NCT06691880

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

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).

Conditions

• Subacute Stroke
• Acute Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-12
• Primary completion: 2025-03-12
• Completion: 2025-09-01
• First posted: 2024-11-18
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States