Knee OsteoarthristisNCT05777421
Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis
A study testing Conventional Physical Therapy for Knee Osteoarthriths and Virtual Reality-Based Therapeutic Exercise regimes in people with Knee Osteoarthristis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Conventional Physical Therapy for Knee Osteoarthriths and Virtual Reality-Based Therapeutic Exercise regimes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral knee OA involving mediolateral compartment
- Knee OA grade 2
- Aged 40-65 years
- Both Male and Female
- NPRS value greater than
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
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.
- Conditions
- Knee Osteoarthristis
- Being tested
- Conventional Physical Therapy for Knee Osteoarthriths, Virtual Reality-Based Therapeutic Exercise regimes
- Keywords
- Range of Motion, Proprioception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical Therapy for Knee OsteoarthrithsProcedure or surgery
Participants of Group A will receive the conventional physical therapy for Knee Osteoarthistis for a duration of 6 weeks atleast 2 times a week
Virtual Reality-Based Therapeutic Exercise regimesProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Virtual Reality-Based Therapeutic Exercise regimes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia
Measured: 6 weeks
Pain intensity
Will be Measured using the Numeric Pain rating scale
Measured: 6 weeks
Functional Disability
Will be measured using WOMAC Osteoarthritis Index
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Jan 2023
- Primary completion15 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777421
- Sponsor's protocol ID
- FUI/CTR/2023/5
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05777421
- Acronym / sponsor ID
- FUI/CTR/2023/5
- Conditions
- Knee Osteoarthristis
- Keywords
- Range of Motion, Proprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy Regime for Knee Osteoarthrithis | Active comparator | Procedure: Conventional Physical Therapy for Knee OsteoarthrithsPt 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. |
| Virtual reality Based Therapeutic Exercise Regimes | Experimental | Procedure: Virtual Reality-Based Therapeutic Exercise regimesVR-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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with unilateral knee OA involving mediolateral compartment
- Knee OA grade 2
- Aged 40-65 years
- Both Male and Female
- NPRS value greater than
Key exclusion criteria (8 listed)
- Patients with history of
- History of systemic disorder (e.g., rheumatoid arthritis, ankylosing spondylitis).
- History of malignancy.
- History of trauma.
- Previous knee surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Physical Therapy for Knee OsteoarthrithsParticipants of Group A will receive the conventional physical therapy for Knee Osteoarthistis for a duration of 6 weeks atleast 2 times a week | Procedure or surgery | Conventional Physical Therapy Regime for Knee Osteoarthrithis |
| Virtual Reality-Based Therapeutic Exercise regimes* 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. | Procedure or surgery | Virtual reality Based Therapeutic Exercise Regimes |
Primary outcome
Kinesiophobia
Time frame: 6 weeks
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia
Pain intensity
Time frame: 6 weeks
Will be Measured using the Numeric Pain rating scale
Functional Disability
Time frame: 6 weeks
Will be measured using WOMAC Osteoarthritis Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy for Knee Osteoarthriths and Virtual Reality-Based Therapeutic Exercise regimes in people with Knee Osteoarthristis, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.