Video Gaming Technology for Arm Recovery After Stroke

(SMARTER Trial)

Overseen By Sandra Deluzio, MS, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Vision impairment, Heart condition, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Duration of hospital stay

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether video game technology, specifically the Bimanual Arm Trainer VGT and MindPod Dolphin VGT, can aid in recovering arm movement after a stroke. The study incorporates fun and engaging video games designed to improve arm function. Participants will use the games alongside their regular therapy to determine if early use is safe and beneficial. Individuals with one-sided arm weakness after a stroke who can sit up and follow simple instructions may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to advancing stroke rehabilitation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this video gaming technology is safe for arm recovery after stroke?

In a previous study, researchers examined the safety of using video games for arm rehabilitation after a stroke. They found that technologies like the Bimanual Arm Trainer and MindPod Dolphin are generally safe and well-tolerated. The study aimed to determine if patients could handle an extra hour of this therapy without problems. Results showed that most patients completed the sessions without major issues.

During the study, researchers monitored patients' vital signs, such as blood pressure and heart rate, to ensure a positive response to the therapy. Patients also reported their levels of pain and tiredness. No significant adverse events, such as dangerous changes in vital signs or pain requiring therapy cessation, were commonly reported.

While these findings are promising, the study primarily focused on safety and feasibility. This means researchers assessed whether the therapy could be safely added to usual stroke recovery treatments. The technology is still under study, but it appears safe for patients to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using video gaming technology for arm recovery after a stroke because it offers an engaging and interactive way to rehabilitate. Unlike traditional therapies that often involve repetitive and monotonous exercises, video gaming technology like the Bimanual Arm Trainer VGT and MindPod Dolphin VGT combines fun and motivation with therapeutic exercises, potentially improving patient adherence and outcomes. These treatments also allow for real-time monitoring of physiological responses, which can provide immediate feedback and ensure the safety and customization of therapy sessions. This innovative approach could make rehabilitation more appealing and effective, helping patients regain arm function more enjoyably and efficiently.

What evidence suggests that video gaming technology is effective for arm recovery after stroke?

This trial will compare two video gaming technologies for arm recovery after stroke: the Bimanual Arm Trainer VGT and the MindPod Dolphin VGT. Studies have shown that video gaming technology can help stroke patients regain arm movement. The Bimanual Arm Trainer VGT uses video games to make therapy more engaging, improving arm function by encouraging the use of both arms and helping the brain relearn movement. Research on the MindPod Dolphin VGT has shown promising results, with improvements in motor skills for stroke patients. This system uses virtual reality to create an immersive and motivating therapy experience. Both technologies aim to make rehabilitation fun and effective, potentially speeding up recovery after a stroke. Participants in this trial will be allocated to either the Bimanual Arm Trainer VGT or the MindPod Dolphin VGT based on the severity of their arm impairment. ^{1 5 6 7 8}

Who Is on the Research Team?

Mona Bahouth, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals in the early stages of stroke recovery who are looking to improve arm function. It's exploring if using video game technology in a clinic setting can help with rehabilitation. Participants should be able to attend outpatient therapy sessions and use the gaming devices.

Inclusion Criteria

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

I have weakness in one arm that wasn't there before.

Exclusion Criteria

Medical instability as defined by the care provider

My heart condition limits my ability to exercise.

I cannot follow simple one-step instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive up to 60 minutes of video-game-based arm training 4-5 days per week in addition to standard rehabilitation therapy

Duration of hospital stay

4-5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bimanual Arm Trainer VGT
• MindPod Dolphin VGT

Trial Overview The study tests two types of video game technologies: MindPod Dolphin and Bimanual Arm Trainer, which are designed to aid arm recovery post-stroke. These involve robotics and aim to make therapy engaging while encouraging repetitive movements that benefit recovery.

How Is the Trial Designed?

Group I: Video Gaming Technology (VGT) based arm training Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

The BrightBrainer™ Grasp (BBG) is an innovative therapeutic game controller that uses AI to adapt to the specific arm and hand impairments of post-stroke patients, enhancing rehabilitation outcomes through engaging telerehabilitation.

A usability study with healthy individuals demonstrated the effectiveness of the BBG's design and its integration with therapeutic games, suggesting promising implications for future trials in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistive game controller for artificial intelligence-enhanced telerehabilitation post-stroke. Burdea, G., Kim, N., Polistico, K., et al.[2023]

In a study involving 240 stroke survivors, using the Nintendo Wii Sports™ for rehabilitation did not significantly improve arm function compared to traditional arm exercises after six weeks.

The Wii™ was well tolerated with no serious adverse events reported, but it was more expensive than standard arm exercises, suggesting it may not be a cost-effective option for home-based rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the use of Nintendo Wii SportsTM improve arm function? Trial of WiiTM in Stroke: a randomized controlled trial and economics analysis. Adie, K., Schofield, C., Berrow, M., et al.[2021]

In a study involving 30 patients with cerebral palsy, video game-based therapy (VGBT) using Nintendo® Wii and Leap Motion Controller games showed superior improvements in manual dexterity compared to traditional neurodevelopmental therapy (NDT) after 8 weeks of treatment.

