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Assessment of a Knee Brace in Patients With Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Knee brace
Sponsored by
Irmandade da Santa Casa de Misericordia de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • individuals of both sexes
  • aged 40 -60
  • at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology,
  • pain above four points in the visual analogue scale (VAS)
  • diagnosed with knee osteoarthritis
  • no physical therapy treatment prior

Exclusion Criteria:

  • neurological impairment
  • partial or total knee prosthesis
  • cardio-respiratory diseases
  • pregnant women
  • individuals who failed to perform the tests proposed

Sites / Locations

  • Irmandade da Santa Casa de Misericórdia de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Knee brace with a hole

Knee brace without a hole

Arm Description

Patients will be prepared to receive the device of knee brace with a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.

Patients will be prepared to receive the device of knee brace without a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.

Outcomes

Primary Outcome Measures

Change on pain sensation
Change on pain sensation will be compared from the baseline (before wearing the brace knee) with the pain sensation right after or maximum five minutes after wearing the brace knee. This evaluation will be performed asking the patient to identify their pain sensation by the visual analogue scale (VAS).

Secondary Outcome Measures

Change on leg function
Change on leg function will be measured before wearing the knee brace (baseline) and compared with right after or maximum five minutes after wearing the knee brace evaluation. Leg function will be assessed by Time Up and Go (TUG) test.
Change on agility
Change on agility will be measured before wearing the knee brace (baseline) and compared to right after or maximum five minutes after wearing the brace knee evaluation. Agility will be assessed by 8 Meter Walk test. The time to complete this test will be recorded by the researchers and this time will be the result considered for comparison from baseline and after wearing the knee brace.

Full Information

First Posted
November 28, 2015
Last Updated
March 7, 2016
Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02706106
Brief Title
Assessment of a Knee Brace in Patients With Osteoarthritis
Official Title
Assessment of a Knee Brace in Patients With Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is a controlled clinical trial randomized, double-blind evaluator. Will be considered eligible patients, individuals of both sexes, aged 40 -60, to submit at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology, pain above four points in the visual analogue scale (VAS), diagnosed with knee osteoarthritis and who sought physical therapy treatment. Patients will be randomized by a number sequence generated by a computer using Microsoft Excel (Microsoft Corporation, Redmond, Washington), in opaque envelopes by researcher who will not attend the study.Patients will be divided into two groups: group with knee patellar hole or group without knee patellar hole. Shortly after the selection of the knee, the patient will have his eyes blind or cover in order to keep it '' blind '' regarding the type of knee brace that it would use. Finally evaluator 1 will cover the knee with a black cloak, making the second evaluator ''blind '' regarding the type of knee brace that will be used. Two investigators will carry out the data collection. The first evaluator will collect information on the clinical characteristics of patients, including evaluation form, numerical pain scale, which measures the intensity of pain, test Time Up and Go (TUG) test that measures the basic mobility of movement and test walking eight meters, whose purpose is to measure the time that the individual takes to walk a distance of eight meters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee brace with a hole
Arm Type
Experimental
Arm Description
Patients will be prepared to receive the device of knee brace with a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.
Arm Title
Knee brace without a hole
Arm Type
Placebo Comparator
Arm Description
Patients will be prepared to receive the device of knee brace without a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.
Intervention Type
Device
Intervention Name(s)
Knee brace
Intervention Description
Patients will be prepared to receive the device of knee brace with or without a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.
Primary Outcome Measure Information:
Title
Change on pain sensation
Description
Change on pain sensation will be compared from the baseline (before wearing the brace knee) with the pain sensation right after or maximum five minutes after wearing the brace knee. This evaluation will be performed asking the patient to identify their pain sensation by the visual analogue scale (VAS).
Time Frame
Pain will be measured before and right after or maximum five minutes after wearing the brace knee
Secondary Outcome Measure Information:
Title
Change on leg function
Description
Change on leg function will be measured before wearing the knee brace (baseline) and compared with right after or maximum five minutes after wearing the knee brace evaluation. Leg function will be assessed by Time Up and Go (TUG) test.
Time Frame
Leg function will be measured before and right after or maximum five minutes after wearing the brace knee
Title
Change on agility
Description
Change on agility will be measured before wearing the knee brace (baseline) and compared to right after or maximum five minutes after wearing the brace knee evaluation. Agility will be assessed by 8 Meter Walk test. The time to complete this test will be recorded by the researchers and this time will be the result considered for comparison from baseline and after wearing the knee brace.
Time Frame
Agility will be measured before and right after or maximum five minutes after wearing the brace knee

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: individuals of both sexes aged 40 -60 at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology, pain above four points in the visual analogue scale (VAS) diagnosed with knee osteoarthritis no physical therapy treatment prior Exclusion Criteria: neurological impairment partial or total knee prosthesis cardio-respiratory diseases pregnant women individuals who failed to perform the tests proposed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco N Added, MSc
Organizational Affiliation
Irmandade da Santa Casa de Misericórdia de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Assessment of a Knee Brace in Patients With Osteoarthritis

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