Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

NCT03949400 | Recruiting

• 1 other identifier: FOU-UU-2018-007
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pain - Numerical rating scale (NRS)

  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.

  6+12 weeks follow-up

Secondary Outcomes (3)

• Y-balance test (YBT)

  6+12 weeks follow-up

• Self-perceived knee stability question

  6+12 weeks follow-up

• 40-meter walk test

  6+12 weeks follow-up

Other Outcomes (4)

• Knee injury and Osteoarthritis Outcome Score (KOOS) (continous)

  6+12 weeks follow-up

• Pain manikin

  6+12 weeks follow up

• Likert scale

  6+12 weeks follow-up

Study Arms (1)

Patients diagnosed with knee OA

Patients diagnosed with knee OA and assigned to undergo exercise therapy and education.

Other: Exercise therapy and education.

Interventions

Exercise therapy and education. OTHER

Exercise therapy and education, physiotherapy rehab at Aalborg Municipality

Patients diagnosed with knee OA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with knee OA and assigned to undergo exercise therapy and education

You may qualify if:

• 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

You may not qualify if:

• Not mentally able to reply to the questionnaire

Sponsors & Collaborators

• University College of Northern Denmark: lead

Study Sites (1)

Aalborg Municipality, training unit west

Aalborg, Nothern, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee

Interventions

Exercise Therapy; Educational Status

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Socioeconomic Factors; Population Characteristics

Study Officials

• Dorte Drachmann

  Department of Physiotherapy, University College of Northern Denmark

  STUDY DIRECTOR

Central Study Contacts

Palle S Jensen, Adjunct

CONTACT

+4581719719; plj@ucn.dk

Steffan W Christensen, PhD

CONTACT

+4572691009; sec@ucn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: May 14, 2019
• Study Start: April 24, 2018
• Primary Completion: April 24, 2020
• Study Completion (Estimated): May 20, 2029
• Last Updated: May 14, 2019

Record last verified: 2019-02

Locations

DK (1)