Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This trial studies the impact of motivational strategies designed by the gaming industry on
      adherence to a home tele-rehabilitation program designed to improve hand function in persons
      with stroke. A growing literature suggests that the extended practice of challenging hand
      tasks can produce measurable changes in hand function in persons with stroke. Current health
      care delivery systems do not support this volume of directly supervised rehabilitation,
      making it necessary for patients to perform a substantial amount of activity at home,
      unsupervised. Unfortunately, adherence to unsupervised home exercise regimens is quite poor
      in this population. The investigator's goal is to assess the impact of several
      well-established game design strategies: 1) Scaffolded increases in game difficulty 2)
      In-game rewards 3) Quests with enhanced narrative. The investigator's will utilize these
      enhancements to study their impact on motivation to perform a tele-rehabilitation- based home
      exercise program, adherence to the program and changes in hand function. The proposed study
      will utilize a system of novel rehabilitation technologies designed to facilitate home
      exercise performance. Subjects will perform 3 simulated rehabilitation activities supported
      by a passive exoskeleton, an infrared camera and software that will allow subjects to
      exercise at home. The investigator's will investigate: 1) Differences in measures of
      motivation elicited by motivationally enhanced simulations and un-enhanced control
      versions.2) The impact of motivational enhancements on actual adherence to a
      tele-rehabilitation program in persons with stroke and 3) The impact of motivational
      enhancement on improvements in hand function achieved by these subjects. This proposal will
      address a critical gap in modern rehabilitation - adherence to autonomous rehabilitation
      programs. Patient participation in unsupervised rehabilitation is one of the assumptions
      underpinning our health care system. This said, no data collected to date supports that
      adherence is acceptable. The technology and methodology in this proposal are an important
      step towards leveraging extensive research and development done by the computer gaming
      industry into improved rehabilitation practice.
    

Detailed description: 
      1. Purpose/Specific Aims The overarching aim of this study is to provide a mechanism for
           patients to engage in progressive motor practice for a meaningful time period. The
           investigator's aim to improve on the positive outcomes demonstrated in patients in the
           chronic phase and the pilot work being done on patients in the acute in-patient phase
           post stroke to determine whether functional recovery can be further improved using a
           home based system.

           Aim 1: Evaluate compliance with Home-Telerehabilitation simulated hand/arm gaming
           activities and two computer game groups, one with motivation enhanced: Home Training
           Motivation Enhanced (HTme) simulations and one with non-enhanced simulations: Home
           Training Unenhanced (HTu) versions. Hypothesis: Participants in the HTme group will show
           significant compliance as compared to the control group (HTu).

           Aim 2: Evaluate the effectiveness of motivation enhanced HTme home-based virtually
           simulated hand/arm gaming activities for individuals with stroke as compared to a
           program unenhanced HTu versions of the same simulations. Hypothesis: Participants
           completing HTme training will exhibit significantly improved clinical, kinematic and
           neurophysiological outcomes as compared to the control group (HTu).

           Aim 3: Evaluate the impact of the motivation enhancements designed into computer games
           to provide a more enjoyable training experience. Hypothesis: Enjoyment of the games will
           be a more valid predictor of compliance than personal factors.

        2. Background and Significance Studies have shown that sustained hand rehabilitation
           training is important for continuous improvement and maintenance of function following a
           stroke. It is unimaginably difficult to pursue education, employment and community
           participation without being able to independently use one's hands. The primary goal of
           this study is to test an exciting new technology that can be easily used in the home for
           long-term hand and upper extremity training. Recovery of hand function post brain injury
           is particularly recalcitrant to currently available interventions. To date, the best
           efforts of groups studying traditionally presented as well as technology-based
           therapeutic interventions for the hemiplegic hand and arm have produced measurable
           changes in motor function and motor control but fall far short of major reductions in
           disability.

           If the amount of therapy is critical to rehabilitation, our current institutional
           limitations undermine the probabilities for successful outcomes. After discharge from
           the inpatient stay, access to rehabilitation therapy can be difficult for some patients.
           This is due in part to inadequate insurance, lack of transportation, and the patient's
           dependence on their caregiver. Having access to long-term rehabilitation training
           anywhere and at any time is necessary for sub-acute and chronic patients to continuously
           improve their functional abilities.

