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

Primary Purpose

Knee Osteoarthritis

Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention Group
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Rehabilitation, Arthrosis, Therapeutic exercises, Feet

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glauko Dantas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
30-second Chair Stand Test
The maximum number of chair stand repetitions possible in a 30 second period.
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.
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).
Foot strength
Hallux and lesser toes force measured by a pressure plate
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.
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.
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.
Paracetamol intake
Paracetamol intake (500 mg), number of tablets per month.

Full Information

First Posted
October 31, 2019
Last Updated
May 16, 2022
Sponsor
Universidade Federal de Sao Carlos
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04154059
Brief Title
Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Why Stopped
The recruitment of potential participants is suspended due to the covid-19 pandemic.
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Rehabilitation, Arthrosis, Therapeutic exercises, Feet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Patients will receive a physical therapy intervention three times per week, for 8 weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will not receive any exercise treatment but they will keep their recommended clinical treatment.
Intervention Type
Other
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
Foot and ankle kinesiotherapy
Intervention Description
Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.
Primary Outcome Measure Information:
Title
Change from baseline The WOMAC (Western Ontario and McMaster Universities) Pain Subscale at 8 and 16 weeks.
Description
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.
Time Frame
Baseline, 8 weeks and 16 weeks.
Secondary Outcome Measure Information:
Title
Change from baseline WOMAC (Western Ontario and McMaster Universities) Stiffness Subscale at 8 and 16 weeks.
Description
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.
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
Change from baseline WOMAC (Western Ontario and McMaster Universities) Physical Function Subscale at 8 and 16 weeks.
Description
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.
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
Change from baseline WOMAC (Western Ontario and McMaster Universities) Total Score at 8 and 16 weeks
Description
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.
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
30-second Chair Stand Test
Description
The maximum number of chair stand repetitions possible in a 30 second period.
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
9-step Stair Climb Test
Description
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.
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
40m (4x10m) Fast Paced Walk Test
Description
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).
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
Foot strength
Description
Hallux and lesser toes force measured by a pressure plate
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
Foot Kinematics during gait
Description
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.
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
Knee joint moments during gait
Description
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.
Time Frame
Baseline, 8 weeks and 16 weeks.
Title
Global Rating of Change Scale
Description
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.
Time Frame
8 weeks and 16 weeks.
Title
Paracetamol intake
Description
Paracetamol intake (500 mg), number of tablets per month.
Time Frame
Baseline, 8 weeks and 16 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Glauko Dantas
City
São Carlos
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication.
IPD Sharing 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.
Citations:
PubMed Identifier
32978204
Citation
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.
Results Reference
derived

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

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