Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy for Patients With Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is the leading cause of disability in the United States. As
      osteoarthritis is associated with the lower limb muscle weakness, rehabilitation through
      quadriceps strengthening is a well-established treatment for patients with knee OA, but
      patient adherence to exercise routines is low due to lack of guidance regarding optimal
      protocols and lack of engagement during the repetitive routines that patients find tedious
      and boring.

      The Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy ("KneeBRIGHT")
      system combines electromyography (EMG) biofeedback with video game therapy to provide knee OA
      patients with an engaging, effective tool for conducting rehabilitation exercises at home.
      KneeBRIGHT aims to motivate patients with knee OA to conduct regular muscle strengthening
      exercise through an engaging, EMG-driven video game therapy.

      Overall goal of the program is to improve knee OA outcomes through effective and motivating
      rehabilitation exercises. Participants will be randomized to two groups: (1) KneeBRIGHT
      group; (2) Standard rehabilitation group. Both groups will undergo baseline and follow up
      assessment to measure the patient-reported outcomes and thigh muscle strength. Participants
      in both groups will undergo a 12-week program including 3 exercise sessions per week that
      includes a combination of in-person and at home sessions. Pre and post intervention outcome
      measures will be compared to explore the effectiveness. Technology acceptance will also be
      studied in patients randomized to KneeBRIGHT group.
    

Detailed description: 
      Osteoarthritis (OA) is the leading cause of disability in the United States. As
      osteoarthritis is associated with the lower limb muscle weakness, rehabilitation focused on
      quadriceps and other lower extremity muscle strengthening is a well-established treatment for
      patients with knee OA. However, patient adherence to exercise routines is low due to the lack
      of guidance regarding optimal protocols, and poor engagement during the repetitive routines
      that patients find tedious and boring.

      Long-term goal of this study is to improve knee OA outcomes through effective and motivating
      rehabilitation exercises. The Knee Biofeedback Rehabilitation Interface for Game-based Home
      Therapy ("KneeBRIGHT") system combines electromyography (EMG) biofeedback with video game
      therapy (VGT) to provide knee OA patients with an engaging, effective tool for conducting
      rehabilitation exercises at home. KneeBRIGHT aims to motivate patients with knee OA to
      conduct regular muscle strengthening exercise through an engaging, EMG-driven video game
      therapy.

      Participants with age from 40-75, with independent ambulation and with the diagnosis of knee
      OA made by x-ray and a score of at least 2 (out of 4) on the Kellgren-Lawrence OA
      radiographic classification system will be included in the study. Participants with
      psychiatric or cognitive impairment (e.g., dementia), symptomatic spine, hip, ankle, or foot
      disease other than OA that would interfere with assessment of the knee will be excluded.
      Participants with balance or vestibular disorders, peripheral neuropathy, skin conditions
      that prevent EMG electrode placement, prisoner, pregnant women (by report),
      non-English-speaking, individuals who are visually and/or hearing impaired will also be
      excluded.

      Eligible participants will be randomized to two groups: (1) KneeBRIGHT group; (2) Standard
      rehabilitation group. Both groups will undergo baseline and follow up assessment to measure
      the patient-reported outcomes and thigh muscle strength. Participants in both groups will
      undergo a 12-week program including 3 exercise sessions per week that includes a combination
      of in-person and at home sessions

      Both groups will undergo same rehabilitation protocol which will begin with sessions
      supervised in the clinic by the study team physical therapist and gradually home sessions
      will be added. Participants in KneeBRIGHT group will perform the quadriceps strengthening
      exercises with the video-games based activities. The EMG biofeedback units and video game
      w/laptop will be provided to the subjects for home use. Subjects will receive instruction on
      how to apply the EMG biofeedback unit and use of the video game. KneeBRIGHT Game Activities
      consists of an introduction of the player to the virtual world and the missions, the player
      customizes the personal avatar and completes a series of calibration contractions and
      practice exercises to gain familiarity with the game controls. Through the EMG system, a
      player's muscle contractions translate into physical movements of the avatar and control of
      vehicles within the virtual environment. Each quest-type challenge is designed to permit play
      in a seated, supine, supported standing, or freestanding position, based on an individual's
      physical status. User interactions with the game incorporate knee extension exercises and
      functional movements that provide optimal therapeutic benefits.

