Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength in Knee Osteoarthritis
Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength Training on Pain, Gait Variability, and Functional Outcome in Knee Osteoarthritis: A Randomized Controlled Trial
The current study is a single-blinded, parallel-group pilot randomized controlled trial involving 20 participants diagnosed with knee osteoarthritis (KOA). The trial will compare the effects of a knee and heel off-loader brace combined with non-weight bearing (NWB) strength training versus a conventional knee off-loader brace combined with NWB strength training. Interventions will be delivered three times per week for four weeks.
The primary outcome of the study is pain intensity, while secondary outcomes include gait variability and functional outcome. Assessments will be conducted at baseline and after completion of the intervention period. The study will be carried out at the outpatient physiotherapy departments of Kaazi Hospital and Ghurki Trust Hospital, Lahore.
The hypothesis is that the combination of knee and heel off-loader brace with NWB strength training will result in greater reductions in pain, improved gait variability, and enhanced functional outcomes compared to the conventional knee off-loader brace with NWB strength training.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
KOA is a degenerative joint disorder characterized by progressive cartilage breakdown, joint pain, stiffness, muscle weakness, and impaired functional mobility. One of the key biomechanical issues in KOA is increased medial compartment loading, which contributes to disease progression and functional limitations. Additionally, individuals with KOA commonly exhibit altered gait patterns and increased gait variability, reflecting impaired neuromuscular control and increased risk of falls.
Conservative management strategies for KOA primarily focus on pain reduction, improving joint function, and enhancing quality of life. Among these, biomechanical interventions such as knee off-loader braces aim to redistribute joint loading, while strengthening exercises target neuromuscular deficits. However, traditional weight-bearing exercises may increase joint stress and pain, making NWB strength training a safer and more effective alternative.
Knee and heel off-loader braces have been introduced as an advanced biomechanical intervention designed to reduce joint loading by altering lower limb alignment and redistributing forces away from the affected knee compartment. While these braces effectively address mechanical stress, they do not directly improve muscle strength and neuromuscular control. Conversely, NWB strength training improves muscular support and joint stability but does not correct abnormal loading patterns.
Despite the individual effectiveness of these interventions, limited research has explored their combined effect. Therefore, this study aims to evaluate the synergistic impact of combining knee and heel off-loader brace with NWB strength training on pain, gait variability, and functional outcome in KOA.
This study will adopt a single-blinded, two-arm parallel randomized controlled design. A total of 20 participants will be randomly allocated into two groups. The experimental group will receive a knee and heel off-loader brace along with a structured NWB strength training program, while the control group will receive a conventional knee off-loader brace with the same exercise protocol.
The intervention will be conducted over four weeks, with three sessions per week. Outcome measures will include the Numeric Pain Rating Scale (NPRS) for pain, the JACK scale for gait variability, and the Knee Injury and Osteoarthritis Outcome Score (KOOS) for functional assessment.
The study aims to determine whether combining biomechanical off-loading with neuromuscular strengthening provides superior clinical benefits. It is expected that this integrated approach will lead to greater pain reduction, improved gait stability, and enhanced functional performance, thereby contributing to evidence-based rehabilitation strategies for individuals with knee osteoarthritis.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: MUHAMMAD TARIQ RAFIQ, PhD
- Correo electrónico: rafiqmuhammadtariq149@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Jabar Ali, MSPT
- Número de teléfono: 03164680178
- Correo electrónico: jabaralijabar5617@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Clinically diagnosed KOA with radiographic Kellgren and Lawrence grade II-III, confirmed within the previous six months
- History of knee pain for at least three months, consistent with chronic KOA
- Ability to ambulate independently, with or without assistive devices
- No change in pharmacological management for KOA during the previous three months
- Ability to understand instructions and complete self reported outcome measures
- Willingness to participate and provision of written informed consent
Exclusion Criteria:
- Severe venous insufficiency or history of deep vein thrombosis
- Acute inflammatory knee conditions (e.g., septic arthritis, acute synovitis)
- Rheumatic or systemic inflammatory joint diseases (e.g., rheumatoid arthritis)
- Traumatic onset of knee pain within the previous six months
- History of major lower limb injury or surgery requiring rehabilitation within the past year
- Neurological or neurodegenerative disorders affecting gait or balance, including Parkinson's disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: EXPERIMENTAL GROUP
Participants in the experimental group will receive a structured intervention consisting of two integrated components: knee and heel off-loader brace for approximately 6-8 hours per day as tolerated and NWB strength training exercises three times per week for four weeks each session lasting approximately 45-60 minutes.
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Participants in the experimental group will receive a combined intervention of knee and heel off-loader brace along with a structured NWB strength training program.
The exercise program will be conducted three times per week for four weeks, with each session lasting approximately 45-60 minutes.
Exercises will include quadriceps isometrics, straight leg raises, short arc quadriceps, hamstring curls, hip abduction, and glute bridging.
Progression will be based on patient tolerance.
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Comparador activo: CONTROL GROUP
Participants in the control group will receive a conventional knee off-loader brace combined with the same NWB strength training program.
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Participants in the control group will receive a conventional knee off-loader brace combined with the same NWB strength training program instead of Knee and Heel Off-Loader Brace .
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity
Periodo de tiempo: Baseline and after 4 weeks of intervention
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Pain intensity refers to the subjective perception of knee pain experienced by individuals with knee osteoarthritis.
In this study, pain will be measured using the Numeric Pain Rating Scale (NPRS) an 11-point self reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates worst imaginable pain.
Participants will be asked to rate their pain at rest, during walking, and during daily functional activities.
The NPRS is a reliable and valid tool commonly used in musculoskeletal conditions and demonstrates excellent test retest reliability and strong construct validity.
The primary objective is to evaluate the reduction in pain intensity following the intervention.
A decrease in NPRS scores after the intervention period will indicate improvement in pain
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Baseline and after 4 weeks of intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gait Variability
Periodo de tiempo: Time Frame: Baseline and after 4 weeks of intervention
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Gait variability refers to the natural step-to-step fluctuations in walking patterns and is an important indicator of gait stability, neuromuscular control, and fall risk.
Individuals with knee osteoarthritis often demonstrate increased gait variability due to pain, joint instability, and impaired coordination.
In this study, gait variability will be assessed using the JACK Scale, an observational gait assessment tool.
Participants will walk along a standardized 10-meter walkway at a comfortable speed, and the assessor will evaluate parameters such as step length consistency, stride symmetry, stance-swing control, and postural stability.
Scores will be assigned based on observed deviations, with higher scores indicating greater gait instability and variability.
The JACK Scale has demonstrated good reliability and validity in clinical settings.
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Time Frame: Baseline and after 4 weeks of intervention
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Functional Outcome
Periodo de tiempo: Time Frame: Baseline and after 4 weeks of intervention
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Functional outcome refers to the ability of an individual to perform daily activities, maintain mobility, and participate in physical tasks.
In this study, functional outcome will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS).
The KOOS is a validated patient-reported outcome measure consisting of five subscales: Pain, Symptoms, Activities of Daily Living (ADL), Sport and Recreation, and Quality of Life.
The ADL subscale will be primarily used to assess functional performance in daily activities such as walking, stair climbing, standing, and bending.
Scores are transformed to a 0-100 scale, where higher scores indicate better functional ability and lower disability
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Time Frame: Baseline and after 4 weeks of intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Muhammad Tariq Rafiq, PhD, Lahore University of Biological & Applied Sciences
Fechas de registro del estudio
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Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- DGRC/MSPT/26/731
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Marco de tiempo para compartir IPD
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- PROTOCOLO DE ESTUDIO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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