Knee OsteoarthritisNCT04165187
Effects of Body Awareness Therapy in Knee Osteoarthritis
A study testing Body Awareness Therapy and Home exercise program in people with Knee Osteoarthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Body Awareness Therapy and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary knee Osteoarthritis
- Stage 2 -3 according to Kellgren - Lawrence Classification
Who cannot join
- Previous surgery in the lower extremity
- Neuromuscular disease
- Vestibular pathology
- Physiotherapy intervention or intra-articular injection within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Body Awareness Therapy on Pain, Balance and Functional Capacity in Patients With Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Body Awareness Therapy, Home exercise program
- Keywords
- knee osteoarthritis, body awareness therapy, pain, functional capacity
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Awareness TherapyOther
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.
Home exercise programOther
Home exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity.
| Study group | Role | What they receive |
|---|---|---|
| BAT+Home exercise program | Experimental | The patients in this group will participate in BAT for 3 days a week for 6 weeks in addition to home exercise program. Receives: Other: Body Awareness Therapy; Other: Home exercise program |
| Home exercise program | Active comparator | The patients in the control group will perform home exercise program, two times a day, 7 days a week for 6 weeks. Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six weeks
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.
Measured: six weeks
6 minute walk test
change in walking distance from baseline at 6 weeks
Measured: six weeks
5 times sit to stand test
change in time needed to complete the test from baseline at 6 weeks
Measured: six weeks
Stair climb test
change in time needed to complete the test form baseline at 6 weeks
Measured: six weeks
Hand-held dynamometer
changes quadriceps muscle strength from baseline at 6 weeks
Measured: six weeks
Secondary outcomes (3)
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.
Measured: six weeks
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.
Measured: six weeks
joint range of motion
change in knee joint range of motion from baseline at 6 weeks
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Jan 2020
- Primary completion30 May 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Kübra Alpay, Bezmialem Vakif University
- Investigators
- Kubra Alpay, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165187
- Sponsor's protocol ID
- Kubra1
- Status last verified
- Jun 2020
- First submitted
- 13 Nov 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alpay K, Sahin M. Effects of basic body awareness therapy on pain, balance, muscle strength and functionality in knee osteoarthritis: a randomised preliminary trial. Disabil Rehabil. 2023 Dec;45(26):4373-4380. doi: 10.1080/09638288.2022.2151650. Epub 2022 Nov 29.
PubMed 36444879
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Body Awareness Therapy on Pain, Balance and Functional Capacity in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04165187
- Acronym / sponsor ID
- Kubra1
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, body awareness therapy, pain, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAT+Home exercise program | Experimental | Other: Body Awareness Therapy, Other: Home exercise programThe patients in this group will participate in BAT for 3 days a week for 6 weeks in addition to home exercise program. |
| Home exercise program | Active comparator | Other: Home exercise programThe patients in the control group will perform home exercise program, two times a day, 7 days a week for 6 weeks. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary knee Osteoarthritis
- Stage 2 -3 according to Kellgren - Lawrence Classification
Key exclusion criteria (4 listed)
- Previous surgery in the lower extremity
- Neuromuscular disease
- Vestibular pathology
- Physiotherapy intervention or intra-articular injection within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Awareness TherapyBody 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. | Other | BAT+Home exercise program |
| Home exercise programHome exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity. | Other | BAT+Home exercise program, Home exercise program |
Primary outcome
Visual analog scale
Time frame: six weeks
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
Time frame: six weeks
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
Time frame: six weeks
change in walking distance from baseline at 6 weeks
5 times sit to stand test
Time frame: six weeks
change in time needed to complete the test from baseline at 6 weeks
Stair climb test
Time frame: six weeks
change in time needed to complete the test form baseline at 6 weeks
Hand-held dynamometer
Time frame: six weeks
changes quadriceps muscle strength from baseline at 6 weeks
3 secondary outcomes
Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
Time frame: six weeks
Fall risk
Time frame: six weeks
joint range of motion
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Derived from this study: PubMed 36444879Alpay K, Sahin M. Effects of basic body awareness therapy on pain, balance, muscle strength and functionality in knee osteoarthritis: a randomised preliminary trial. Disabil Rehabil. 2023 Dec;45(26):4373-4380. doi: 10.1080/09638288.2022.2151650. Epub 2022 Nov 29.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kubra Alpay principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Awareness Therapy and Home exercise program in people with Knee Osteoarthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: six weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04165187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.