The added effect of knee orthosis with home-based exercise (tele-rehabilitation) on pain, physical function and thickness of the quadriceps muscle in patients with mild to moderate degrees of knee osteoarthritis

The added effect of knee orthosis with home exercise (tele-rehabilitation) on pain, physical function and thickness of the quadriceps muscle in patients with knee osteoarthritis

Parallel group, Randomized controlled trial with outcome assessor blinded

All the assessments, interventions, and data collection steps will be carried out at the School of rehabilitation, iran university of medical science. The outcome assessor and statistician will be blinded.

aged 50-65 years old, Kellgren and Lawrence grade 2 or 3 according to AP knee radiographs, pain intensity at least 4 based on Visual Analog Scale (VAS), standing and walking without assistance

two groups: home exercise and home exercise with knee orthosis

Primary variables: pain via Visual Analog Scale (VAS), physical function via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire Secondary variables: quadriceps muscle thickness, functional mobility via Timed Up and GO (TUG) test, lower limb function via 30 sit-stand test, Kinesiophobia

The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 44, however, to take account of potential withdrawals, 50 patients (n=25 per group) will be recruited for the study. First, create and seal 25 treatment A envelopes, and 25 treatment B envelopes. To create a block of 6, we will select 3 treatment A envelopes, and 3 treatment B envelopes. These 6 envelopes will be shuffled thoroughly, and place this block of 6 in a separate pile. To create a block of 4, we will select 2 treatment A envelops, and 2 treatment B envelopes. Then, we will prepare additional blocks of 6 and 4 until all 25 treatment A, and B envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 3 individuals piles of shuffled blocks of 6, and 8 individuals piles of shuffled blocks of 4.

The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis and the patients will remove their orthosis before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician.

Our research findings will be shared with all researchers, and practitioners. We will publish our research findings in scientific journals

All documents can be shared 1 year after article publication

Researchers and health practitioners

Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.

Fatemeh Azadinia

Send email to corresponding author.