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Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03949400
Enrollment
40
Registered
2019-05-14
Start date
2018-04-24
Completion date
2029-05-20
Last updated
2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults, Knee Brace, Osteoarthritis, Knee, Outcome Assessment (Health Care), Pain, Patient Reported Outcome Measures, Recovery of Function, Rehabilitation, Treatment Outcome

Brief summary

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).

Detailed description

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.

Interventions

OTHERExercise therapy and education.

Exercise therapy and education, physiotherapy rehab at Aalborg Municipality

Sponsors

University College of Northern Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain - Numerical rating scale (NRS)6+12 weeks follow-upNRS 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

MeasureTime frameDescription
40-meter walk test6+12 weeks follow-upA test of walking speed over shirt distances and changing direction during walking
Y-balance test (YBT)6+12 weeks follow-upThe 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.
Self-perceived knee stability question6+12 weeks follow-upSelf-reported by the patients.

Other

MeasureTime frameDescription
Analgetic pain medication intake6+12 weeks follow-upSelf-reported by the patients.
Knee injury and Osteoarthritis Outcome Score (KOOS) (continous)6+12 weeks follow-upAn 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.
Pain manikin6+12 weeks follow upSelf-reported pain assessment by the patients.
Likert scale6+12 weeks follow-upSelf-reported by the patients

Countries

Denmark

Contacts

Primary ContactPalle S Jensen, Adjunct
plj@ucn.dk+4581719719
Backup ContactSteffan W Christensen, PhD
sec@ucn.dk+4572691009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026