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Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03985761
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
New Jersey Institute of Technology
Information provided by (Responsible Party):
Gerard G Fluet DPT, PhD, Rutgers, The State University of New Jersey

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Home Telerehabilitation using HoVRS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
Actual Study Start Date : September 8, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
Experimental: Home Telerehabilitation_Motivation Enhanced HTme
The Home Telerehabilitation Motivation Enhanced (HTme) group will use the NJIT-HoVRS system to play a series of three games to train movement of their shoulder, elbow, wrist and fingers. The study team will set up the apparatus in their home at the initial visit and train them to use the system. After this, subjects will practice in their homes with on-line or in-person support as needed (once a week in person for the first month, and then an average of two times per month in person and two times per month on line). Subjects will be instructed to perform three of the simulations assigned to them as much as possible, but at least twenty minutes, daily for twelve weeks. The HTme group will use three simulations that will provide the user with eight to twelve levels of gradually increasing difficulty and complexity. A screen announces each level change and the graphics for each new level change substantially. Scoring opportunities increase at each new level.
Behavioral: Home Telerehabilitation using HoVRS
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.

Active Comparator: Home Telerehabilitation_Unenhanced (HTu)
The Home Telerehabilitation Motivation Enhanced (HTu) group will use the NJIT-HoVRS system to play a series of three games to train movement of their shoulder, elbow, wrist and fingers. The study team will set up the apparatus in their home at the initial visit and train them to use the system. After this, subjects will practice in their homes with on-line or in-person support as needed (once a week in person for the first month, and then an average of two times per month in person and two times per month on line). Subjects will be instructed to perform three of the simulations assigned to them as much as possible, but at least twenty minutes, daily for twelve weeks. The HTu group will use three simulations. Difficulty will be increased utilizing an adaptive control algorithm that increases difficulty based on performance. Difficulty changes are extremely incremental making them imperceptible for most subjects. Graphics and scoring do not change as difficulty level changes.
Behavioral: Home Telerehabilitation using HoVRS
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.




Primary Outcome Measures :
  1. Total intervention time [ Time Frame: Day one through day ninety of intervention period ]
    Total intervention time performed by patient during study period

  2. Upper extremity Fugl Meyer Assessment [ Time Frame: One day prior to intervention ]
    Behavioral test of upper extremity motor function

  3. Upper extremity Fugl Meyer Assessment [ Time Frame: One day after intervention ]
    Behavioral test of upper extremity motor function

  4. Upper extremity Fugl Meyer Assessment [ Time Frame: One month after intervention ]
    Behavioral test of upper extremity motor function

  5. Intrinsic Motivation Inventory [ Time Frame: First day intervention period ]
    Survey examining subjective response to rehabilitation program

  6. Intrinsic Motivation Inventory [ Time Frame: Day 90 of intervention period ]
    Survey examining subjective response to rehabilitation program


Secondary Outcome Measures :
  1. Number of intervention days [ Time Frame: Day one through day ninety of intervention period ]
    Number of self-initiated intervention days performed by patient during study period

  2. Average intervention time per intervention day [ Time Frame: Day one through day ninety of intervention period ]
    Average intervention time performed by the subject

  3. Action Research Arm Test [ Time Frame: 1 day prior to intervention period. ]
    Behavioral test of upper extremity motor function

  4. Action Research Arm Test [ Time Frame: 1 day after intervention period. ]
    Behavioral test of upper extremity motor function

  5. Action Research Arm Test [ Time Frame: 1 month after intervention period. ]
    Behavioral test of upper extremity motor function

  6. Box and Blocks Test [ Time Frame: 1 day before intervention period. ]
    Behavioral test of upper extremity motor function

  7. Box and Blocks Test [ Time Frame: 1 day after intervention period. ]
    Behavioral test of upper extremity motor function

  8. Box and Blocks Test [ Time Frame: 1 month after intervention period. ]
    Behavioral test of upper extremity motor function

  9. Nine Hole Peg Test [ Time Frame: 1 day before intervention period. ]
    Behavioral test of upper extremity motor function

  10. Nine Hole Peg Test [ Time Frame: 1 day after intervention period. ]
    Behavioral test of upper extremity motor function

  11. Nine Hole Peg Test [ Time Frame: 1 month after intervention period. ]
    Behavioral test of upper extremity motor function

  12. Stroke Impact Scale - Activities of Daily Living Subscale [ Time Frame: 1 day before intervention period. ]
    Fifty point subscale. Higher score = better recovery. Subscales reported individually.

  13. Stroke Impact Scale - Activities of Daily Living Subscale [ Time Frame: 1 day after intervention period. ]
    Fifty point subscale. Higher score = better recovery. Subscales reported individually.

  14. Stroke Impact Scale - Activities of Daily Living Subscale [ Time Frame: 1 month after intervention period. ]
    Fifty point subscale. Higher score = better recovery. Subscales reported individually.

