Foot Wear Modification Along With Physical Therapy in Knee Osteoarthritis

NCT04536519 | Completed

• 1 other identifier: 1502-PHD-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Orthotics and Prosthetics are important areas where physiotherapists order a variety of assistive aids to restore, compensate, or prevent physical ailments and disorders, such as here, Knee Osteoarthritis. This study will be helpful not only in establishing the role of footwear modification as an adjunct treatment protocol for knee osteoarthritis but also elicit a multidisciplinary team approach which is a much-needed area, especially in the emergency rehabilitation area.

Conditions

Osteo Arthritis Knee

Keywords

osteoarthritis; knee joint

Outcome Measures

Primary Outcomes (3)

• knee osteoarthritis outcome score

  questionaire used to evaluate charecteristics of knee joint

  24 week

• The Western Ontario and McMaster Universities Osteoarthritis Index

  questionaire used to evaluate charecteristics of knee joint

  24 week

• Short Form 36 Health Survey Questionnaire

  The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions. Culture-specific data are required to calculate SF-36 norm-based scores.

  24 week

Secondary Outcomes (1)

• Manual Muscle Testing

  24 week

Study Arms (2)

Lateral Heel Wedged Insole Alone with physical therapy

ACTIVE COMPARATOR

the lateral heel wedged insole (19) comprised non-custom, high density based on insoles of ethyl-vinyl acetate distributed bilaterally, preferably, covered in leather, were used in the study. The insole were equipped with a lateral wedge of 50 to 60. In the case of unilateral knee osteoarthritis, the non-wedge insole were used to compensate for possible leg length discrepancy in the contra-lateral leg. Shoes used was based on gymnast type to keep wedge insole in place. This further finalized individual to individual with unanimous decisions of Cordwainers, orthotics, and principal researcher, physiotherapist.

Other: osteoarthritis management

Lateral aand medial Heel Wedged Insole with physiotherapy

ACTIVE COMPARATOR

medial arch support part were combine with aforementioned lateral heel wedged support, full length support. There is a debate, however, 4 to 6 mm of full length support is considered to be effective for required alteration in mechanics

Other: osteoarthritis management

Interventions

osteoarthritis management OTHER

The conventional physical therapy will be consisted of an array of protocols being deployed in parallel. This will consist of * Patient education regarding deforming forces, strategies of prevention and home exercise program * Decreasing stiffness by controlled active range of motion and mobilization techniques involving join play. * Mechanical stresses will be controlled in form of support provided by foot wear modification * Range of motion will be increased muscle stretches and manual mobilization techniques * Muscle performance and neuromuscular control will be addressed by gentle exercises of low intensity and repetitive exercises. * Balance improvement by employing balance training activities as part of treatment * Physical conditioning low impact or non-impact aerobics This conventional exercise will be given as baseline treatment to both of groups.

Also known as: physical therapy

Lateral Heel Wedged Insole Alone with physical therapy; Lateral aand medial Heel Wedged Insole with physiotherapy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both gender
• diagnosed patient with knee osteoarthritis on clinical and radiographic basis,
• aged 50 years or above,
• knee pain from at least one month with an intensity equal or more than 4 on 11 points Numeric rating pain scale,
• falling between grade 2-3 on Kellgren-Lawrence Classification System for knee osteoarthritis,
• having BMI range between 22-25 kg/m2 and participating in study with their own will with a signed consent form.

You may not qualify if:

• trauma in knee region,
• having knee or lower limb surgery for fracture or arthroplasty,
• getting steroid based intra-articular injection or physiotherapy treatment in last 6 months,
• getting lidocaine intra-articular injection in last one month, with condition of systemic arthritic condition, severe co-morbidities or
• serious medical conditions or systemic disease causing dependent edema making difficult to wear foot wear in open or close shoes.

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Janjua Rehab Center, Gujranwala

Gujranwala, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: It was a double blinded study in which assessors and patientswere blinded. Close shoe type make it possible to blind patients because receiving identical conventional treatment in both groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director Janjua rehab center

Model Details: a randomized controlled trial with 2 group

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 2, 2020
• Study Start: October 5, 2019
• Primary Completion: December 10, 2021
• Study Completion: March 29, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)