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

NCT ID: NCT04154059

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2023-08-04

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.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

Intervention Group

Patients will receive a physical therapy intervention three times per week, for 8 weeks.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: OTHER

Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.

Control Group

Patients will not receive any exercise treatment but they will keep their recommended clinical treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention Group

Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.

Intervention Type: OTHER

Other Intervention Names

Foot and ankle kinesiotherapy

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Glauko André de Figueiredo Dantas

Principal Investigator (MSc)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Glauko Dantas

São Carlos, São Paulo, Brazil

Countries

Brazil

References

Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.

Reference Type: RESULT

PMID: 32978204 (View on PubMed)

Dantas GAF, Sacco ICN, Ferrari AV, Matias AB, Watari R, Oliveira LVM, Marcon TR, Fatore JA, Pott-Junior H, Salvini TF. Effects of a foot-ankle muscle strengthening program on pain and function in individuals with knee osteoarthritis: a randomized controlled trial. Braz J Phys Ther. 2023 Jul-Aug;27(4):100531. doi: 10.1016/j.bjpt.2023.100531. Epub 2023 Aug 11.

Reference Type: RESULT

PMID: 37603935 (View on PubMed)

Other Identifiers

LabPlastUFSCar

Identifier Type: -

Identifier Source: org_study_id