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

Not Applicable

Recruiting

• Conditions: Subacute Stroke; Acute Stroke

• Registration Number: NCT06691880
• Lead Sponsor: Johns Hopkins University

Brief 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).

Study Timeline

• Study Start: 2020-09-20
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-03-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility: Adherence to the protocol as assessed by session attendance	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.
Feasibility: Efficiency (total time on task)	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).
Feasibility: Acceptability of the intervention as assessed by the Technology Acceptance Measure	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.
Feasibility: Acceptability of the intervention as assessed by the Intrinsic Motivation Inventory	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.
Heart rate	Baseline, Immediately Post-Intervention	Heart rate; mean number of beats per minute.
Blood pressure (mmHg)	Baseline, Immediately Post-Intervention	Systolic and diastolic blood pressure.
Pain as assessed by Wong-Baker Faces Pain Rating Scale	Baseline, Immediately Post-Intervention	Pain score; (0-10) 10 indicates high level of pain
Fatigue as assessed by Fatigue Visual Analog Scale	Baseline, Immediately Post-Intervention	Fatigue score; 0-10 with 10 being greater levels of fatigue
Safety as assessed by the number of adverse events	Baseline, Immediately Post-Intervention	Safety as assessed by the number of adverse events.

Secondary Outcome Measures

Name	Time	Method
Efficacy: Fugl Meyer Upper Extremity	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.
Efficacy: Gross Grasp (Dynamometry)	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.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States