  15. Stroke Impact Scale - Hand Subscale [ Time Frame: 1 day before intervention period. ]
    Twenty five point subscale. Higher score = better recovery. Subscales reported individually.

  16. Stroke Impact Scale - Hand Subscale [ Time Frame: 1 day after intervention period. ]
    Twenty five point subscale. Higher score = better recovery. Subscales reported individually.

  17. Stroke Impact Scale - Hand Subscale [ Time Frame: 1 month after intervention period. ]
    Twenty five point subscale. Higher score = better recovery. Subscales reported individually.

  18. Stroke Impact Scale - Participation Subscale [ Time Frame: 1 day before intervention period. ]
    Forty point subscale. Higher score = better recovery. Subscales reported individually.

  19. Stroke Impact Scale - Participation Subscale [ Time Frame: 1 day after intervention period. ]
    Forty point subscale. Higher score = better recovery. Subscales reported individually.

  20. Stroke Impact Scale - Participation Subscale [ Time Frame: 1 month after intervention period. ]
    Forty point subscale. Higher score = better recovery. Subscales reported individually.

  21. Stroke Impact Scale - Recovery Subscale [ Time Frame: 1 day before intervention period. ]
    One hundred point subscale. Higher score = better recovery. Subscales reported individually.

  22. Stroke Impact Scale - Recovery Subscale [ Time Frame: 1 day after intervention period. ]
    One hundred point subscale. Higher score = better recovery. Subscales reported individually.

  23. Stroke Impact Scale - Recovery Subscale [ Time Frame: 1 month after intervention period. ]
    One hundred point subscale. Higher score = better recovery. Subscales reported individually.

  24. Hand opening/closing range of motion [ Time Frame: 1 day before intervention period. ]
    Sum of maximum angular excursions of the paretic metacarpo-phalangeal (MCP), proximal inter-phalangeal(PIP) and distal inter-phalangeal joints (DIP) joints during a hand opening activity

  25. Hand opening/closing range of motion [ Time Frame: 1 day after intervention period. ]
    Sum of maximum angular excursions of the paretic metacarpo-phalangeal (MCP), proximal inter-phalangeal(PIP) and distal inter-phalangeal joints (DIP) joints during a hand opening activity

  26. Hand opening/closing range of motion [ Time Frame: 1 month after intervention period. ]
    Sum of maximum angular excursions of the paretic metacarpo-phalangeal (MCP), proximal inter-phalangeal(PIP) and distal inter-phalangeal joints (DIP) joints during a hand opening activity

  27. Hand trace RMSE [ Time Frame: 1 day before intervention period. ]
    Ability to control hand opening as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  28. Hand trace RMSE [ Time Frame: 1 day after intervention period. ]
    Ability to control hand opening as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  29. Hand trace RMSE [ Time Frame: 1 month after intervention period. ]
    Ability to control hand opening as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  30. Wrist Trace RMSE [ Time Frame: 1 day before intervention period. ]
    Ability to control wrist flexion and extension as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  31. Wrist Trace RMSE [ Time Frame: 1 day after intervention period. ]
    Ability to control wrist flexion and extension as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  32. Wrist Trace RMSE [ Time Frame: 1 month after intervention period. ]
    Ability to control wrist flexion and extension as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  33. Horizontal shoulder and elbow trace RMSE [ Time Frame: 1 day before intervention period. ]
    Ability to control shoulder and elbow as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  34. Horizontal shoulder and elbow trace RMSE [ Time Frame: 1 day after intervention period. ]
    Ability to control shoulder and elbow as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  35. Horizontal shoulder and elbow trace RMSE [ Time Frame: 1 month after intervention period. ]
    Ability to control shoulder and elbow as subject moves a cursor tracking a sine wave. Reported as root mean square error (RMSE) comparing target position and cursor position.

  36. Twenty four hour upper limb activity magnitude ratio [ Time Frame: Between 96 and 72 hours prior to pretest ]
    Participant will wear tri-axial accelerometers on both wrists for twenty four hours and upper limb magnitude ratio will be calculated and reported as per Bailey (2015). For each second of this twenty four hour period accelerations across the three axes are combined into a single vector magnitude value. Inactive non-paretic UE is assigned a vector magnitude of -7 when paretic UE is moving alone. Inactive paretic UE is assigned a vector magnitude of 7 when non-paretic UE is moving alone. Paretic wrist vector magnitude will be divided by non-paretic wrist vector magnitude for each second. These calculated values will be transformed using a natural logarithm to prevent skewness of positive, untransformed values. Median of these values for the twenty four hour period will be reported for each individual subject.

  37. Twenty four hour upper limb activity magnitude ratio [ Time Frame: Between 48 and 24 hours prior to pretest ]
    Participant will wear tri-axial accelerometers on both wrists for twenty four hours and upper limb magnitude ratio will be calculated and reported as per Bailey (2015). For each second of this twenty four hour period accelerations across the three axes are combined into a single vector magnitude value. Inactive non-paretic UE is assigned a vector magnitude of -7 when paretic UE is moving alone. Inactive paretic UE is assigned a vector magnitude of 7 when non-paretic UE is moving alone. Paretic wrist vector magnitude will be divided by non-paretic wrist vector magnitude for each second. These calculated values will be transformed using a natural logarithm to prevent skewness of positive, untransformed values. Median of these values for the twenty four hour period will be reported for each individual subject.

  38. Twenty four hour upper limb activity magnitude ratio [ Time Frame: Between 24 and 48 hours after to post-test ]
    Participant will wear tri-axial accelerometers on both wrists for twenty four hours and upper limb magnitude ratio will be calculated and reported as per Bailey (2015). For each second of this twenty four hour period accelerations across the three axes are combined into a single vector magnitude value. Inactive non-paretic UE is assigned a vector magnitude of -7 when paretic UE is moving alone. Inactive paretic UE is assigned a vector magnitude of 7 when non-paretic UE is moving alone. Paretic wrist vector magnitude will be divided by non-paretic wrist vector magnitude for each second. These calculated values will be transformed using a natural logarithm to prevent skewness of positive, untransformed values. Median of these values for the twenty four hour period will be reported for each individual subject.

  39. Twenty four hour upper limb activity magnitude ratio [ Time Frame: Between 72 and 96 hours after to post-test ]
    Participant will wear tri-axial accelerometers on both wrists for twenty four hours and upper limb magnitude ratio will be calculated and reported as per Bailey (2015). For each second of this twenty four hour period accelerations across the three axes are combined into a single vector magnitude value. Inactive non-paretic UE is assigned a vector magnitude of -7 when paretic UE is moving alone. Inactive paretic UE is assigned a vector magnitude of 7 when non-paretic UE is moving alone. Paretic wrist vector magnitude will be divided by non-paretic wrist vector magnitude for each second. These calculated values will be transformed using a natural logarithm to prevent skewness of positive, untransformed values. Median of these values for the twenty four hour period will be reported for each individual subject.


Other Outcome Measures:
  1. Patient experience with HoVRS training [ Time Frame: Interview will be conducted 30 days immediately after the intervention period. ]
    Qualitative data related to subjects experience during the testing and training periods will be collected using a structured interview.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. unilateral stroke
  2. score of 22 or greater on the Montreal Cognitive Assesment
  3. Score of 1 or better on extinction and inattention portion of NIH Stroke Scale
  4. Fugl-Meyer (FM) between 36-58/66 (
  5. Score of 1 or better on language portion of NIHSS
  6. intact cutaneous sensation (ability to detect <4.17 Newton stimulation using Semmes-Weinstein nylon filaments)

Exclusion Criteria:

Orthopedic issues that would limit the ability to perform regular upper extremity activity


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985761


Contacts
Layout table for location contacts
Contact: Gerard G Fluet, DPT, PhD (973) 972-8529 fluetge@shp.rutgers.edu
Contact: Qinyin Qiu, PhD (973) 972-8529 qiuqi@shp.rutgers.edu

Locations
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United States, New Jersey
Rutgers The State University of New Jersey Recruiting
Newark, New Jersey, United States, 07107
Contact: Gerard Fluet, DPT, PhD    732-986-8621    fluetge@shp.rutgers.edu   
Contact: Qinyin Qiu, PhD    (732)986-8621    qiuqi@shp.rutgers.edu   
Sub-Investigator: Alma Merians, PT, PhD         
Sub-Investigator: Sergei Adamovich, PhD         
Principal Investigator: Gerard Fluet, DPT, PhD         
Sub-Investigator: Qinyin Qiu, PhD         
Sub-Investigator: Catherine Myers, PhD         
Sub-Investigator: Scott Parrott, PhD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
New Jersey Institute of Technology

Publications:

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Responsible Party: Gerard G Fluet DPT, PhD, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03985761     History of Changes
Other Study ID Numbers: AWD00004386
1R15HD095403-01 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Immediately following completion of our proposed study we will submit a de-identified data set our protocol and links to published papers based on the data set to the Centralized Open Access Rehabilitation Data Base for Stroke (SCOAR).
Supporting Materials: Study Protocol
Time Frame: We will make our data available immediately after study completion. Data will remain available indefinitely.
Access Criteria: Not Applicable - Open Access
URL: http://keithlohse.github.io/SCOAR_data_viz/#

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gerard G Fluet DPT, PhD, Rutgers, The State University of New Jersey:
Stroke
Upper extremity
Hand
Arm
Virtual reality
Telerehabilitation
Gaming
Hemiparesis
Dexterity
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases