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van CCT (UK)

van CCT (UK)

Effects of a knee soft brace in patients with knee osteoarthritis.

- candidate number27213
- NTR NumberNTR6363
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mei-2017
- Secondary IDs2015.15 NL51872.029.15 
- Public TitleEffects of a knee soft brace in patients with knee osteoarthritis.
- Scientific TitleEffect of a soft brace on knee pain, knee stability and activity limitations in patients with knee osteoarthritis (OA).
- hypothesisA soft brace will improve pain, knee instability and activity limitations in the study participants with knee ostoearthritis.
- Healt Condition(s) or Problem(s) studiedKnee osteoarthritis
- Inclusion criteriaPatients from the Amsterdam Osteoarthritis cohort with a unilateral or bilateral diagnosis of knee OA according to the American College of Rheumatology (ACR) will be included. ACR criteria are age over 50 years, morning stiffness less than 30 minutes, crepitus on active motion, bony tenderness, or absence of palpable warmth of synovium. Inclusion criteria for the current study are knee osteoarthritis based on the ACR criteria, age between the 50 and 80 years old, Body Mass Index (BMI) between 20 and 30 kg/m2, a maximal score of 7 on the numeric rate scale (NRS) for pain intensity during the past two weeks and having the perception of an episode of buckling, shifting or giving way of the knee in the past three months.
- Exclusion criteriaTotal knee replacement, rheumatoid arthritis or any other form of inflammatory arthritis (i.e., crystal arthropathy or septic arthritis).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2015
- planned closingdate31-jan-2018
- Target number of participants36
- InterventionsA knee soft brace (knee sleeve)
- Primary outcomePain assessed with Numeric Rating Scale (NRS)
- Secondary outcomeActivity limitations (Get Up and Go Test and 10-m walk test);
Self-reported knee instability;
Self-reported knee confidence
- TimepointsImmediate effects: Single session lab experimental study
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
European Union
- PublicationsThe effect of a soft brace on pain and physcial function in knee osteoarthritis: systematic review and meta-analyses. Accepted for publication in Archives of Physcial Medicine and Rehabilitation.
- Brief summaryA within-subject longitudinal design, comparing no soft brace versus soft brace, and comparing two types of soft braces: tight versus non-tight. The order of application of tight and non-tight soft braces will be randomized. Directly before, during and directly after walking on a treadmill assessments will be performed. Patient and clinical characteristics will be assessed at the begin of the measurements including demographics, self-reported activity limitations (WOMAC-questionnaire), NRS pain during the last week, knee instability during the last three months, muscle strength and radiographic severity (K&L grade). Before walking on the treadmill, knee proprioception, skin sensitivity, pressure pain, postural balance and performed based activity limitations (GUG and 10-m walk test) will be assessed. During walking on the treadmill without wearing a knee brace, pain and knee stability will be assessed. During walking with the application of a soft brace, kinematic data will be assessed for objectifying knee stability. Directly after walking on the treadmill the measurement of proprioception, skin sensitivity, pain, pressure pain, knee stability, postural balance and performance based activity limitations (GUG and 10-m walk test) will be repeated. The assessment in the second trial with another brace, is identical to the assessment in the first trial.
- Main changes (audit trail)
- RECORD15-mei-2017 - 16-jun-2017

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