        3. Research Design and Methods This study will be a single blind randomized controlled
           trial. Subjects will be blinded to the purpose of the study. All outcome measures will
           be performed by a therapist blinded to group assignment. A controlled trial will be
           utilized to determine the additive effect of presenting rehabilitation activities in a
           virtual environment as compared to standard upper extremity exercise. The investigators
           will randomize subjects to treatment and control groups using a computerized random
           number generator.

           3.1. Duration of Study

           Each subject will perform a pre-study evaluation, train using one of the protocols for
           three months, perform a post study evaluation as well as one and six month retention
           evaluations.

           3.2 Study Sites Testing and initial training will take place in the Bergen Building of
           the Rutgers Biomedical and Health Sciences Campus in Newark. Home training will take
           place in subjects' homes.

           3.3 Sample Size Justification The investigators will seek sufficient power to detect a
           clinically significant difference in the Wolf score changes in these two pre-planned,
           primary comparisons. To evaluate these effects of training, we will assume a power level
           of .8 and a significance level of 0.05. With presumed correlation among repeated
           measures of 0.1 and effect size of 0.3, a sample size of 25 subjects in each of the two
           groups (HTme and HTu) to observe a significant effect for the first comparison (G*Power,
           version 3.1.5) is necessary. Although the investigators will screen for patients with
           homogeneous impairments, by its nature stroke is an extremely variable condition. Due to
           possible subject attrition, the investigators will use a total of 30 subjects in each of
           the two groups.

           3.4 Subject Recruitment Subjects will be recruited through flyers, stroke support
           groups, and clinician referrals. The investigators will assume that approximately 15-20%
           of the population will satisfy our inclusion criteria based on our previous experience
           with upper extremity rehabilitation in this population. Hence the investigators will
           approach 300 persons.

           3.5 Consent Procedures Example: The study will be explained to the potential subject by
           the study staff, the consent will be read, and their questions will be answered. If
           participants wish to enroll, the subject will sign the consent form. The study staff
           obtaining consent will also sign and date the consent form, and a copy will be given to
           the subject sought from each prospective subject or the subject's legally authorized
           representative, in accordance with federal & state law and institutional policy. If the
           study staff member performing the consent process identifies issues suggesting that the
           prospective subject may not be capable of participating in the consent process due to
           dementia, a Folstein Mini Mental Status will be performed. Prospective subjects
           screening positive for dementia will not be included in the study.

           3.5.1 Subject Costs and Compensation There are no costs for the subjects. The subjects
           will be paid 100$ at each of the retention tests.

        4. Study Variables

           4.1 Independent Variables or Interventions

           The two computer game groups, Motivation Enhanced (HTme) and Motivation Non-Enhanced
           (HTu) will use the NJIT- Home Virtual Rehabilitation System (HoVRS) to play a series of
           computer games developed to practice movement of the hand and fingers. Subjects will
           first come into our lab, perform pre-tests as well as a pre-intervention training
           session. Then a physical therapist and engineer will set up the apparatus in subject's
           home and will train them on how to use the system and play the games in their home
           during the first week. The physical therapist and engineer will be in contact with
           subjects throughout the training and will visit subjects' homes as needed if problems
           are encountered. Additionally, the system allows the therapist to remotely monitor each
           day's activity.

           4.1.1 Device Description NJIT HoVRS has two sub-systems to deliver home-based training:
           1) a patient based platform to provide the training and 2) a server based online data
           logging and reporting system. In the patient's home, a cross platform virtual reality
           training application runs video games (developed in the Unity 3D game engine using the
           language C#) on their home computer.

           4.1.11 Hardware The Leap Motion Controller (LMC) a commercially developed infrared
           tracking device developed for home video game control is used to capture motion of the
           hand and arm movement without requiring wearable sensors. The device's USB controller
           reads the sensor data into its own local memory and performs any necessary resolution
           adjustments. This data is then streamed via USB to the Leap Motion image Application
           Programming Interface (API). From there, we programmed the system to feed tracking data
           into virtual reality activities by calling the Leap Motion API.

