Clinical trial NCT06691880: Feasibility of Video Gaming Technology for Arm Recovery Early Post-stroke
Official title: Translating SMARTS 2: the Integration of Video Gaming Technology Into Traditional Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subacute Stroke
Acute Stroke
Keywords: stroke
brain repair
recovery
video gaming
Implementation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Adherence to the protocol as assessed by session attendance
timeFrame: Immediately Post Intervention
measure: Feasibility: Efficiency (total time on task)
timeFrame: Immediately Post Intervention
measure: Feasibility: Acceptability of the intervention as assessed by the Technology Acceptance Measure
timeFrame: Post intervention up to 2 weeks
measure: Feasibility: Acceptability of the intervention as assessed by the Intrinsic Motivation Inventory
timeFrame: Post Intervention up to 2 weeks
measure: Heart rate
timeFrame: Baseline, Immediately Post-Intervention
measure: Blood pressure (mmHg)
timeFrame: Baseline, Immediately Post-Intervention
measure: Pain as assessed by Wong-Baker Faces Pain Rating Scale
timeFrame: Baseline, Immediately Post-Intervention
measure: Fatigue as assessed by Fatigue Visual Analog Scale
timeFrame: Baseline, Immediately Post-Intervention
measure: Safety as assessed by the number of adverse events
timeFrame: Baseline, Immediately Post-Intervention
Secondary outcomes:
measure: Efficacy: Fugl Meyer Upper Extremity
timeFrame: Baseline, Immediately Post-Intervention
measure: Efficacy: Gross Grasp (Dynamometry)
timeFrame: Baseline, Immediately Post-Intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mona Bahouth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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