TeleRehab for Traumatic Brain Injury

Overseen By Emma Kaplan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Neurological disorder, Substance abuse, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two telerehabilitation treatments to help people with traumatic brain injury (TBI) improve the use of their affected arm and hand. The first treatment, Exergame, uses a digital game to guide arm exercises. The second, HAHE, focuses on home-based exercises based on daily activities. This trial targets individuals who have had a moderate-to-severe TBI for over a year and experience difficulty using one arm more than the other. Participants must have a smartphone, internet, and a TV at home to join. As an unphased trial, this study offers a unique opportunity to explore innovative rehabilitation methods that could enhance daily living.

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 these telerehabilitation techniques and technologies are safe?

Previous studies have examined video game therapy, such as the Exergame program, for aiding individuals with traumatic brain injury (TBI). Research has shown that these programs can enhance balance and attention without major side effects. For instance, video games in rehabilitation have improved physical and mental functions, suggesting the approach is generally well-tolerated.

Similarly, research on Home-based Arm and Hand Exercise (HAHE) programs shows promise. Studies suggest these exercises can enhance arm and hand function in TBI patients. Participants in these programs reported improvements without significant negative effects.

Both Exergame and HAHE appear safe for TBI rehabilitation, based on current evidence. However, individual experiences may vary, and it is important to consider personal health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TeleRehab approach for traumatic brain injury because it leverages technology to create personalized rehabilitation experiences at home. Unlike traditional in-person therapy, which often requires frequent visits to a clinic, both the Exergame and HAHE methods allow participants to engage in therapeutic activities remotely. This flexibility makes rehabilitation more accessible and adaptable to individual needs, potentially improving adherence and outcomes. Additionally, by incorporating real-life activities and personal preferences, these methods aim to make rehabilitation more engaging and relevant to daily life.

What evidence suggests that this trial's treatments could be effective for improving upper limb function in traumatic brain injury?

Research has shown that playing video games can enhance physical and mental abilities in people with traumatic brain injury (TBI). One study found that some participants experienced a 70% to 100% improvement in mental skills after using video games. Another study demonstrated that these games can also enhance the outcomes of both mental and physical therapy. In this trial, participants in the Exergame arm will engage in video game-based exercises designed to enhance upper limb function.

For the Home-based Arm and Hand Exercise (HAHE) program, research indicates that home exercises can help TBI patients improve hand and arm movements. In a study where participants were randomly assigned to different groups, those who performed these exercises showed significant improvements in using their upper limbs. In this trial, participants in the HAHE arm will perform exercises based on real-life activities to improve upper limb function. Additionally, remote supervision by a therapist was found to be as effective for hand function as in-person sessions. ^{1 3 4 6 7}

Who Is on the Research Team?

Peii Chen, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with chronic traumatic brain injury (TBI) who are experiencing difficulties with arm and hand functions. Specific eligibility criteria details are not provided, but typically participants must meet certain health conditions to be included.

Inclusion Criteria

Time post injury > 12 months

Moderate-to-severe TBI

One of my arms is weaker than the other and it affects how I use it.

Exclusion Criteria

Living outside of the 50-mile radius of Kessler Foundation (West Orange, NJ)

My arm's movement is very limited or I can move it normally.

I experience severe pain during movement evaluations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (virtual)

Treatment

Participants engage in 30 one-hour sessions of upper limb exercises over 6 weeks using either the HAHE or Exergame program

6 weeks

Weekly video call consultations

Follow-up

Participants are monitored for changes in upper limb function and quality of life after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Exergame
• HAHE

Trial Overview The study is testing the effectiveness of telerehabilitation techniques, including an 'Exergame' and a method called HAHE, in improving upper limb function for people with TBI. It's a preliminary step towards a larger clinical trial.

How Is the Trial Designed?

Group I: Home-based Arm and Hand Exercise (HAHE) Experimental Treatment 1 Intervention

An occupational therapist (OT) will incorporate participants' preference, goals, and current function to co-create UL exercise activities with participants. The exercise activities will be based on real-life activities that participants are familiar with. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision.

