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

NCT06691880 | Completed DMC

• 1 other identifier: IRB00204731
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacute Stroke; Acute Stroke

Keywords

stroke; brain repair; recovery; video gaming; Implementation

Outcome Measures

Primary Outcomes (9)

• Feasibility: Adherence to the protocol as assessed by session attendance

  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)

  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

  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

  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

  Heart rate; mean number of beats per minute.

  Baseline, Immediately Post-Intervention

• Blood pressure (mmHg)

  Systolic and diastolic blood pressure.

  Baseline, Immediately Post-Intervention

• Pain as assessed by Wong-Baker Faces Pain Rating Scale

  Pain score; (0-10) 10 indicates high level of pain

  Baseline, Immediately Post-Intervention

• Fatigue as assessed by Fatigue Visual Analog Scale

  Fatigue score; 0-10 with 10 being greater levels of fatigue

  Baseline, Immediately Post-Intervention

• Safety as assessed by the number of adverse events

  Safety as assessed by the number of adverse events.

  Baseline, Immediately Post-Intervention

Secondary Outcomes (2)

• Efficacy: Fugl Meyer Upper Extremity

  Baseline, Immediately Post-Intervention

• Efficacy: Gross Grasp (Dynamometry)

  Baseline, Immediately Post-Intervention

Study Arms (1)

Video Gaming Technology (VGT) based arm training

EXPERIMENTAL

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; Behavioral: Bimanual Arm Trainer VGT

Interventions

MindPod Dolphin VGT BEHAVIORAL

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.

Video Gaming Technology (VGT) based arm training

Bimanual Arm Trainer VGT BEHAVIORAL

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.

Video Gaming Technology (VGT) based arm training

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to Meyer 7 inpatient rehabilitation unit (CIIRP) or Zayed 12 West (12W) Brain Rescue Unit (BRU)
• 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)

You may not qualify if:

• Unable to sit upright for at least 3 minutes
• Unable to follow 1 step commands
• Vision impairment that impedes seeing the television screen
• 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 condition that limits participation in exercise
• Active seizures or epilepsy
• Inability to communicate pain status

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (9)

• Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.

  PMID: 12234086 BACKGROUND

• Prabhakaran S, Zarahn E, Riley C, Speizer A, Chong JY, Lazar RM, Marshall RS, Krakauer JW. Inter-individual variability in the capacity for motor recovery after ischemic stroke. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):64-71. doi: 10.1177/1545968307305302. Epub 2007 Aug 8.

  PMID: 17687024 BACKGROUND

• Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025.

  PMID: 24136129 BACKGROUND

• Zeiler SR, Hubbard R, Gibson EM, Zheng T, Ng K, O'Brien R, Krakauer JW. Paradoxical Motor Recovery From a First Stroke After Induction of a Second Stroke: Reopening a Postischemic Sensitive Period. Neurorehabil Neural Repair. 2016 Sep;30(8):794-800. doi: 10.1177/1545968315624783. Epub 2015 Dec 31.

  PMID: 26721868 BACKGROUND

• Stanmore E, Stubbs B, Vancampfort D, de Bruin ED, Firth J. The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials. Neurosci Biobehav Rev. 2017 Jul;78:34-43. doi: 10.1016/j.neubiorev.2017.04.011. Epub 2017 Apr 23.

  PMID: 28442405 BACKGROUND

• Gagnon MP, Orruno E, Asua J, Abdeljelil AB, Emparanza J. Using a modified technology acceptance model to evaluate healthcare professionals' adoption of a new telemonitoring system. Telemed J E Health. 2012 Jan-Feb;18(1):54-9. doi: 10.1089/tmj.2011.0066. Epub 2011 Nov 14.

  PMID: 22082108 BACKGROUND

• Aminov A, Rogers JM, Middleton S, Caeyenberghs K, Wilson PH. What do randomized controlled trials say about virtual rehabilitation in stroke? A systematic literature review and meta-analysis of upper-limb and cognitive outcomes. J Neuroeng Rehabil. 2018 Mar 27;15(1):29. doi: 10.1186/s12984-018-0370-2.

  PMID: 29587853 BACKGROUND

• Hayward KS, Brauer SG. Dose of arm activity training during acute and subacute rehabilitation post stroke: a systematic review of the literature. Clin Rehabil. 2015 Dec;29(12):1234-43. doi: 10.1177/0269215514565395. Epub 2015 Jan 7.

  PMID: 25568073 BACKGROUND

• Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.

  PMID: 22179294 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mona Bahouth, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: March 12, 2020
• Primary Completion: March 12, 2025
• Study Completion: September 1, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)