NCT06343909

Brief Summary

The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups. Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 4, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

March 25, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

Knee Osteoarthritis, KOOS, Strengthening Exercises

Outcome Measures

Primary Outcomes (2)

  • Knee Osteoarthritis Outcome Score (KOOS)

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury.A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems).

    8 weeks

  • Berkemann foot prints

    For arch measurement, the longitudinal and horizontal arch lengths were recorded for the left and right feet to create a static standing position using a Berkemann footprint

    8 weeks

Secondary Outcomes (6)

  • Frontal plane projection

    8 weeks

  • Goniometer

    8 weeks

  • 30 seconds chair stand test

    8 weeks

  • Overall self-perception by Global Rating of Change Score

    8 weeks

  • 9 step stairs climb test.

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Hip abductor strengthening exercise along with conventional exercises

ACTIVE COMPARATOR

Hip abductor strengthening Participant was positioned in side lying with bottom leg hip abducting to a 45-degree and knee in flexion. The uppermost leg was actively abducted while it remains in slight extension making sure no rotation occurred. Participant was instructed to hold the leg in that position for 5-10 seconds and then to lower it to resting position. Participant was instructed to repeat the exercise with weight cuff attached to the proximal part of ankle

Other: Hip abductor strengthening exercise

intrinsic foot muscle strengthening exercise along with conventional exercises

ACTIVE COMPARATOR

Wring towel with feet: . Patient in sitting position, place a hand towel flat on the floor pull the towel towards your heel. Grapping object with toes: Sitting, place the object flat on the floor. . Hold it for a second and then according to the resistance of the release it. Toe abduction (hallux and 2nd toe): Sitting place a small band between the hallux and second toe. Open and separate your toe and then squeeze the toe against the resistance of elastic. Always leave your feet resting on the floor.. Toggle toe support: Sitting with feet resting on the floor, alternately touch the first and fifth toes on the floor. Be careful not to move your knees.

Other: Intrinsic foot muscle strengthening along with conventional exercises

Interventions

in this group 15 participants will perform hip abductor streghtning along with conventional exercises .protocol for 8 weeks 24 sessions (3 sessions in a weak) and 10 sec rest between each segment,3 sets and 10 reputations will be performed.

Also known as: conventional exercises
Hip abductor strengthening exercise along with conventional exercises

in this group 15 participants will perform Intrinsic foot muscle strengthening along with conventional exercises .protocol for 8 weeks 24 sessions (3 sessions in a weak) and 10 sec rest between each segment,3 sets and 10 repitations will be performed.

intrinsic foot muscle strengthening exercise along with conventional exercises

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pain at medial side of the knee.
  • patient can walk without walking aids.

You may not qualify if:

  • patient with previous hip, knee and ankle surgery.
  • patient who received intraarticular injection.
  • patient with neurologic and muscle problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

THQ hospital KRK.

Lahore, Punjab Province, Pakistan

Location

Related Publications (5)

  • Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Lyles M, Guermazi A, Bennell KL, Loeser RF. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):646-657. doi: 10.1001/jama.2021.0411.

    PMID: 33591346BACKGROUND
  • Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.

    PMID: 32978204BACKGROUND
  • Samuel AJ, Kanimozhi D. Outcome measures used in patient with knee osteoarthritis: With special importance on functional outcome measures. Int J Health Sci (Qassim). 2019 Jan-Feb;13(1):52-60.

    PMID: 30842718BACKGROUND
  • Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.

    PMID: 24707086BACKGROUND
  • Kim I, Kim HA, Seo YI, Song YW, Hunter DJ, Jeong JY, Kim DH. Tibiofemoral osteoarthritis affects quality of life and function in elderly Koreans, with women more adversely affected than men. BMC Musculoskelet Disord. 2010 Jun 22;11:129. doi: 10.1186/1471-2474-11-129.

    PMID: 20569450BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Muhammad Sanaullah, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 3, 2024

Study Start

November 23, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

September 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations