Motor Learning in Knee Osteoarthritis (MLKOA)
Primary Purpose
Knee Osteoarthritis, Lower Extremity Biomechanics, Physiotherapy
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
External Focus Of Attention
Internal Focus Of Attention
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Physiotherapy, External Focus Of Attention, Knee Adduction Moment, Gait Analysis, Osteoarthritis, Motor Learning
Eligibility Criteria
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
Sites / Locations
- Sankt Pölten University of Applied SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
External focus of attention training program
Internal focus of attention training program
Arm Description
The intervention group receives a strength and neuromuscular training program. The training instructions have an external focus of attention.
The control group receives a strength and neuromuscular training program. The training instructions have an internal focus of attention.
Outcomes
Primary Outcome Measures
Knee Adduction Moment (change over a period of 6 month with 3 measurement dates)
3D gait analysis during walking
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)
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.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04445350
First Posted
June 9, 2020
Last Updated
June 22, 2020
Sponsor
St. Pölten University of Applied Sciences
Collaborators
Danube University Krems, Karl Landsteiner University of Health Sciences, Orthopedic Hospital Speising
1. Study Identification
Unique Protocol Identification Number
NCT04445350
Brief Title
Motor Learning in Knee Osteoarthritis
Acronym
MLKOA
Official Title
Motor Learning in Knee Osteoarthritis Therapy - A New Rehabilitation Approach
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Pölten University of Applied Sciences
Collaborators
Danube University Krems, Karl Landsteiner University of Health Sciences, Orthopedic Hospital Speising
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Lower Extremity Biomechanics, Physiotherapy
Keywords
Physiotherapy, External Focus Of Attention, Knee Adduction Moment, Gait Analysis, Osteoarthritis, Motor Learning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
External focus of attention training program
Arm Type
Experimental
Arm Description
The intervention group receives a strength and neuromuscular training program. The training instructions have an external focus of attention.
Arm Title
Internal focus of attention training program
Arm Type
Active Comparator
Arm Description
The control group receives a strength and neuromuscular training program. The training instructions have an internal focus of attention.
Intervention Type
Other
Intervention Name(s)
External Focus Of Attention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Internal Focus Of Attention
Intervention Description
In contrast, adopting an internal focus of attention (e.g. focus on specific body areal) can disrupt automatic control processes and interfere automatic movement.
Primary Outcome Measure Information:
Title
Knee Adduction Moment (change over a period of 6 month with 3 measurement dates)
Description
3D gait analysis during walking
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Knee Osteoarthritis Outcome Score (change over a period of 6 month with 4 measurement dates)
Description
Questionnaire; Minimum value: 0 (highest limitation), Maximum: 100 (no limitation)
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Star Excursion Balance Test (change over a period of 6 month with 4 measurement dates)
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Isometric strength tests (change over a period of 6 month with 4 measurement dates)
Description
Measures the isometric force of the knee extensors, knee flexors, hip abductors, hip extensors and hip external rotators with a portable dynamometer
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Six minute walking test (change over a period of 6 month with 4 measurement dates)
Description
The six minute walking test is a reliable measuring tool to examine the distance a person can walk in a given time period.
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Wondrasch, PhD
Phone
+43/676/847 228 583
Email
barbara.wondrasch@fhstp.ac.at
Facility Information:
Facility Name
Sankt Pölten University of Applied Sciences
City
Sankt Pölten
State/Province
Lower Austria
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Unger, Dr.
Phone
+43/2742/313 228 246
Email
nicole.unger@fhstp.ac.at
First Name & Middle Initial & Last Name & Degree
Birgit Bauer, Dr.
Phone
+43/2742/313 228 371
Email
birgit.bauer@fhstp.ac.at
12. IPD Sharing Statement
Learn more about this trial
Motor Learning in Knee Osteoarthritis
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