Soft Knee Brace Versus Lateral Wedge in Knee Osteoarthritis

NCT06836934 | Enrolling By Invitation DMC

• 1 other identifier: P.T.REC/012/005582
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of study is to investigate the efficacy of soft knee brace versus lateral wedge foot insole on pain and proprioception in knee OA

Conditions

Knee Osteoarthristis

Keywords

knee osteoarthritis soft knee brace lateral wedge foot insole; proprioception pain

Outcome Measures

Primary Outcomes (1)

• pain intenisty

  The visual analog scale (VAS) is the VAS, which consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that could possibly feel (10)

  2 months

Secondary Outcomes (3)

• proprioception

  2 months

• physical function

  2 months

• range of motion

  2 months

Study Arms (3)

conventional physical therapy

ACTIVE COMPARATOR

the patient will receive treatment For 8weeks three times a week Strengthening Exercises: * Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint. * Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee. * Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). Flexibility Exercises: * Hamstring Stretch: Gentle stretching of the hamstrings can alleviate tension around the knee. * Quadriceps Stretch: Stretches like the standing quadriceps stretch help maintain flexibility in the front of the thigh. * Calf Stretch: Stretching the calf muscles can prevent tightness TENS (Transcutaneous Electrical Nerve Stimulation): Helps manage pain by sending electrical impulses to the affected area.

Procedure: convential physical therapy program

soft knee brace

EXPERIMENTAL

the patient will Wear soft knee brace for 8 weeks plus traditional physical therapy A commercially available soft brace (orthopedics ser. number 86) plus traditional physiotherapy The patient will wear the brace brace except for sleeping A tight brace was defined as one that was fitted based on shank and thigh circumferences measured according to instructions provided by the distributor (standard fit). A non-tight brace was defined as being 1 size larger than a tight brace. plus conventional therapy Strengthening Exercises: * Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint. * Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee. * Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). (Deyle et al ., 2005) Flexibil

Device: soft knee brace; Procedure: convential physical therapy program

lateral wedge foot insole

EXPERIMENTAL

the patient will wear Lateral wedge insole 5mm for 8 weeks plus traditional physical therapy Standardized non-customized laterally wedged insoles were evaluated. Insoles were made of high-density ethyl vinyl acetate, were wedged approximately 5° (as greater wedging is associated with foot discomfort and were worn inside the participant's own shoes. In loaded positions ,The insoles were wedged along the lateral edge of the entire length of the foot. Strengthening Exercises: * Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint. * Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee. * Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). (Deyle et al ., 2005) Flexibility Exercises: • Hamstring Stretch: Gentle stretc

Device: lateral wedge foot insole; Procedure: convential physical therapy program

Interventions

soft knee brace DEVICE

A commercially available soft brace (orthomedics ser. number 86) plus traditional physiotherapy

soft knee brace

lateral wedge foot insole DEVICE

Wearing Lateral wedge insole 5mm for 8 weeks Standardized non-customized laterally wedged insoles were evaluated. Insoles were made of high-density ethyl vinyl acetate, were wedged approximately 5°

lateral wedge foot insole

convential physical therapy program PROCEDURE

Strengthening Exercises: * Quadriceps Strengthening: Exercises like straight leg raises, quadriceps sets, and seated knee extensions help strengthen the quadriceps muscle, which supports the knee joint. * Hamstring Strengthening: Hamstring curls and bridges target the hamstrings to enhance stability and support for the knee. * Hip Strengthening: Exercises such as hip abductions, adductions, and clamshells strengthen the hip muscles (each 3 sets, 10 reps). (Deyle et al ., 2005) Flexibility Exercises: * Hamstring Stretch: Gentle stretching of the hamstrings can alleviate tension around the knee. * Quadriceps Stretch: Stretches like the standing quadriceps stretch help maintain flexibility in the front of the thigh. * Calf Stretch: Stretching the calf muscles can prevent tightness (J. D. Deyle et al 2005) TENS (Transcutaneous Electrical Nerve Stimulation): Helps manage pain by sending electrical impulses to the affected area.

conventional physical therapy; lateral wedge foot insole; soft knee brace

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Their ages range from 40-60 years old.
• The patients included to this study according to American College of Rheumatology (ACR) criteria, namely, knee pain; and/or morning stiffness longer than 30 minutes and/or joint crepitus.
• The patients Kellgren Lawrence scores grade II-IV.
• All the patients included had a minimum score of 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores.
• Unilateral symptomatic knee.

You may not qualify if:

• \. high tibial osteotomy other realignment surgery 2. knee replacement 3. knee arthroscopy within the last 6 months. 4. an intraarticular injection within the past 3 months. 5. rheumatoid arthritis or patellofemoral syndrome 6. diabetic neuropathic pain or fibromyalgia. 7. foot or ankle problems that contraindicated the use of load-modifying interventions in footwear 8. body mass index (BMI) ≥35 kg/m2.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Universty

Giza, Giza Governorate, 0, Egypt

Location

Study Officials

• omar ha abdelmoamen el sayed

  cairo universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: soft knee brace and lateral wedge foot insole

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: October 15, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 26, 2025
• Last Updated: February 20, 2025

Record last verified: 2024-11

Locations

EG (1)