NCT05777421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 9, 2023

Last Update Submit

March 20, 2023

Conditions

Keywords

Range of Motion, Proprioception

Outcome Measures

Primary Outcomes (3)

  • Kinesiophobia

    Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia

    6 weeks

  • Pain intensity

    Will be Measured using the Numeric Pain rating scale

    6 weeks

  • Functional Disability

    Will be measured using WOMAC Osteoarthritis Index

    6 weeks

Study Arms (2)

Conventional Physical Therapy Regime for Knee Osteoarthrithis

ACTIVE COMPARATOR

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.

Procedure: Conventional Physical Therapy for Knee Osteoarthriths

Virtual reality Based Therapeutic Exercise Regimes

EXPERIMENTAL

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

Procedure: Virtual Reality-Based Therapeutic Exercise regimes

Interventions

Participants of Group A will receive the conventional physical therapy for Knee Osteoarthistis for a duration of 6 weeks atleast 2 times a week

Conventional Physical Therapy Regime for Knee Osteoarthrithis

* 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.

Virtual reality Based Therapeutic Exercise Regimes

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with unilateral knee OA involving mediolateral compartment
  • Knee OA grade 2
  • Aged 40-65 years
  • Both Male and Female
  • NPRS value greater than

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations