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NCT Number: NCT03949400

Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

The primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (OA).

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Key information

Conditions

Rehabilitation Adults Arthritis Joint Diseases Knee Brace Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Outcome Assessment (Health Care) Pain Pathological Conditions, Signs and Symptoms Patient Reported Outcome Measures Recovery of Function Rheumatic Diseases Signs and Symptoms Treatment Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg Municipality, training unit west

Aalborg, Nothern, 9000, Denmark

Location status: Recruiting

Location contact

Ina Lesager

CONTACT

+4531990452

About this study

Study type: observational Estimated enrollment: 40 participants Observational model: cohort Time perspective: prospective

Inclusion criteria

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion criteria

Not mentally able to reply to the questionnaire

Patients are tested with and without the brace before starting the exercise therapy and education program and re-tested with and without the brace after completing the treatment program (6 weeks) and again at 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion criteria

Not mentally able to reply to the questionnaire

Treatment and study plan

Exercise therapy and education.

Other

Exercise therapy and education, physiotherapy rehab at Aalborg Municipality

Primary outcomes

  1. Pain - Numerical rating scale (NRS)

    Time frame: 6+12 weeks follow-up

    NRS is the most common pain scale for quantification pain. The respondent selects a whole number on a scale from 0-10, that best reflects the intensity of his/her pain. 0 being no pain, 10 being the worst pain imaginable.

Secondary outcomes

  1. Y-balance test (YBT)

    Time frame: 6+12 weeks follow-up

    The YBT test is a test commonly used in clinical practice to investigate functional balance. The YBT is based on the Star Excursion Balance Test and it has been thoroughly researched. Measured with and without the soft knee brace at baseline, after the treatment program and at 12weeks.

  2. Self-perceived knee stability question

    Time frame: 6+12 weeks follow-up

    Self-reported by the patients.

  3. 40-meter walk test

    Time frame: 6+12 weeks follow-up

    A test of walking speed over shirt distances and changing direction during walking

Other outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS) (continous)

    Time frame: 6+12 weeks follow-up

    An instrument to assess the patient's opinion about their knee and associated problems. KOOS has been evaluated and compared to other instruments in several studies. Measured at baseline, after the treatment program and at 12weeks.

  2. Pain manikin

    Time frame: 6+12 weeks follow up

    Self-reported pain assessment by the patients.

  3. Likert scale

    Time frame: 6+12 weeks follow-up

    Self-reported by the patients

  4. Analgetic pain medication intake

    Time frame: 6+12 weeks follow-up

    Self-reported by the patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Palle S Jensen, Adjunct

CONTACT

[email protected]

+4581719719

Steffan W Christensen, PhD

CONTACT

[email protected]

+4572691009

Sponsors and collaborators

Lead sponsor

University College of Northern Denmark

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2029
First posted
May 14, 2019
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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