Knee OsteoarthritisMLKOANCT04445350
Motor Learning in Knee Osteoarthritis
A study testing External Focus Of Attention and Internal Focus Of Attention in people with Knee Osteoarthritis and Lower Extremity Biomechanics, run by St. Pölten University of Applied Sciences at 1 site in Austria.
Trial summary
Non-surgical treatment options, like exercise therapy, show excellent short-term effects regarding pain reduction and improvement of knee function. However, mid- and long-term effects are missing so far. This might indicate that long-lasting changes in motor-skill performance (Motor Learning) have not occurred. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Knee Osteoarthritis, Lower Extremity Biomechanics, Physiotherapy
- What is being tested?
- External Focus Of Attention and Internal Focus Of Attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2018to 30 Apr 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Kellgren-Lawrence-Score 1-3
- BMI < 33
- Free range of motion in the knee joint
Who cannot join
- Activated knee osteoarthritis
- Lower extremity surgery in the past 6 weeks
- Intake or injection of corticosteroids in the past 3 month
- Long-term medication non-steroidal anti-inflammatory drugs
- Neurological diseases
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Sankt Pölten University of Applied Sciences
Sankt Pölten, Lower Austria, 3100
Nicole Unger, Dr., +43/2742/313 228 246, nicole.unger@fhstp.ac.at
Birgit Bauer, Dr., +43/2742/313 228 371, birgit.bauer@fhstp.ac.at
About this study
Official title: Motor Learning in Knee Osteoarthritis Therapy - A New Rehabilitation Approach
Non-surgical treatment options, like exercise therapy, show excellent short-term effects regarding pain reduction and improvement of knee function. However, mid- and long-term effects are missing so far. This might indicate that long-lasting changes in motor-skill performance (Motor Learning) have not occurred. Motor learning is associated with permanent changes in the capability for skilled movement behavior avoiding unfavorable joint loads and inappropriate muscle activation patterns, leading to compensatory movement strategies. One-sided and high repetitive loads in the knee joint could be one reason for the progression of knee osteoarthritis. Physiotherapeutic strategies should therefore be able to stimulate motor learning processes. In physiotherapy, motor learning can be optimized by using instructions and feedback, targeting an external focus of attention, when learning specific movement patterns. This study investigates the effects of a 12 week exercise therapy program, using an external focus of attention, on functional and biomechanical parameters in patients with knee osteoarthritis. To measure possible changes, functional measurements are taking place at baseline, after 6, 12 and 24 weeks. The biomechanical measurements (3D gait analysis) are taking place at baseline, after 12 and 24 weeks.
- Being tested
- External Focus Of Attention, Internal Focus Of Attention
- Keywords
- Physiotherapy, External Focus Of Attention, Knee Adduction Moment, Gait Analysis, Osteoarthritis, Motor Learning
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Focus Of AttentionOther
Instructions and feedback are used to direct the learner's focus to an external source (e.g. the effect the intended movement has) promoting long-term learning by stimulating automatic cognitive control processes.
Internal Focus Of AttentionOther
In contrast, adopting an internal focus of attention (e.g. focus on specific body areal) can disrupt automatic control processes and interfere automatic movement.
| Study group | Role | What they receive |
|---|---|---|
| External focus of attention training program | Experimental | The intervention group receives a strength and neuromuscular training program. The training instructions have an external focus of attention. Receives: Other: External Focus Of Attention |
| Internal focus of attention training program | Active comparator | The control group receives a strength and neuromuscular training program. The training instructions have an internal focus of attention. Receives: Other: Internal Focus Of Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Adduction Moment (change over a period of 6 month with 3 measurement dates)
3D gait analysis during walking
Measured: Baseline, 12 weeks, 24 weeks
Knee Osteoarthritis Outcome Score (change over a period of 6 month with 4 measurement dates)
Questionnaire; Minimum value: 0 (highest limitation), Maximum: 100 (no limitation)
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Star Excursion Balance Test (change over a period of 6 month with 4 measurement dates)
An established test to determine movement control and balance ability. The test person stands on one leg and will is asked to stretch the non supporting leg as far as possible in the directions presented.
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Isometric strength tests (change over a period of 6 month with 4 measurement dates)
Measures the isometric force of the knee extensors, knee flexors, hip abductors, hip extensors and hip external rotators with a portable dynamometer
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Six minute walking test (change over a period of 6 month with 4 measurement dates)
The six minute walking test is a reliable measuring tool to examine the distance a person can walk in a given time period.
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Nov 2018
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Pölten University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Danube University Krems, Karl Landsteiner University of Health Sciences, Orthopedic Hospital Speising
- Responsible party
- Principal investigator, Wondrasch, St. Pölten University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445350
- Sponsor's protocol ID
- StPoltenUAS
- Acronym
- MLKOA
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning in Knee Osteoarthritis Therapy - A New Rehabilitation Approach
- ClinicalTrials.gov ID
- NCT04445350
- Acronym / sponsor ID
- MLKOA / StPoltenUAS
- Keywords
- Physiotherapy, External Focus Of Attention, Knee Adduction Moment, Gait Analysis, Osteoarthritis, Motor Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Pölten University of Applied SciencesUniversity, hospital or other
- Collaborators
- Danube University Krems, Karl Landsteiner University of Health Sciences, Orthopedic Hospital Speising
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 24 Jun 2020 (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.
Non-surgical treatment options, like exercise therapy, show excellent short-term effects regarding pain reduction and improvement of knee function. However, mid- and long-term effects are missing so far. This might indicate that long-lasting changes in motor-skill performance (Motor Learning) have not occurred. Motor learning is associated with permanent changes in the capability for skilled movement behavior avoiding unfavorable joint loads and inappropriate muscle activation patterns, leading to compensatory movement strategies. One-sided and high repetitive loads in the knee joint could be one reason for the progression of knee osteoarthritis. Physiotherapeutic strategies should therefore be able to stimulate motor learning processes. In physiotherapy, motor learning can be optimized by using instructions and feedback, targeting an external focus of attention, when learning specific movement patterns. This study investigates the effects of a 12 week exercise therapy program, using an external focus of attention, on functional and biomechanical parameters in patients with knee osteoarthritis. To measure possible changes, functional measurements are taking place at baseline, after 6, 12 and 24 weeks. The biomechanical measurements (3D gait analysis) are taking place at baseline, after 12 and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External focus of attention training program | Experimental | Other: External Focus Of AttentionThe intervention group receives a strength and neuromuscular training program. The training instructions have an external focus of attention. |
| Internal focus of attention training program | Active comparator | Other: Internal Focus Of AttentionThe control group receives a strength and neuromuscular training program. The training instructions have an internal focus of attention. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Kellgren-Lawrence-Score 1-3
- BMI < 33
- Free range of motion in the knee joint
Key exclusion criteria (6 listed)
- Activated knee osteoarthritis
- Lower extremity surgery in the past 6 weeks
- Intake or injection of corticosteroids in the past 3 month
- Long-term medication non-steroidal anti-inflammatory drugs
- Neurological diseases
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 |
|---|---|---|
| External Focus Of AttentionInstructions and feedback are used to direct the learner's focus to an external source (e.g. the effect the intended movement has) promoting long-term learning by stimulating automatic cognitive control processes. | Other | External focus of attention training program |
| Internal Focus Of AttentionIn contrast, adopting an internal focus of attention (e.g. focus on specific body areal) can disrupt automatic control processes and interfere automatic movement. | Other | Internal focus of attention training program |
Primary outcome
Knee Adduction Moment (change over a period of 6 month with 3 measurement dates)
Time frame: Baseline, 12 weeks, 24 weeks
3D gait analysis during walking
Knee Osteoarthritis Outcome Score (change over a period of 6 month with 4 measurement dates)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Questionnaire; Minimum value: 0 (highest limitation), Maximum: 100 (no limitation)
Star Excursion Balance Test (change over a period of 6 month with 4 measurement dates)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
An established test to determine movement control and balance ability. The test person stands on one leg and will is asked to stretch the non supporting leg as far as possible in the directions presented.
Isometric strength tests (change over a period of 6 month with 4 measurement dates)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Measures the isometric force of the knee extensors, knee flexors, hip abductors, hip extensors and hip external rotators with a portable dynamometer
Six minute walking test (change over a period of 6 month with 4 measurement dates)
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
The six minute walking test is a reliable measuring tool to examine the distance a person can walk in a given time period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Focus Of Attention and Internal Focus Of Attention in people with Knee Osteoarthritis and Lower Extremity Biomechanics, run by St. Pölten University of Applied Sciences at 1 site in Austria.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jun 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Wondrasch, PhD (+43/676/847 228 583, barbara.wondrasch@fhstp.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Adduction Moment (change over a period of 6 month with 3 measurement dates) (time frame: Baseline, 12 weeks, 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2020.