criteria: Patients with history of History of systemic disorder (e.g., rheumatoid arthritis, ankylosing spondylitis). History of malignancy. History of trauma. Previous knee surgery. Congenital musculoskeletal deformity (e.g., scoliosis, kyphosis). Patients with history of fracture Patients with history of Chondropatella Malacia
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis

We'll reach out to this number within 24 hrs