Both therapies resulted in significant enhancements in grip strength and functional ability, but VGBT was particularly effective in improving manual dexterity as measured by the Minnesota Manual Dexterity Test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity rehabilitation using video games in cerebral palsy: a randomized clinical trial. Avcil, E., Tarakci, D., Arman, N., et al.[2022]

In a study involving 51 patients recovering from a stroke, video game-based rehabilitation showed a significant improvement in gross grasping function (measured by the Box and Block Test) compared to conventional rehabilitation, especially when started within the first month after the stroke.

Overall, while there were no significant long-term differences in upper limb recovery between video games and conventional therapy, video gaming proved to be more effective for patients who began treatment within 30 days post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial. Laffont, I., Froger, J., Jourdan, C., et al.[2021]

The TWIST trial is a randomized controlled trial involving 240 stroke patients, aiming to assess the feasibility and effectiveness of using Nintendo Wii Sports™ for improving arm function compared to standard rehabilitation exercises.

The primary outcome will measure changes in arm function after 6 weeks, while secondary outcomes will evaluate occupational performance, quality of life, and cost-effectiveness, making it a comprehensive study on the potential benefits of gaming in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the use of Nintendo Wii Sports™ improve arm function and is it acceptable to patients after stroke? Publication of the Protocol of the Trial of Wii™ in Stroke - TWIST. Adie, K., Schofield, C., Berrow, M., et al.[2022]

In a study involving 30 chronic stroke patients with hemiparesis, both game-based virtual reality movement therapy and mental practice led to significant improvements in upper extremity function, as measured by various assessments.

The combination of virtual reality movement therapy and mental practice resulted in greater improvements compared to virtual reality therapy alone, highlighting the added benefit of mental practice in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of game-based virtual reality movement therapy plus mental practice on upper extremity function in chronic stroke patients with hemiparesis: a randomized controlled trial. Park, JH., Park, JH.[2022]

Using the Microsoft Kinect and FAAST software, stroke patients were able to engage in upper extremity movements while playing video games, achieving an average of 34 repetitions in just five minutes, which is crucial for motor recovery.

Participants reported high satisfaction levels, indicating that this gaming approach could serve as an effective and motivating supplement to traditional stroke therapy, potentially enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer Games as Therapy for Persons with Stroke. Lauterbach, SA., Foreman, MH., Engsberg, JR.[2015]

An integrative systematic review of 19 studies involving 215 patients found that using commercial gaming devices for stroke rehabilitation can provide enjoyable and tolerable high-intensity practice for upper limb movements, with patients able to engage for up to 180 minutes per week without significant adverse effects.

While there was a noted trend towards improvement in upper limb function, the evidence is still limited and lacks high-quality studies to draw definitive conclusions about the impact on daily living activities or overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial gaming devices for stroke upper limb rehabilitation: a systematic review. Thomson, K., Pollock, A., Bugge, C., et al.[2022]

Citations

1. withpower.com withpower.com/trial/video-gaming-technology-for-arm-recovery-after-stroke-d52c3

Video Gaming Technology for Arm Recovery After Stroke The Bimanual Arm Trainer VGT and MindPod Dolphin VGT treatment is unique because it uses video gaming technology to make rehabilitation more engaging and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415726/

Feasibility of At-Home Hand Arm Bimanual Intensive ... This single-participant case study examines the feasibility of using custom virtual reality (VR) gaming software in the home environment for low-dose Hand Arm ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421001178

Effectiveness of an intensive, functional, gamified ... Rehabilitation provided with the ArmAble™ device, if found effective, can be used from the early stages post-stroke to provide intensive, repetitive, gamified ...

4. research.aota.org research.aota.org/ajot/article/78/6/7806205130/25965/Bimanual-Arm-Trainer-Versus-Traditional

Bimanual Arm Trainer Versus Traditional Occupational ... The Bimanual Arm Trainer (BAT) is a novel device that can be used in occupational therapy to improve arm function among stroke patients.

5. mirroredmotionworks.com mirroredmotionworks.com/documentation/

Bimanual Arm Trainer Research & Documentation | MMW Mirror therapy facilitates recovery. · 2. Bimanual therapy engages both sides of the body and brain in regaining movement. · 3. Video gaming increases motivation ...

6. trialx.com trialx.com/clinical-trials/listings/302451/feasibility-of-video-gaming-technology-for-arm-recovery-early-post-stroke/

Feasibility of Video Gaming Technology for Arm Recovery Early ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265130/

Upper limb robotic rehabilitation following stroke: a systematic ... The results suggest that robotic rehabilitation does not result in clinically meaningful improvement in either upper limb capacity or ADL performance.

8. researchgate.net researchgate.net/publication/354969155_Safety_and_Feasibility_of_Integrating_Video_Gaming_Technology_in_Acute_Early_Stroke_Recovery

Safety and Feasibility of Integrating Video Gaming Technology in ... Research Objectives This study aims to examine the safety and feasibility of implementing an additional hour of time-on-task upper limb training using video ...