NCT05258227

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

February 20, 2022

Last Update Submit

April 21, 2022

Conditions

Keywords

Proprioceptive TrainingCore InstabilityStrength TrainingKnee OsteoarthritisRandomized Control TrialBalancePhysical Functions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

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

Other: Conservational Physical Therapy and Core Instability Strength Training

Interventions

The proprioceptive training cycle consist of squats, single leg stand, slide steps , forward and backward step, toe walking , heel walking , side sway etc.

Proprioceptive 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.

Core Instability Strength Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Knee Osteoarthritis disease
  • Kellgren Lawrence stage 1 to stage 4
  • Unilateral or Bilateral Knee Osteoarthritis
  • Patient who are willing to participate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The study will be double blinded as the assessors and the subjects of the study are kept blind towards the treatment group to which patients are allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

February 28, 2022

Study Start

March 1, 2021

Primary Completion

March 25, 2022

Study Completion

March 28, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations