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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Bimanual Arm Trainer VGT and MindPod Dolphin VGT for arm recovery after stroke?

Research shows that video game-based therapy can improve arm function after stroke by providing engaging and repetitive practice, which is crucial for recovery. Studies using similar gaming technologies, like the Nintendo Wii, have demonstrated improvements in arm function and manual dexterity in both stroke and cerebral palsy patients. ^{1 2 3 4 5}

Is video gaming technology for arm recovery after stroke safe for humans?

Research on video game-based therapy for conditions like cerebral palsy and stroke suggests that it is generally safe for humans, as it has been used in studies without reported safety concerns. ^{1 2 4 6 7}

How is the Bimanual Arm Trainer VGT and MindPod Dolphin VGT treatment different from other stroke recovery treatments?

The Bimanual Arm Trainer VGT and MindPod Dolphin VGT treatment is unique because it uses video gaming technology to make rehabilitation more engaging and motivating, encouraging high repetition of arm movements, which is crucial for recovery. Unlike traditional therapies, this approach leverages interactive games to enhance motor function and can be used at home, making it more accessible and adaptable to individual needs. ^{1 2 4 6 8}

Research Team

Mona Bahouth, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

I cannot follow simple one-step instructions.

I have trouble seeing the TV screen due to my vision.

Medical instability as defined by the care provider

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assistive game controller for artificial intelligence-enhanced telerehabilitation post-stroke. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Upper extremity rehabilitation using video games in cerebral palsy: a randomized clinical trial. [2022]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Computer Games as Therapy for Persons with Stroke. [2015]

5. Japan 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Commercial gaming devices for stroke upper limb rehabilitation: a systematic review. [2022]

7. New Zealand 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. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial. [2021]