Knee OsteoarthritisNCT05258227
Comapre Effects Of Proprioceptive Training And Core Instability Strength Training In Knee Osteoarthritis Patients
A study testing Conservational Physical Therapy and Proprioceptive Strength Training and Conservational Physical Therapy and Core Instability Strength Training in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to determine the influence of core instability exercises in comparison to proprioceptive training in relieving pain, improving balance and physical function in general population of knee Osteoarthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Conservational Physical Therapy and Proprioceptive Strength Training and Conservational Physical Therapy and Core Instability Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 28 Mar 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Knee Osteoarthritis disease
- Kellgren Lawrence stage 1 to stage 4
- Unilateral or Bilateral Knee Osteoarthritis
- Patient who are willing to participate
Who cannot join
- History of any neurological condition e.g. Parkinson or vertigo.
- History of any past surgical procedure related to lower extremity.
- History of any chronic disease (hepatic, cardiac or renal diseases) which can affect the exercise training.
- History of severe orthopedic issues like fractures which may interfere in treatment sessions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: A Randomized Control Trial To Comapre The Effects Of Proprioceptive Training And Core Instability Strength Training On Balance,Pain And Physical Functions In Patients With Knee Osteoarthritis
This study aims to determine the influence of core instability exercises in comparison to proprioceptive training in relieving pain, improving balance and physical function in general population of knee Osteoarthritis. The objective is to achieve beneficial results of interventions which can be used in betterment of treatment plan.
Read the detailed description
A randomized control trial will be held at Safi hospital Faisalabad after the approval of the synopsis. The study will be double blinded clinical trial. Simple lottery method will be practiced to allocate subjects into two groups. Subjects are selected according to there explained inclusion exclusion criteria. The two groups are differentiated as control group and experimental group. Both the groups will be given the baseline intervention including TENS and Infrared. Along with baseline treatment control group will be given proprioceptive training and experimental group will be given core instability exercises. The evaluation is done before the research begin, after 6 weeks, after 12th week and Follow up on 16th week at the end of therapy. The outcomes will be assessed through Visual Analog Scale, Western Ontario and McMaster Universities Arthritis Index and Fullerton Advanced Balance scale. The data will be recorded pre and post treatment and compared after 12th week. Informed consent should be signed by each patient and analysis is done by Statistical Package of Social Sciences Version 21.
- Conditions
- Knee Osteoarthritis
- Being tested
- Conservational Physical Therapy and Proprioceptive Strength Training, Conservational Physical Therapy and Core Instability Strength Training
- Keywords
- Proprioceptive Training, Core Instability, Strength Training, Knee Osteoarthritis, Randomized Control Trial, Balance, Physical Functions
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservational Physical Therapy and Proprioceptive Strength TrainingOther
The proprioceptive training cycle consist of squats, single leg stand, slide steps , forward and backward step, toe walking , heel walking , side sway etc.
Conservational Physical Therapy and Core Instability Strength TrainingOther
Core stability is essential part of lower limb rehabilitation; it is also known protocol which includes group of exercises in both standing and sitting improving biomechanics and functional performance of the body.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Strength Training | Experimental | * Conservation physical therapy includes TENS 15 min + Infrared 15 min simultaneously.
* Proprioceptive strength training for 30 min includes following exercises:
Strengthening of Quadriceps Ankle extensors and Hip abductors strengthening Zigzag walking Heel to toe walk forward and backwards toe to heel Standing on one leg while holding wall, eyes open and eyes closed Receives: Other: Conservational Physical Therapy and Proprioceptive Strength Training |
| Core Instability Strength Training | Experimental | * Conservational therapy includes TENS for 15 min+ Infrared for 15 min simultaneously.
* Core instability strength training for 30 minutes includes following exercises:
Quadriceps stretch, crook lying, abdominal hallowing Dynamic Hamstrings stretch Bridging arms at side Crook lying+lifting both legs at right angle with hands resting on thighs Receives: Other: Conservational Physical Therapy and Core Instability Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kellgren Lawrence scale
Kellgren-Lawrence classification is typically applied within the context of knee Osteoarthritis. Based on the radiographic features, the severity of Osteoarthritis is given a grade from 0 to 4, with grade 0 signifying no presence of Osteoarthritis and grade 4 signifying severe Osteoarthritis.
Measured: 12th Week
Visual Analogue Scale
Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
Measured: 12th Week
Fullerton Advanced Balance Scale
The Fullerton Advanced Balance Scale assesses both static and dynamic balance under varying sensory conditions. Balance is measured in this test in active older adults who have higher levels of function.
Measured: 12th Week
Western Ontario and Mc Master Universities osteoarthritis Scale
The Western Ontario and McMaster Universities osteoarthritis scale is widely used to assess pain, stiffness, and function in patients with osteoarthritis of the hip or knee.
