Foot Wear Modification Along With Physical Therapy in Knee Osteoarthritis

NCT ID: NCT04536519

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-05
• Study Completion Date: 2022-03-29

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.

Detailed Description

2.1 MULTIDISCIPLINARY TEAM APPROACH As defined by World Health Organization, Curriculum Contents and International Practice Patterns, physical therapy is an autonomous profession where clinical make clinical decisions based on clinical reasoning, differentially diagnose, determine prognosis, and make plan of care including discharge planning and outcome assessment.

Orthotics and Prosthetics are important areas where physiotherapist order 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 establishing role of foot wear modification as adjunct treatment protocol for knee osteoarthritis but also elicit a multidisciplinary team approach which is a much needed area especially in emergency rehabilitation area.

2.2 LITERATURE GAP Although, there is work on performance of modified foot wears, which have been studied mostly alone or as adjunct with pharmacology. There is less literature on conservative treatment of osteoarthritis with foot wear modification coupled with physiotherapy treatment. This study will create a unique impact paying ways for type of preferable footwear that should be used, based on results, and combining treatment with physiotherapy care.

2.3 UNSETTLED DEBATE OVER TYPE OF FOOTWEAR The debate is still underway, worldwide, regarding which shoe type or foot wear should be preferred over other. The study results will come up with a contribution towards determining right foot wear for osteoarthritis.

2.4 COST EFFECTIVENESS The knee osteoarthritis is a problem that degenerative in nature and is triggered due to posture and abnormal force distribution. Right shoes are proven to alter walk posture, step length and degree of ease in walk. This simple remedy can be integral for reduction in care cost by minimizing disability and pain.

2.5 NOVEL SHOE MAKING APPROACH Although, advising foot wears and its modification is technical phenomenon, yet, this study can impact formulation of a shoe pattern that can help the arthritis patients. This can open new shoe making approach on public shoe outlets, from where old age individuals can directly buy the shoes that be the potential healer and disease modifier.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lateral Heel Wedged Insole Alone with physical therapy

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.

Group Type: ACTIVE_COMPARATOR

osteoarthritis management

Intervention Type: 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.

Lateral aand medial Heel Wedged Insole with physiotherapy

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

Group Type: ACTIVE_COMPARATOR

osteoarthritis management

Intervention Type: 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.

Interventions

osteoarthritis management

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.

Intervention Type: OTHER

Other Intervention Names

physical therapy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isra University

OTHER

Sponsor Role: lead

Responsible Party

Usman janjua

director Janjua rehab center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Janjua Rehab Center, Gujranwala

Chak One Hundred Seventy-five Nine Left, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

1502-PHD-001

Identifier Type: -

Identifier Source: org_study_id