Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke

NCT03985761 | Completed Results DMC

• 2 other identifiers: AWD000043861R15HD095403-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Upper extremity; Hand; Arm; Virtual reality; Telerehabilitation; Gaming; Hemiparesis; Dexterity

Outcome Measures

Primary Outcomes (3)

• Total Intervention Time

  Total intervention time performed by patient during study period

  Day one through day ninety of intervention period

• Upper Extremity Fugl Meyer Assessment

  Difference between post test and pretest Upper Extremity Fugl Meyer Assessment Scores. Scores between 0 and 66. The Upper Extremity Fugl-Meyer Assessment is a clinical scale that is a composite measure of 33 performance based items, scored 0,1 or 2. Total score reflects the sum of the 33 individual item scores. Higher scores reflect better performance.

  12 weeks

• Intrinsic Motivation Inventory

  Difference between score measured three months after baseline and the score measured at baseline on the Intrinsic Motivation Inventory. Scores range = 0-84. Higher score equals higher levels of intrinsic motivation.

  12 weeks

Secondary Outcomes (3)

• Average Intervention Time Per Intervention Day

  Day one through day ninety of intervention period

• Action Research Arm Test

  12 weeks.

• Box and Blocks Test

  12 weeks

Other Outcomes (4)

• Stroke Impact Scale - Hand Subscale

  12 weeks.

• Stroke Impact Scale - Activities of Daily Living Subscale

  12 weeks.

• Total Training Sessions

  12 weeks

Study Arms (2)

Home Telerehabilitation_Motivation Enhanced HTme

EXPERIMENTAL

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

Home Telerehabilitation_Unenhanced (HTu)

ACTIVE COMPARATOR

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

Interventions

Home Telerehabilitation using HoVRS BEHAVIORAL

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.

Home Telerehabilitation_Motivation Enhanced HTme; Home Telerehabilitation_Unenhanced (HTu)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• New Jersey Institute of Technology: collaborator

Study Sites (1)

Rutgers The State University of New Jersey

Newark, New Jersey, 07107, United States

Location

Related Publications (41)

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• Fluet G, Qiu Q, Gross A, Gorin H, Patel J, Merians A, Adamovich S. The influence of scaffolding on intrinsic motivation and autonomous adherence to a game-based, sparsely supervised home rehabilitation program for people with upper extremity hemiparesis due to stroke. A randomized controlled trial. J Neuroeng Rehabil. 2024 Aug 13;21(1):143. doi: 10.1186/s12984-024-01441-7.

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  PMID: 38883760 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small number of subjects.

Results Point of Contact

• Title: Dr. Gerard G Fluet DPT, PhD
• Organization: Rutgers The State University of NJ

fluetge@shp.rutgers.edu

(973) 972-8529

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: June 14, 2019
• Study Start: September 8, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)