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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154059
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Glauko André de Figueiredo Dantas, Universidade Federal de Sao Carlos

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Intervention Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Patients will receive a physical therapy intervention three times per week, for 8 weeks.
Other: Intervention Group
Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.
Other Name: Foot and ankle kinesiotherapy

No Intervention: Control Group
Patients will not receive any exercise treatment but they will keep their recommended clinical treatment.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks. [ Time Frame: Baseline, 8 weeks 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.

  2. Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks. [ Time Frame: Baseline, 8 weeks 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.

  3. Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks [ Time Frame: Baseline, 8 weeks 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.

  4. 30-second Chair Stand Test [ Time Frame: Baseline, 8 weeks and 16 weeks. ]
    The maximum number of chair stand repetitions possible in a 30 second period.

  5. 9-step Stair Climb Test [ Time Frame: Baseline, 8 weeks and 16 weeks. ]
    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.

  6. 40m (4x10m) Fast Paced Walk Test [ Time Frame: Baseline, 8 weeks and 16 weeks. ]
    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).

  7. Foot strength [ Time Frame: Baseline, 8 weeks and 16 weeks. ]
    Hallux and lesser toes force measured by a pressure plate

  8. Foot Kinematics during gait [ Time Frame: Baseline, 8 weeks and 16 weeks. ]
    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.

  9. Knee joint moments during gait [ Time Frame: Baseline, 8 weeks and 16 weeks. ]
    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.

  10. Global Rating of Change Scale [ Time Frame: 8 weeks and 16 weeks. ]
    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.

  11. Paracetamol intake [ Time Frame: Baseline, 8 weeks and 16 weeks. ]
    Paracetamol intake (500 mg), number of tablets per month.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154059


Contacts
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Contact: Tania Salvini, PhD +551633518345 taniasalvini2015@gmail.com
Contact: Glauko Dantas, Ms +5516992156105 glauko.ft.andre@hotmail.com

Locations
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Brazil
Glauko Dantas Recruiting
São Carlos, São Paulo, Brazil
Contact: Glauko Dantas, MSc       glauko.ft.andre@hotmail.com   
Sponsors and Collaborators
Universidade Federal de Sao Carlos
University of Sao Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glauko André de Figueiredo Dantas, Principal Investigator (MSc), Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT04154059    
Other Study ID Numbers: LabPlastUFSCar
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data collected during the trial will be compiled electronically. Data integrity and validity will be verified at the time of data entry (edit checks). The project manager and research assistant will regularly monitor the study datasets and make recommendations regarding necessary protocol modifications or termination of all or part of the study. Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication. In addition, the study protocol and clinical trial report (both with the planned statistical analysis) will be made available by the researchers who proposed the methodology. Requests for data or any form of analysis should be directed to glauko.ft.andre@hotmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication.
Access Criteria: Requests for data or any form of analysis should be directed to glauko.ft.andre@hotmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glauko André de Figueiredo Dantas, Universidade Federal de Sao Carlos:
Rehabilitation
Arthrosis
Therapeutic exercises
Feet
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases