- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04445350
Motor Learning in Knee Osteoarthritis (MLKOA)
June 22, 2020 updated by: Wondrasch, St. Pölten University of Applied Sciences
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Barbara Wondrasch, PhD
- Phone Number: +43/676/847 228 583
- Email: barbara.wondrasch@fhstp.ac.at
Study Locations
-
-
Lower Austria
-
Sankt Pölten, Lower Austria, Austria, 3100
- Recruiting
- Sankt Pölten University of Applied Sciences
-
Contact:
- Nicole Unger, Dr.
- Phone Number: +43/2742/313 228 246
- Email: nicole.unger@fhstp.ac.at
-
Contact:
- Birgit Bauer, Dr.
- Phone Number: +43/2742/313 228 371
- Email: birgit.bauer@fhstp.ac.at
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Kellgren-Lawrence-Score 1-3
- BMI < 33
- Free range of motion in the knee joint
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: External focus of attention training program
The intervention group receives a strength and neuromuscular training program.
The training instructions have an external focus of attention.
|
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.
|
Active Comparator: Internal focus of attention training program
The control group receives a strength and neuromuscular training program.
The training instructions have an internal focus of attention.
|
In contrast, adopting an internal focus of attention (e.g.
focus on specific body areal) can disrupt automatic control processes and interfere automatic movement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 12 weeks, 24 weeks
|
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)
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
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.
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
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
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
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.
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Anticipated)
February 28, 2022
Study Completion (Anticipated)
April 30, 2022
Study Registration Dates
First Submitted
June 9, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (Actual)
June 24, 2020
Study Record Updates
Last Update Posted (Actual)
June 24, 2020
Last Update Submitted That Met QC Criteria
June 22, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- StPoltenUAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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