Group II: Exergame Experimental Treatment 1 Intervention

An occupational therapist (OT) will incorporate participants' preference, goals, and current function to select UL exercise activities with participants from the RehabKit program software. During the 6-week TeleRehab period, participants will complete 30 one-hour sessions of UL exercise activities, on their own without immediate supervision.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

New Jersey Commission on Brain Injury Research

Collaborator

Trials

6

Recruited

180+

Published Research Related to This Trial

A low-cost gaming station designed for pediatric arm and hand therapy was found to be highly usable by therapists, scoring 76.7 on the System Usability Scale, indicating it is practical for clinical use.

Children with cerebral palsy using the gaming station showed significant improvements in therapy goals, with notable increases in performance and satisfaction scores on the Canadian Occupational Performance Measure after 12 weeks of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Force Resistance Training in Hand Grasp and Arm Therapy: Feasibility of a Low-Cost Videogame Controller. Hernández, HA., Khan, A., Fay, L., et al.[2019]

A short-term practice with the 3D immersive videogame 'Octopus' led to significant improvements in arm-postural coordination among 13 individuals with mild-to-moderate traumatic brain injury (TBI), indicating its potential as a rehabilitation tool.

Most participants demonstrated enhanced game performance, faster arm movement times, and better precision, with 10 out of 13 showing increased arm reach and balance, suggesting effective retraining of coordination strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a 3D immersive videogame to improve arm-postural coordination in patients with TBI. Ustinova, KI., Leonard, WA., Cassavaugh, ND., et al.[2021]

The study involved 24 adolescents aged 9-18 with mild traumatic brain injuries (MTBI) and evaluated the Nintendo Wii as a tool for assessing exertion and balance in a clinical setting.

The Wii Fit Running game was found to significantly increase heart rate and caloric expenditure, suggesting it could be useful for evaluating exercise tolerance post-concussion, although balance loss during gameplay did not correlate with traditional balance assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Nintendo Wii for assessing return to activity readiness in youth with mild traumatic brain injury. DeMatteo, C., Greenspoon, D., Levac, D., et al.[2019]

The Personalized In-home eXErgames for Rehabilitation (PIXER) system is a novel 3D exergame platform that allows stroke survivors to engage in home exercise programs, showing feasibility for community-dwelling patients after stroke.

In a clinical pilot study with 10 stroke survivors over 1 month, participants demonstrated positive trends in physical functioning, with 70% completing the program and improvements noted in the Stroke Impact Scale scores, suggesting potential benefits for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized 3D exergames for in-home rehabilitation after stroke: a pilot study. Desai, K., Prabhakaran, B., Ifejika, N., et al.[2023]

A 12-week telerehabilitation program using exergaming showed significant improvements in ambulation speed and distance for individuals with multiple sclerosis, indicating its efficacy as a physical therapy alternative.

Participants reported high satisfaction with the telerehabilitation experience, with a 58.3% adherence rate, suggesting that this approach is not only effective but also well-accepted by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and outcomes of an individualized exergaming telePT program for veterans with multiple sclerosis: a pilot study. Chanpimol, S., Benson, K., Maloni, H., et al.[2022]

In a 3-month pilot study involving 3 adolescents with severe hemiplegic cerebral palsy, in-home virtual reality videogame telerehabilitation significantly improved hand function and finger range of motion, as assessed by standardized occupational therapy tests and remote measurements.

The two participants who adhered most closely to the rehabilitation regimen also showed improvements in forearm bone health, and all participants exhibited changes in brain motor circuitry activation during fMRI, indicating that the therapy not only enhanced physical function but also influenced brain activity related to movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-home virtual reality videogame telerehabilitation in adolescents with hemiplegic cerebral palsy. Golomb, MR., McDonald, BC., Warden, SJ., et al.[2022]

In a 4-week trial involving 20 patients with subacute stroke, those who participated in 'Playstation EyeToy Games' showed significantly greater improvement in self-care abilities compared to a control group, indicating enhanced upper extremity motor functioning.