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Mar 2021
- Primary completion25 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258227
- Sponsor's protocol ID
- REC-FSD-00278
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial To Comapre The Effects Of Proprioceptive Training And Core Instability Strength Training On Balance,Pain And Physical Functions In Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05258227
- Acronym / sponsor ID
- REC-FSD-00278
- Conditions
- Knee Osteoarthritis
- Keywords
- Proprioceptive Training, Core Instability, Strength Training, Knee Osteoarthritis, Randomized Control Trial, Balance, Physical Functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 28 Feb 2022 (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.
This study aims to determine the influence of core instability exercises in comparison to proprioceptive training in relieving pain, improving balance and physical function in general population of knee Osteoarthritis. The objective is to achieve beneficial results of interventions which can be used in betterment of treatment plan.
Detailed description
A randomized control trial will be held at Safi hospital Faisalabad after the approval of the synopsis. The study will be double blinded clinical trial. Simple lottery method will be practiced to allocate subjects into two groups. Subjects are selected according to there explained inclusion exclusion criteria. The two groups are differentiated as control group and experimental group. Both the groups will be given the baseline intervention including TENS and Infrared. Along with baseline treatment control group will be given proprioceptive training and experimental group will be given core instability exercises. The evaluation is done before the research begin, after 6 weeks, after 12th week and Follow up on 16th week at the end of therapy. The outcomes will be assessed through Visual Analog Scale, Western Ontario and McMaster Universities Arthritis Index and Fullerton Advanced Balance scale. The data will be recorded pre and post treatment and compared after 12th week. Informed consent should be signed by each patient and analysis is done by Statistical Package of Social Sciences Version 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Strength Training | Experimental | Other: Conservational Physical Therapy and Proprioceptive Strength Training* Conservation physical therapy includes TENS 15 min + Infrared 15 min simultaneously. * Proprioceptive strength training for 30 min includes following exercises: Strengthening of Quadriceps Ankle extensors and Hip abductors strengthening Zigzag walking Heel to toe walk forward and backwards toe to heel Standing on one leg while holding wall, eyes open and eyes closed |
| Core Instability Strength Training | Experimental | Other: Conservational Physical Therapy and Core Instability Strength Training* Conservational therapy includes TENS for 15 min+ Infrared for 15 min simultaneously. * Core instability strength training for 30 minutes includes following exercises: Quadriceps stretch, crook lying, abdominal hallowing Dynamic Hamstrings stretch Bridging arms at side Crook lying+lifting both legs at right angle with hands resting on thighs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Knee Osteoarthritis disease
- Kellgren Lawrence stage 1 to stage 4
- Unilateral or Bilateral Knee Osteoarthritis
- Patient who are willing to participate
Key exclusion criteria (4 listed)
- History of any neurological condition e.g. Parkinson or vertigo.
- History of any past surgical procedure related to lower extremity.
- History of any chronic disease (hepatic, cardiac or renal diseases) which can affect the exercise training.
- History of severe orthopedic issues like fractures which may interfere in treatment sessions.
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 |
|---|---|---|
| Conservational Physical Therapy and Proprioceptive Strength TrainingThe proprioceptive training cycle consist of squats, single leg stand, slide steps , forward and backward step, toe walking , heel walking , side sway etc. | Other | Proprioceptive Strength Training |
| Conservational Physical Therapy and Core Instability Strength TrainingCore stability is essential part of lower limb rehabilitation; it is also known protocol which includes group of exercises in both standing and sitting improving biomechanics and functional performance of the body. | Other | Core Instability Strength Training |
Primary outcome
Kellgren Lawrence scale
Time frame: 12th Week
Kellgren-Lawrence classification is typically applied within the context of knee Osteoarthritis. Based on the radiographic features, the severity of Osteoarthritis is given a grade from 0 to 4, with grade 0 signifying no presence of Osteoarthritis and grade 4 signifying severe Osteoarthritis.
Visual Analogue Scale
Time frame: 12th Week
Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
Fullerton Advanced Balance Scale
Time frame: 12th Week
The Fullerton Advanced Balance Scale assesses both static and dynamic balance under varying sensory conditions. Balance is measured in this test in active older adults who have higher levels of function.
Western Ontario and Mc Master Universities osteoarthritis Scale
Time frame: 12th Week
The Western Ontario and McMaster Universities osteoarthritis scale is widely used to assess pain, stiffness, and function in patients with osteoarthritis of the hip or knee.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservational Physical Therapy and Proprioceptive Strength Training and Conservational Physical Therapy and Core Instability Strength Training in people with Knee Osteoarthritis, run by Riphah International University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Kellgren Lawrence scale (time frame: 12th Week). The study lists 4 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 28 Apr 2022.