Effect of Lateral Wedged Insoles With Subtalar Strapping on Genu Varum With Medial Compartment Knee Pain

NCT06632639 | Recruiting

• 1 other identifier: P.T.REC/012/005074
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the effect of lateral wedged insoles with subtalar strapping in genu varum with medial compartment knee pain on:

1. 1.Space between knees (measured by vernier calipers)
2. 2.Degree of genu varum deformity (Femorotibial angle (FTA)) measured on long film weight bearing x-ray)
3. 3.Pain level (Measured by VAS)
4. 4.Hind foot angle (measured by long axial hindfoot alignment view)
5. 5.Functional outcome (measured by the lower extremity function scale)
6. 6.Functional performance (measured by the 6 minute walk test)

Conditions

Genu Varum

Outcome Measures

Primary Outcomes (1)

• Distance between knees using vernier calipers

  To measure the distance between the participants' knees, we have them put both feet together, so that both malleolus bones were together, and measured the space between the tibia and medial condyle using vernier calipers.

  12 weeks

Secondary Outcomes (5)

• Degree of genu varum deformity measured by long film weight bearing X-Ray

  12 weeks

• Pain level measured by the visual analogue scale (VAS)

  12 weeks

• Hind foot angle measured by long axial hindfoot alignment view

  12 weeks

• Functional outcome measured by lower extremity function scale (LEFS)

  12 weeks

• Functional performance measured by the 6 minute walk test

  12 weeks

Study Arms (2)

Corrective exercise protocol + Lateral wedged insoles with subtalar strapping

EXPERIMENTAL

They will receive the corrective exercise protocol in addition to the lateral wedged insoles with subtalar strapping for 12 weeks.

Other: Corrective exercise protocol; Other: Lateral wedged insoles with subtalar strapping

Corrective exercise protocol

ACTIVE COMPARATOR

They will receive the same corrective exercise protocol alone for 12 weeks.

Other: Corrective exercise protocol

Interventions

Corrective exercise protocol OTHER

The program requires 60 minutes consisting of a ten-minute warm-up, a forty-minute Thera-band exercise, and a ten-minute cool-down. Thera-band exercises are to improve the external rotators, and the extensors and for strengthening the quadriceps and the gluteus. A set consists of 15 reps, each of the exercise methods consisted of three sets.

Corrective exercise protocol; Corrective exercise protocol + Lateral wedged insoles with subtalar strapping

Lateral wedged insoles with subtalar strapping OTHER

A silicon rubber 10 mm lateral wedge has a 10 mm lateral elevation and a 75 mm width, which has an approximately 7.6 inclination. This silicon rubber material is usually used for cosmetic remodeling and has a natural form-fit to the skin. The 75 mm width silicon rubber is scaphoid shaped and it is suitable for attachment to a barefoot of all of the subjects. The rational for using this inclination is that 7.6 is approximately the median between 5 and 10. Patients will be instructed to use the wedge in an appropriate shoe (not high heels or narrow-toed shoes), 1 h a day during the first week. The duration of use gradually will be increased to the minimum of 8 h a day.

Corrective exercise protocol + Lateral wedged insoles with subtalar strapping

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both genders aged 20-60.
• Patients with medial compartment pain. Pain level of 3 or more on the VAS.
• Patients with varus deformity are defined as those Those whose femorotibial angle measures 5-10 degrees of genu varum on long film weight bearing x-ray.
• Patients with grade one O.A. on Kellgren-Lawrence classification system or without O.A.
• BMI less than 35
• Patients with decompensated hind foot (hind foot varus)

You may not qualify if:

• Patients already wearing custom wedged insoles.
• Patients with other inflammatory conditions like rheumatoid arthritis or systematic inflammatory arthritis.
• Patients with central or peripheral nervous system disease.
• Any previous surgical procedure to the knee joint.
• Patients who are unable to walk without assistance (cane or a walker).
• Pregnancy
• Uncooperative patient types due to mental disorders or others.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Genu Varum

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Abeer Abdulrahman, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Ali Abdelmoniem Ali Hassanien, B.Sc

CONTACT

01555429409; ali.hassanien1993@gmail.com

Abeer Abdulrahman, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: November 12, 2024
• Primary Completion: October 12, 2025
• Study Completion: October 31, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

EG (1)