Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-27 @ 2:58 PM
Study NCT ID:
NCT01342458
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2011-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Therapeutic Effect of Inexpensive, Flexible and Non-heeled Footwear on the Clinical, Functional and Gait Biomechanics in Elderly Women With Knee Osteoarthritis: a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OA
Brief Summary:
The purpose of this study is to determine whether inexpensive, flexible and non-heeled footwear is effective in improving of clinical, functional and gait biomechanics in elderly women with knee osteoarthritis.
Detailed Description:
* The clinical and functional aspects will be evaluated using a visual analogue scale (VAS) for pain, Western Ontario and McMaster Universities (WOMAC) and Lequesne questionnaires of quality of life in patients with knee osteoarthritis and testing of six-minute walk (6MWT).
* Biomechanical analysis of gait will be performed by infrared cameras and a force platform. From the data of kinematics and kinetics, will be calculated moments of the knee joint strength by inverse dynamics.
The process (steps) will be divided as follows:
* step 1, in this step there will be sorting and initial assessment of potential participants; pain will be evaluated through VAS, function and quality of life by means of questionnaires WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of gait.
* step 2,(3 month follow-up), both groups will be evaluated again by the VAS and WOMAC and Lequesne questionnaires.
* step 3, after 6 months of starting the monitoring process, both groups will be reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of gait. This step is the final evaluation, characterizing the end of intervention.
* Biomechanical analysis of gait will be performed by infrared cameras and a force platform. From the data of kinematics and kinetics, will be calculated moments of the knee joint strength by inverse dynamics.
The process (steps) will be divided as follows:
* step 1, in this step there will be sorting and initial assessment of potential participants; pain will be evaluated through VAS, function and quality of life by means of questionnaires WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of gait.
* step 2,(3 month follow-up), both groups will be evaluated again by the VAS and WOMAC and Lequesne questionnaires.
* step 3, after 6 months of starting the monitoring process, both groups will be reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of gait. This step is the final evaluation, characterizing the end of intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: