The Effectiveness of a blended care Tele-rehabilitation Versus face-to-face Physical Therapy on Pain, Physical Function and Quality of Life in individuals with Patellofemoral Pain Syndrome: A Single Blind Randomized Controlled Trial

the Effectiveness of Tele-rehabilitation Versus face-to-face Physical Therapy on Pain, Physical Function and Quality of Life

A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 60 patients. Random Allocation computer software (version 1.1, Isfahan University of Medical Sciences, Iran) is used for randomization.

Physical therapy clinics of the rehabilitation school of AJUMS.The treatment in the intervention group is performed in the form of Tele-rehabilitation and 3 face-to-face counseling sessions for 6 weeks and 3 sessions per week (18 sessions in total). Tele-rehabilitation is done through the vito app software. The treating physiotherapist is the same in both face-to-face treatment and Tele-rehabilitation groups. The evaluating physiotherapist is blinded to the groups.

Inclusion criteria: Age between 18 and 45 years, Access to the internet and mobile phone, Anterior knee pain following going up and down stairs, knee flexion and sitting for a long time, knee pain for at least 1 month Exclusion criteria: knee ligament instability, Knee meniscus pathologies, Patellar tendinopathy or Iliotibial Band tendinopathy, Knee joint effusion, Knee Subluxation or Dislocation or Fracture, Sinding-Larsen-Johansson syndrome, Plica syndrome, Osgood-Schlatter disease, Neuromuscular, rheumatologic or metabolic diseases, Having undergone conservative or surgical treatment of the affected knee less than 6 months previously

The intervention group will receive 18 sessions of muscle stretching exercises, muscle strengthening, balance and functional exercises through a remote rehabilitation software. The control group also receives the exercises in the clinic in person.

pain level, Physical function, Quality of life

After completing the outcome measurement tests before treatment intervention, people are divided into two groups of tele- rehabilitation treatment and face-to-face physical treatment group using the Permuted Block Stratified randomization method. In this method, the allocation of people into two groups is done with the same sample size - and also the balance of the groups is maintained in terms of the dispersion of the influential variables (age, gender, and activity level in this study). RandomAllocation computer software (version 1.1, Isfahan University of Medical Sciences, Iran) is used for randomization. First, a random order of two letters A (remote rehabilitation combined treatment group) and B (face-to-face physical therapy group) is made in blocks with random numbers of 4 and 6 (for example, ABBA and ABAABB). Then the blocks are hidden by the opaque envelope. The randomization process will be done by a person who is not involved in any of the other stages of the research.

Due to the fact that the type of study is such that the participants and the physiotherapist are aware of the type of intervention that participants receive, it is not possible to blind the patients and the physiotherapist. All evaluations are done by a physiotherapist who is not aware of the type of intervention that the participants receive. The people participating in the study are told not to disclose the type of intervention to the physiotherapist.

The data from primary outcomes will be available.

3 months after the published paper

Data will be available for researchers that work at Universities and scientific centers.

Responsiveness analysis can be done.

Contact with project executive manager email address: hessam_pt81@yahoo.com Contact with project assistance email address: negramir@yahoo.com referring to rehabilitation faculty of Ahvaz Jundishapur University of Medical Sciences

Researchers who want to use study data should give a written application to executive manager of the project and after consultation with other study team members , data will be available.