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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04445350
Other study ID # StPoltenUAS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date April 30, 2022

Study information

Verified date June 2020
Source St. Pölten University of Applied Sciences
Contact Barbara Wondrasch, PhD
Phone +43/676/847 228 583
Email barbara.wondrasch@fhstp.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 30, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years to 60 Years
Eligibility 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 Design


Intervention

Other:
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.
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.

Locations

Country Name City State
Austria Sankt Pölten University of Applied Sciences Sankt Pölten Lower Austria

Sponsors (4)

Lead Sponsor Collaborator
St. Pölten University of Applied Sciences Danube University Krems, Karl Landsteiner University of Health Sciences, Orthopedic Hospital Speising

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee Adduction Moment (change over a period of 6 month with 3 measurement dates) 3D gait analysis during walking Baseline, 12 weeks, 24 weeks
Primary 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) Baseline, 6 weeks, 12 weeks, 24 weeks
Primary 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. Baseline, 6 weeks, 12 weeks, 24 weeks
Primary 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 Baseline, 6 weeks, 12 weeks, 24 weeks
Primary 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. Baseline, 6 weeks, 12 weeks, 24 weeks
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