NCT04445350

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

3.3 years

First QC Date

June 9, 2020

Last Update Submit

June 22, 2020

Conditions

Keywords

PhysiotherapyExternal Focus Of AttentionKnee Adduction MomentGait AnalysisOsteoarthritisMotor Learning

Outcome Measures

Primary Outcomes (5)

  • Knee Adduction Moment (change over a period of 6 month with 3 measurement dates)

    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)

    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)

    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)

    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)

    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

Study Arms (2)

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.

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.

Other: Internal Focus Of Attention

Interventions

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.

External focus of attention training program

In contrast, adopting an internal focus of attention (e.g. focus on specific body areal) can disrupt automatic control processes and interfere automatic movement.

Internal focus of attention training program

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Kellgren-Lawrence-Score 1-3
  • BMI \< 33
  • Free range of motion in the knee joint

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sankt Pölten University of Applied Sciences

Sankt Pölten, Lower Austria, 3100, Austria

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FH-Professor Barbara Wondrasch, PhD

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 24, 2020

Study Start

November 1, 2018

Primary Completion

February 28, 2022

Study Completion

April 30, 2022

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations