RehabilitationNCT03949400
Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis
An observational study of Rehabilitation and Treatment Outcome, run by University College of Northern Denmark at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Treatment Outcome, Pain
- What is being tested?
- Exercise therapy and education.
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Apr 2018to 20 May 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with knee OA and assigned to undergo exercise therapy and education
Who may be able to join
- 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
Who cannot join
- Not mentally able to reply to the questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg Municipality, training unit west
Aalborg, Nothern, 9000
Ina Lesager, +4531990452
About this study
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).
Read the 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.
- Conditions
- Rehabilitation, Treatment Outcome, Pain, Knee Brace, Outcome Assessment (Health Care), Recovery of Function
- Being tested
- Exercise therapy and education.
- Medical subject headings
- Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapy and education.Other
Exercise therapy and education, physiotherapy rehab at Aalborg Municipality
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with knee OA | Patients diagnosed with knee OA and assigned to undergo exercise therapy and education. Receives: Other: Exercise therapy and education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6+12 weeks follow-up
Secondary outcomes (3)
Y-balance test (YBT)
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.
Measured: 6+12 weeks follow-up
Self-perceived knee stability question
Self-reported by the patients.
Measured: 6+12 weeks follow-up
40-meter walk test
A test of walking speed over shirt distances and changing direction during walking
Measured: 6+12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start24 Apr 2018
- Primary completion24 Apr 2020 (estimated)
- Study completion20 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorte Drachmann, Study director, Department of Physiotherapy, University College of Northern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949400
- Sponsor's protocol ID
- FOU-UU-2018-007
- Status last verified
- Feb 2019
- First submitted
- 2 Oct 2018
- Last updated
- 14 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided