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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258227
Other study ID # REC-FSD-00278
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date March 28, 2022

Study information

Verified date April 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The objective is to achieve beneficial results of interventions which can be used in betterment of treatment plan.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 28, 2022
Est. primary completion date March 25, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Knee Osteoarthritis disease - Kellgren Lawrence stage 1 to stage 4 - Unilateral or Bilateral Knee Osteoarthritis - Patient who are willing to participate Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conservational Physical Therapy and Proprioceptive Strength Training
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 Training
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.

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 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. 12th Week
Primary 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. 12th Week
Primary 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. 12th Week
Primary 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. 12th Week
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