Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis

Study Overview
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Brief Summary
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The main objective of this trial is To evaluate the effect of an ankle and foot muscle strengthening program on pain, analgesic consumption, functionality, and lower limb biomechanics during gait in individuals with knee osteoarthritis.

Detailed Description
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A randomized controlled trial will be performed with 76 patients with knee osteoarthritis. The participants will be randomly assigned into either a control group (no exercises; they will keep their recommended clinical treatment) or an intervention group which will receive 8-week physical therapy exercises, three times per week, under the supervision of a physiotherapist. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty. The subjects will be evaluated in 3 different moments (Baseline, immediately after treatment and 8 weeks follow-up). The hypothesis of this study is that the intervention group will decrease pain and medication intake, and improve functional performance, increase isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group.

Official Title
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Effects of a Strengthening Program for Foot-ankle Muscles in Clinical Aspects and Gait Biomechanics of People With Knee Osteoarthritis: a Randomized Blinded Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee osteoarthritis (KOA) based on clinical and radiological criteria of American College of Reumathology; KOA (Grade II and III - Radiological classification of Kellgreen and Laurence) in medial compartment of knee; Knee pain between 30 and 80 on the visual analogue scale; BMI < 35 kg/m2. Exclusion Criteria: KOA isolated (Grade II and III - Radiological classification of Kellgreen and Laurence) in lateral compartment of knee; Lower limb strength training (3 times per week); Wear minimalist shoes for at least 6 hours a day and 5 days a week; Physical therapy in the previous 3 months; Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively; Previous history of surgery on knees, ankles and hips in the last 2 years; Neurological disease; Inflammatory arthritis (eg. rheumatoid arthritis); Asymptomatic OA of one or both knees.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patients will receive a physical therapy intervention three times per week, for 8 weeks. | Other: Intervention Group<br>* Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.<br>* Other names: Foot and ankle kinesiotherapy;|
| No Intervention: Control Group<br>Patients will not receive any exercise treatment but they will keep their recommended clinical treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks. | The WOMAC pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain. | Baseline, 8 weeks and 16 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks. | The stiffness subscale included in the WOMAC index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function. | Baseline, 8 weeks and 16 weeks. | 
| Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks. | he physical function subscale included in the WOMAC index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations. | Baseline, 8 weeks and 16 weeks. | 
| Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks | The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. | Baseline, 8 weeks and 16 weeks. | 
| 30-second Chair Stand Test | The maximum number of chair stand repetitions possible in a 30 second period. | Baseline, 8 weeks and 16 weeks. | 
| 9-step Stair Climb Test | The time (in seconds) it takes to ascend and descend a flight of stairs. Where possible, the 9-step stair test with 20cm (8 inch) step height and handrail is recommended. | Baseline, 8 weeks and 16 weeks. | 
| 40m (4x10m) Fast Paced Walk Test | A test of walking speed over short distances and changing direction during walking. A fast-paced walking test that is timed over 4 x 10m for a total 40 m (convert time to speed). | Baseline, 8 weeks and 16 weeks. | 
| Foot strength | Hallux and lesser toes force measured by a pressure plate | Baseline, 8 weeks and 16 weeks. | 
| Foot Kinematics during gait | Foot joints and plantar arch motion during gait.The kinematics outcomes will be evaluate by mean inverse dynamics approach. To this procedure, we will use the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. | Baseline, 8 weeks and 16 weeks. | 
| Knee joint moments during gait | Peak joint moment by inverse dynamic calculations. To this procedure, we will use the kinematics and kinetics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. | Baseline, 8 weeks and 16 weeks. | 
| Global Rating of Change Scale | GRCS assesses the clinical change perceived by the patient by comparing the onset of symptoms before and after treatment. With respect to your knee injury, how do you describe your situation now compared to the start of treatment? This numerical scale consists of 11 points (from -5 to +5: -5, extremely worse; 0, unchanged; +5, fully recovered). Higher scores indicate better recovery from the condition. | 8 weeks and 16 weeks. | 
| Paracetamol intake | Paracetamol intake (500 mg), number of tablets per month. | Baseline, 8 weeks and 16 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Arthrosis, Therapeutic exercises, Feet