           If the patient's arm is weak and cannot support the hand against gravity above the Leap
           Motion Controller, a commercially available, spring-based arm support, will be provided
           to the subject (Figure 1). The arm support provides 12 different levels of passive
           support allowing it to accommodate a wide range of patient sizes and strength levels. It
           requires a single setting that can be provided during the patient's initial evaluation

           4.1.1.2 Software Patients will either use their own home computer or will be provided
           with a computer if needed. A user-friendly Graphic User Interface (GUI) lists all of the
           training activities allowing patients to choose which activity they want to begin with
           using just one mouse click. Currently twelve games have been developed, each one
           designed to focus on training a specific hand or arm movement such as wrist rotation or
           finger individuation. All games are downloadable via HoVRS website.

           4.2 Dependent Variables: See Outcomes Measures

           4.3 Risk of Harm

           There is less than minimal risk involved. The virtual reality (VR) experiments are
           non-invasive and pose no obvious risk. Transient fatigue of the hand and arm are
           possible, but this risk is not greater than that posed by normal daily activities
           following a stroke.

           4.4 Potential for Benefit The benefits of taking part in this study may be: Patient may
           regain better use of their hand and arm. However, it is possible that patients might
           receive no direct personal benefit from taking part in this study.

        5. Data Handling and Statistical Analysis All efforts will be made to keep subjects'
           personal information confidential. All subject names will be removed from the data and
           the data will be tagged using a coded identification (ID) number. Demographic, clinical
           outcome and survey data will first be recorded on paper. All kinematic and computerized
           performance data will be collected on computer. These computer files will be identified
           by the coded subject ID number. All data will be transferred to an Excel spreadsheet
           with subjects identified by this same ID number. Spreadsheets will be stored on a drive
           that is password protected. Data will only be accessible to study staff and will be
           retained for seven years. The link between subject identity and subject ID number will
           be destroyed when data collection is completed.

      The primary outcome measures and all secondary outcome measures described above will be
      subjected to a repeated measured analysis of variance, with between-group factors Therapy
      Type (HTme, HTu) and within-group factor Test (Before, Post, One Month retention, Six Months
      Retention). Post-hoc analyses of the Therapy Type by Test interaction effects will focus on
      the Month 1 versus Month 6 comparison. The investigators will be quantifying training effects
      by comparing group means as well as by percent change in performance, and by comparing the
      recovery curves obtained from Tests 1-4. All clinical outcomes used are well established
      measures of upper extremity functional recovery with published minimum clinically important
      differences which will be used to evaluate the significance of our findings.

      7. Reporting Results

      7.1 Individual Results No disease screening data will be collected. Patient's changes on
      clinical tests will be shared with them during testing sessions. These sessions are conducted
      by licensed Physical Therapists who have training to help persons with stroke interpret
      clinical examination findings.

      7.2 Aggregate Results Subjects will not be informed of aggregate findings.

      7.3 Professional Reporting De-identified, aggregate findings will be published in
      professional journals and presented at scientific meetings.
    

Intervention name(s): Home Telerehabilitation using HoVRS
Intervention type(s): Behavioral
Intervention description(s): The Home Virtual Rehabilitation System (HoVRS) integrates a Leap Motion controller, a passive arm support and a suite of custom designed hand rehabilitation simulations. The Leap Motion provides camera based measurement of finger joint positions, allowing for integrated virtual arm and finger training. If the patient's arm is severely impaired, a forearm orthosis that counter-balances gravity to provide graded support to the arm during activity is issued to the subject. In this study, we utilize 3 task-based simulations that train hand manipulation and arm transport. One simulation trains hand opening integrated with pronation and supination, a second trains wrist movement, by presenting targets that subjects navigate a plane over and around buildings to collect, a third simulation, trains shoulder and elbow disassociation in a horizontal plane integrated with hand opening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Upper extremity; Hand; Arm; Virtual reality; Telerehabilitation; Gaming; Hemiparesis; Dexterity