While the EyeToy games improved self-care scores, there were no significant differences in the overall motor recovery stages of the hand and upper extremity between the two groups, suggesting that while the games are beneficial, they may not affect all aspects of motor recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

''Playstation eyetoy games'' improve upper extremity-related motor functioning in subacute stroke: a randomized controlled clinical trial. Yavuzer, G., Senel, A., Atay, MB., et al.[2022]

Gaming console exercise is feasible for individuals with acquired brain injury (ABI), showing high compliance (99%) and no adverse events during an 8-week trial involving 21 participants.

While the gaming console exercise did not lead to significant improvements in endurance, gait, or balance compared to usual therapy alone, it may enhance engagement in therapy, suggesting potential benefits for motivation and participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of gaming console exercise and its effect on endurance, gait and balance in people with an acquired brain injury. McClanachan, NJ., Gesch, J., Wuthapanich, N., et al.[2019]

The COCARE telerehabilitation system was well-accepted by both older adults (83% acceptance) and healthcare professionals (81% acceptance), indicating its potential as an effective alternative to traditional rehabilitation methods.

Participants reported high enjoyment levels (mean score of 73.3 out of 100) during exergame sessions, suggesting that the system is engaging, although some usability issues were identified that need to be addressed for better implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Newly Developed Exergame-Based Telerehabilitation System for Older Adults: Usability and Technology Acceptance Study. Seinsche, J., de Bruin, ED., Saibene, E., et al.[2023]

In a pilot study involving 20 stroke patients aged 33-65, both conventional balance training and multi-exergaming showed significant improvements in functional balance, with the exergaming group demonstrating particularly notable enhancements in specific tests like the Four Square Step Test and the 10 Meter Walk Test.

While both training methods were effective, the exergaming approach allowed for targeted motor control training and may offer a feasible option for independent balance training, which could be beneficial for home rehabilitation, despite the study's low statistical power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Exergames to Set Targets and Supplement the Intensified Conventional Balance Training in Patients With Stroke: A Randomized Pilot Trial. Cikajlo, I., Rudolf, M., Mainetti, R., et al.[2020]

Unsupervised use of commercial exergames at home shows promising effects on improving physical health and quality of life for adults in need of rehabilitation, with 20 studies involving 1,558 participants reviewed.

While adherence to exergaming was generally high, the quality of evidence varied, with some studies showing a high risk of bias, indicating the need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial exergames for rehabilitation of physical health and quality of life: a systematic review of randomized controlled trials with adults in unsupervised home environments. Rüth, M., Schmelzer, M., Burtniak, K., et al.[2023]

Citations

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Video game training in traumatic brain injury patients Search time showed a highly effective reduction in participant 2 (PND = 100%) and moderately effective decrease in participant 3 (PND=70%). Overall, video game ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4764786/

Digital Gaming for Improving the Functioning of People With ... Further, a systematic review concluded that video games have the potential to improve health outcomes in psychological and physical therapy [17] ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/23311908.2016.1143732

Cognitive rehabilitation of attention deficits in traumatic ... This paper investigates the utility and efficacy of a novel eight-week cognitive rehabilitation programme developed to remediate attention deficits in adults

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Gaming supports youth with acquired brain injury? A pilot ... Results indicated that interventions using the Wii and similar video game activities contributed to improvements in physical, cognitive and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03386968

Virtual Reality and Active Video Games to Improve Balance ... Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury. ClinicalTrials.gov ID NCT03386968. Sponsor Blythedale Children's ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5424286/

The effects of video game therapy on balance and attention in ... Video game therapy is an option for the management of chronic traumatic brain injury patients to ameliorate balance and attention deficits.

7. scispace.com scispace.com/pdf/using-virtual-reality-and-videogames-for-traumatic-brain-4sdsrv1j3a.pdf

using-virtual-reality-and-videogames-for-traumatic-brain- ... Conclusions: The evidence that the use of virtual reality in rehabilitation of traumatic brain injury improves motor and cognitive functionality is currently ...