      Participants in both groups will undergo combination of home and in clinic sessions. Protocol
      will start with six clinic visits in order to maximize familiarity with the exercise routines
      and equipment. Home sessions will be added after 2 weeks in rehabilitation. The sessions will
      consist of warm up, strengthening, balance, precision and gentle stretching exercises.
      Strengthening exercises will be focused on quadriceps, hamstring, calf and gluteal muscles.
      Stretching exercises will be focused on quadriceps, hamstring and calf muscles. Progression
      will be guided by the rehabilitation principles and participants response to the exercise.
      The amount of these exercises will depend on how they make the subject feel. The
      rehabilitation program will allow the subject to increase the amount of exercise they can
      perform. Exercises will be limited if the subject feels discomfort. Overall, protocol will
      consist of 36 sessions in total, 20 in clinic sessions and 16 home-based sessions.

      Pre and post intervention outcome measures will be compared to explore the effectiveness.
      Technology acceptance will also be studied in patients randomized to KneeBRIGHT group.

      Overall, KneeBRIGHT has the potential to significantly enhance OA rehabilitation by improving
      functional recovery through physical practice of specific, adaptive exercise and promoting
      adherence through fun games and performance feedback. Use of the KneeBRIGHT system in
      teletherapy may increase access to remote/underserved areas and extend the range of existing
      rehabilitation facilities.

      Statistical analysis Knee function assessed by composite KOOS score prior to the study will
      be compared to the KOOS score recorded post-intervention to test the primary hypothesis that
      patients conducting the KneeBRIGHT exercise will significantly improve knee function compared
      to the control group. Pre-intervention KOOS scores measures will be subtracted from the
      post-intervention scores to produce a set of delta values. These delta values will be
      analyzed via Analysis of Covariance (ANCOVA). A p≤0.05 decision rule will be utilized as the
      rejection criterion.

      Questionnaire results will be used to test the hypothesis that patients using the KneeBRIGHT
      system demonstrate increased levels of engagement compared to those conducting a conventional
      exercise routine. The questionnaire scores will be tallied to produce composite scores. These
      composite scores will be analyzed via a linear mixed model. A p≤0.05 decision rule will be
      used as the null hypothesis rejection criterion.

      Timing data from the home visits will be analyzed by comparing the minutes of exercise with
      the KneeBRIGHT system to minutes of exercise with the standard exercise regimen in the
      control group to test the hypothesis that exercise duration is greater with the KneeBRIGHT
      system. Mean usage time on each system will be analyzed via Student's paired t-test, with P
      v≤0.05 as the null hypothesis rejection criterion.
    

Intervention name(s): KneeBright Group; Standard Rehabilitation group
Intervention type(s): Other; Other
Intervention description(s): The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
The KneeBRIGHT software will incorporates a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions.; Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants with knee osteoarthritis will be randomly assigned to Group 1 or 2. During each exercise session all the participants will perform stretching exercises, strengthening exercises and balance exercises. Dosage of exercises will be based on the rehabilitation principles and will be guided and progressed the way the participants feel about their knee health throughout the rehabilitation program.
Participants in Group1 (KneeBright group), will perform some of the exercises with the KneeBright Device and while playing a video game, while Group 2 will undergo standard knee rehabilitation exercises without the KneeBright device.
Both groups will undergo a 12 week program including 3 exercise sessions per week that include a combination of in-person and at home sessions. Participants in both groups will undergo 36 exercise sessions in total, each lasting for 1 hour. Among these 36 sessions 20 will be performed in clinic under supervision and 16 will be performed at home.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; video-game based interventions; strength; Precision