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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Universidade Federal de Sao Carlos
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Glauko André de Figueiredo Dantas
Principal Investigator (MSc)
Universidade Federal de Sao Carlos
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
Time Frame: Baseline, 8 weeks 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.
Secondary Outcomes
- 30-second Chair Stand Test(Baseline, 8 weeks and 16 weeks.)
- 9-step Stair Climb Test(Baseline, 8 weeks and 16 weeks.)
- Foot strength(Baseline, 8 weeks and 16 weeks.)
- Foot Kinematics during gait(Baseline, 8 weeks and 16 weeks.)
- Paracetamol intake(Baseline, 8 weeks and 16 weeks.)
- Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.(Baseline, 8 weeks and 16 weeks.)
- Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.(Baseline, 8 weeks and 16 weeks.)
- Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks(Baseline, 8 weeks and 16 weeks.)
- 40m (4x10m) Fast Paced Walk Test(Baseline, 8 weeks and 16 weeks.)
- Knee joint moments during gait(Baseline, 8 weeks and 16 weeks.)
- Global Rating of Change Scale(8 weeks and 16 weeks.)