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Effects of Body Awareness Therapy in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Body Awareness Therapy
Home exercise program
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, body awareness therapy, pain, functional capacity

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary knee Osteoarthritis
  • Stage 2 -3 according to Kellgren - Lawrence Classification

Exclusion Criteria:

  • Previous surgery in the lower extremity
  • Neuromuscular disease
  • Vestibular pathology
  • Physiotherapy intervention or intra-articular injection within the last 6 months

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BAT+Home exercise program

Home exercise program

Arm Description

The patients in this group will participate in BAT for 3 days a week for 6 weeks in addition to home exercise program.

The patients in the control group will perform home exercise program, two times a day, 7 days a week for 6 weeks.

Outcomes

Primary Outcome Measures

Visual analog scale
change in knee pain intensity from baseline at 6 weeks,"0" point means that there is no pain, "10" point indicates severity of pain
Single leg stability
change in overall stability index of athlete single leg stability test in Biodex Balance System (BBS) from baseline at 6 weeks. Stability level of platform will be set as static. The results can be compared with normative values in the BBS. Lower scores indicate better stability and higher scores mean poor balance.
6 minute walk test
change in walking distance from baseline at 6 weeks
5 times sit to stand test
change in time needed to complete the test from baseline at 6 weeks
Stair climb test
change in time needed to complete the test form baseline at 6 weeks
Hand-held dynamometer
changes quadriceps muscle strength from baseline at 6 weeks

Secondary Outcome Measures

Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
change in scores from baseline at 6 weeks. Index consists of 24 items. In index maximum score is 96 points and minimum score is 0 point. Higher scores indicate worse symptoms, physical limitation.
Fall risk
change in overall stability index of fall risk test in Biodex Balance System from baseline at 6 weeks. Lower scores indicate better balance and high scores mean high risk for fall.
joint range of motion
change in knee joint range of motion from baseline at 6 weeks

Full Information

First Posted
November 13, 2019
Last Updated
June 29, 2020
Sponsor
Bezmialem Vakif University
Collaborators
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04165187
Brief Title
Effects of Body Awareness Therapy in Knee Osteoarthritis
Official Title
The Effects of Body Awareness Therapy on Pain, Balance and Functional Capacity in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
Collaborators
Medipol University

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 aim of this study is to investigate the effect of Body Awareness Therapy (BAT) on pain, balance and functional capacity in patients with knee osteoarthritis. Individuals will divided into two groups: training group and control group. Both groups will receive exercise training as a home program. Individuals in study group will participate in BAT training 3 days for 6 weeks. Assessments will be made before and after the 6-week study program.
Detailed Description
Symptoms such as pain, morning stiffness, and decreased muscle strength lead to a decrease in functional capacity and quality of life in knee osteoarthritis. It is estimated that 80% of patients with osteoarthritis have movement limitation and 25% are unable to perform significant daily activities. It is also stated that increases the risk of falls due to decrease proprioception in patients with knee osteoarthritis. In addition to physical symptoms, it is reported in the literature that symptoms such as sleep disturbance, depression and anxiety are seen and play a role in pain experience. It is stated in the literature that hypersensitivity of the central nervous system causes painful perception of normal body functions in chronic osteoarthritis, which leads patients to compensatory and dysfunctional movement strategies. Body Awareness Therapy (BAT) is a mind-body treatment approach directed towards awareness of body senses and how the body is used. The aim is to integrate the body and soul in the individual's experiences and to restructure body awareness and control. The aim of this study is to investigate the effect of BAT on pain, balance and functional capacity in patients with knee osteoarthritis. The study will consist of patients with stage 2-3 knee osteoarthritis according to Kellgren-Lawrence classification. The individuals included in the study will be divided into two groups as training and control groups using a computer-based randomization program. Both groups will be given a home program consisting of joint range of motion, stretching, strengthening and proprioceptive exercises. The control group will perform home exercise program and follow up will be made at once a week. The training group will participate in BAT for 3 days/week for 6 weeks in addition to home exercise program. Assessments will be made before and after the 6-week study program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, body awareness therapy, pain, functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAT+Home exercise program
Arm Type
Experimental
Arm Description
The patients in this group will participate in BAT for 3 days a week for 6 weeks in addition to home exercise program.
Arm Title
Home exercise program
Arm Type
Active Comparator
Arm Description
The patients in the control group will perform home exercise program, two times a day, 7 days a week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Body Awareness Therapy
Intervention Description
Body scanning, stretch-release movements, centralization, contact with the ground, postural stability, movement flow and free breathing will be performed during sessions in lying, sitting and standing positions.
Intervention Type
Other
Intervention Name(s)
Home exercise program
Intervention Description
Home exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity.
Primary Outcome Measure Information:
Title
Visual analog scale
Description
change in knee pain intensity from baseline at 6 weeks,"0" point means that there is no pain, "10" point indicates severity of pain
Time Frame
six weeks
Title
Single leg stability
Description
change in overall stability index of athlete single leg stability test in Biodex Balance System (BBS) from baseline at 6 weeks. Stability level of platform will be set as static. The results can be compared with normative values in the BBS. Lower scores indicate better stability and higher scores mean poor balance.
Time Frame
six weeks
Title
6 minute walk test
Description
change in walking distance from baseline at 6 weeks
Time Frame
six weeks
Title
5 times sit to stand test
Description
change in time needed to complete the test from baseline at 6 weeks
Time Frame
six weeks
Title
Stair climb test
Description
change in time needed to complete the test form baseline at 6 weeks
Time Frame
six weeks
Title
Hand-held dynamometer
Description
changes quadriceps muscle strength from baseline at 6 weeks
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
Description
change in scores from baseline at 6 weeks. Index consists of 24 items. In index maximum score is 96 points and minimum score is 0 point. Higher scores indicate worse symptoms, physical limitation.
Time Frame
six weeks
Title
Fall risk
Description
change in overall stability index of fall risk test in Biodex Balance System from baseline at 6 weeks. Lower scores indicate better balance and high scores mean high risk for fall.
Time Frame
six weeks
Title
joint range of motion
Description
change in knee joint range of motion from baseline at 6 weeks
Time Frame
six weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary knee Osteoarthritis Stage 2 -3 according to Kellgren - Lawrence Classification Exclusion Criteria: Previous surgery in the lower extremity Neuromuscular disease Vestibular pathology Physiotherapy intervention or intra-articular injection within the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kubra Alpay
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Eyup
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Body Awareness Therapy in Knee Osteoarthritis

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