Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

Sponsor
University College of Northern Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT03949400
Collaborator
(none)
40
1
132.9
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Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis
Actual Study Start Date :
Apr 24, 2018
Anticipated Primary Completion Date :
Apr 24, 2020
Anticipated Study Completion Date :
May 20, 2029

Arms and Interventions

Arm Intervention/Treatment
Patients diagnosed with knee OA

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

Other: Exercise therapy and education.
Exercise therapy and education, physiotherapy rehab at Aalborg Municipality

Outcome Measures

Primary Outcome Measures

  1. Pain - Numerical rating scale (NRS) [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 Outcome Measures

  1. Y-balance test (YBT) [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 [6+12 weeks follow-up]

    Self-reported by the patients.

  3. 40-meter walk test [6+12 weeks follow-up]

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

Other Outcome Measures

  1. Knee injury and Osteoarthritis Outcome Score (KOOS) (continous) [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 [6+12 weeks follow up]

    Self-reported pain assessment by the patients.

  3. Likert scale [6+12 weeks follow-up]

    Self-reported by the patients

  4. Analgetic pain medication intake [6+12 weeks follow-up]

    Self-reported by the patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aalborg Municipality, training unit west Aalborg Nothern Denmark 9000

Sponsors and Collaborators

  • University College of Northern Denmark

Investigators

  • Study Director: Dorte Drachmann, Department of Physiotherapy, University College of Northern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College of Northern Denmark
ClinicalTrials.gov Identifier:
NCT03949400
Other Study ID Numbers:
  • FOU-UU-2018-007
First Posted:
May 14, 2019
Last Update Posted:
May 14, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 14, 2019