Feasibility of Video Gaming Technology for Arm Recovery Early Post-stroke (SMARTER)

March 12, 2026 updated by: Johns Hopkins University

Translating SMARTS 2: the Integration of Video Gaming Technology Into Traditional Rehabilitation

The investigators are investigating ways to incorporate new technologies that can enhance functional outcome after neurological insult into the patient recovery space. In order to accelerate the translation of these technologies to patient care spaces, the investigators need to identify the locations that are feasible for its use. Currently the investigators are using video game technologies that are used to maximize motor recovery of impaired upper extremities after neurological insult in the outpatient (clinic) setting. These technologies interface with robotics and other hardware to create a therapy experience that is fun, engaging, dynamic, challenging, and promotes repetitions that are otherwise difficult to achieve during conventional post-stroke rehabilitation. The investigators think early use of these technologies could enhance recovery of the arm, but It is not known if use of these technologies in the early post-stroke recovery period is safe and feasible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study explores a protocolized approach to high-dosed, video-game-based arm training in addition to standard of care rehabilitation in the acute/sub-acute phase of stroke recovery. Patients admitted to the Johns Hopkins Hospital rehabilitation unit or the Brain Rescue Unit with new unilateral upper limb weakness as a result of the patient's sequela will be considered for enrollment. Once consented, participants will be seen 4-5 days per week for up to 60 minutes of additional arm training using gaming technology. Participant response to training will be measured before and after the intervention and function and impairment level will be measured pre and post the training protocol. Participants will be expected to participate in the training protocol for the duration of the hospital stay.

The study involves patients who were already hospitalized at a large teaching institution in Maryland. Participants were screened for eligibility on admission to the hospital. If eligible, the patient was screened in person to determine if he/she was able to follow a 1 step functional command and for willingness to participate. Once agreeable, patients and/or the patient's surrogate decision makers were consented to enroll into the study. Patients were included if a stroke was confirmed by CT or MRI with subsequent unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in Manual Muscle Testing (MMT) score from unaffected side to affected side). Patients were excluded if unable to sit upright for at least 5 minutes in a chair without arm support, unable to follow 1 step functional commands or had a vision impairment that impeded seeing the television screen. Patients were also excluded if the patient had medical instability as defined by the care provider, orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity, heart conditions that limits participation in exercise, active seizures or epilepsy or the inability to communicate pain status.

Once consented, baseline assessments are administered and include the FM-UE and dynamometry. The patients are stratified to a gaming technology based on the baseline FM-UE score. Patients with a FM-UE less than 25 are placed in the Bimanual Arm Training group. During the treatment session, the patients are monitored for tolerance of the session using pre and post vitals including Blood Pressure, Heart Rate, and pulse oximetry. Pre/post pain and fatigue ratings are also maintained using a 10 point-likert scale. Trained clinicians gathered session start and end time. Technological difficulties and other interruptions are documented. Adverse events are gathered and include any swelling or bruising, cut/scratch/irritations, and new numbness or tingling. Intervention clinicians use a detailed stopping criteria to monitor the patient for tolerance and participation in the target time on task. The subjects receive intervention daily outside of the subject's regularly scheduled therapy for the 4-5 days a week (pending clinician availability) for the length of the hospital stay.

On the day of or day prior to discharge, FM-UE and dynamometry is gathered again. Qualitative post-intervention outcome measures are gathered for and included a survey of the patient's experience using a Likert-Scale based questionnaire, a Technology Acceptance Model survey (examines the patient's experience using technology and breaks it down into previously defined domains: Perceived Ease of Use (PEU), Perceived Usefulness (PU), Attitude Toward Using (ATU), Behavioral Intention to Use (BIU), and the Intrinsic Motivation Inventory (IMI).

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Admitted to Meyer 7 inpatient rehabilitation unit (CIIRP) or Zayed 12 West (12W) Brain Rescue Unit (BRU)
  2. Unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in MMT score from unaffected side to affected side)

Exclusion Criteria:

  1. Unable to sit upright for at least 3 minutes
  2. Unable to follow 1 step commands
  3. Vision impairment that impedes seeing the television screen
  4. Medical instability as defined by the care provider
  5. Orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity
  6. Heart condition that limits participation in exercise
  7. Active seizures or epilepsy
  8. Inability to communicate pain status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Gaming Technology (VGT) based arm training
Patients who meet inclusion criteria will be assessed for level of arm impairment and allocated to either MindPod VGT or Bimanual Arm Trainer VGT based on the severity of impairment. Patients will complete up to 60 minutes of VGT treatment in addition to the standard of care therapy (Physical, occupational, and or speech therapy). Patients will be monitored before, during, and after the sessions for tolerance and response to the treatment. This will include physiological response using measures such as blood pressure, heart rate, and pulse oximeter. Self reported pain and fatigue will be collected using visual analog scales. Safety issues that are predefined as line dislodgement, falls, change in vital signs or pain necessitating interruption of the therapy session will be measured and calculated as the number of adverse events as a proportion of the number of sessions attended
Behavioral: MindPod Dolphin VGT
The MindPod Dolphin, is an interactive video game that allows users to engage in "non-task-based tasks" to motivate the users to play and relearn motor skills. The MindPod gaming platform uses markerless tracking to sense the patient's affected arm. The paretic limb controls Bandit the dolphin underwater in an effort to eat fish. The patient learns to map his/her movements to Bandit in a 3-Dimensional work space to reach the targets. During gaming, the therapist titrates game difficulty. Bilateral gaming components are used (the participant uses a controller with the participant's less-affected limb to control the timing of Bandit's movement) and in-game difficulty can be adjusted to create an immersive, challenging, and engaging experience. In order to be successful, the patient must coordinate both arms to control the temporal and spatial aspects of the game.
Behavioral: Bimanual Arm Trainer VGT
The bimanual arm trainer (BAT) is a device that involves hardware that interfaces with a computer game. The BAT promotes shoulder external rotation and elbow extension in the paretic arm by coupling movements of the paretic arm with the less affected limb as the participant matches his/her arm movements to those of a virtual avatar. The less-affected side and paretic limb are placed in the BAT apparatus and the less affected limb "drives" the impaired limb through passive, symmetrical movements that simulate rowing down a virtual river. The protocol created by the investigators group, leads the patient through an active-passive training progression similar to paradigms used in neural priming studies. Through these series of movements, the goal is to restore balance between the muscles of the upper back and chest to maximize range of motion in preparation for improved quality of movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Adherence to the protocol as assessed by session attendance
Time Frame: Immediately Post Intervention
Adherence to the protocol will be calculated by determining the number of sessions attended as a proportion of the number of possible sessions.
Immediately Post Intervention
Feasibility: Efficiency (total time on task)
Time Frame: Immediately Post Intervention
Efficiency will be calculated by examining the amount of practice (Total time on task) as a proportion of total minutes (Total protocol target duration).
Immediately Post Intervention
Feasibility: Acceptability of the intervention as assessed by the Technology Acceptance Measure
Time Frame: Post intervention up to 2 weeks
Technology Acceptance Measure; scale range is 1-7 (Strongly disagree to Strongly agree) and higher scores indicate better acceptability.
Post intervention up to 2 weeks
Feasibility: Acceptability of the intervention as assessed by the Intrinsic Motivation Inventory
Time Frame: Post Intervention up to 2 weeks
Acceptability of the intervention will be gathered using the Intrinsic Motivation Inventory. This is a 19-item inventory using a 1-7 scale (not at all true to very true) with 3 sub scales: Interest/Enjoyment, Value/Usefulness, Effort/Importance. Higher scores indicate high acceptability.
Post Intervention up to 2 weeks
Heart rate
Time Frame: Baseline, Immediately Post-Intervention
Heart rate; mean number of beats per minute.
Baseline, Immediately Post-Intervention
Blood pressure (mmHg)
Time Frame: Baseline, Immediately Post-Intervention
Systolic and diastolic blood pressure.
Baseline, Immediately Post-Intervention
Pain as assessed by Wong-Baker Faces Pain Rating Scale
Time Frame: Baseline, Immediately Post-Intervention
Pain score; (0-10) 10 indicates high level of pain
Baseline, Immediately Post-Intervention
Fatigue as assessed by Fatigue Visual Analog Scale
Time Frame: Baseline, Immediately Post-Intervention
Fatigue score; 0-10 with 10 being greater levels of fatigue
Baseline, Immediately Post-Intervention
Safety as assessed by the number of adverse events
Time Frame: Baseline, Immediately Post-Intervention
Safety as assessed by the number of adverse events.
Baseline, Immediately Post-Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Fugl Meyer Upper Extremity
Time Frame: Baseline, Immediately Post-Intervention
66-point scale that looks at change in arm and hand function at the impairment level as assessed by the Fugl Meyer Upper Extremity Assessment of motor control (FM-UE). The FM-UE uses a 3-point ordinal scale to evaluate sensorimotor function of the arm and hand of the affected upper extremity during reach and grasp movements in and out of synergistic movement patterns. Total scores of 66 are equal to normal movement or no impairment.
Baseline, Immediately Post-Intervention
Efficacy: Gross Grasp (Dynamometry)
Time Frame: Baseline, Immediately Post-Intervention
Change in gross grasp will be captured using dynamometry measured in pounds of force output. Three measures will be taken on the right and left hand and the value will be averaged using a calibrated dynamometer and standardized testing procedure. Greater force output is equal to greater grip strength.
Baseline, Immediately Post-Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Mona Bahouth, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2020

Primary Completion (Actual)

March 12, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00204731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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