Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-03-09 @ 4:29 AM
Study NCT ID:
NCT04154059
Status:
TERMINATED
Last Update Posted:
2025-04-02
First Post:
2019-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strengthening Program for Foot-ankle Muscles in People With Knee Osteoarthritis
Sponsor:
Universidade Federal de Sao Carlos
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The recruitment of potential participants is suspended due to the covid-19 pandemic.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: