Telerehabilitation for Stroke

Overseen By Johnson K Sun

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TRCare, Inc.

Disqualifiers: Advanced dementia, Cognitive interference, Communication deficits, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and practicality of providing extra rehab therapy to stroke patients using a new telerehabilitation system called HandyMotion. The goal is to improve arm function by enabling patients to practice therapy exercises directly from their hospital room with a TV-connected sensor system. Ideal participants are those who have experienced a stroke in the last 30 days and have noticeable, but not severe, arm weakness.

As an unphased trial, this study offers patients the chance to contribute to innovative rehabilitation methods that could enhance recovery experiences for future stroke patients.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the HandyMotion device is safe for stroke rehabilitation?

Research shows that the HandyMotion Treatment Program is generally safe for stroke recovery. In earlier studies, patients found this telerehabilitation system safe and easy to use. It allows patients to perform additional rehab exercises directly from their hospital rooms, which can enhance arm movement after a stroke.

Reports indicate that patients managed the HandyMotion system well, experiencing only a few minor side effects. This suggests the treatment did not cause serious harm for most users. Researchers have studied this type of therapy for some time, and its safety appears promising.

Although this treatment remains under study, early results suggest it could safely enhance recovery after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HandyMotion Treatment Program for stroke rehabilitation because it brings therapy directly to patients through bedside telerehabilitation. Unlike traditional stroke rehabilitation, which often requires in-person visits to a clinic, HandyMotion uses a device that lets patients interact with a rehabilitation program displayed on their TV. This approach not only makes therapy more accessible and convenient but also allows for daily, consistent therapy sessions, which are crucial for recovery. By leveraging technology, this program has the potential to enhance patient engagement and improve recovery outcomes without the need for frequent travel.

What evidence suggests that the HandyMotion device is effective for stroke rehabilitation?

Research has shown that telerehabilitation, such as the HandyMotion Treatment Program in this trial, can improve balance and mobility in stroke patients. Participants will use the HandyMotion device to perform rehab exercises in their hospital room. Studies have found that similar telerehabilitation systems effectively support therapy and education in stroke recovery. Those who have used home-based telerehabilitation have experienced improvements in their recovery. Although more research is needed, early results suggest that HandyMotion could help stroke survivors recover more effectively and quickly. ^{1 3 5 6 7}

Who Is on the Research Team?

Natalia Covarrubias-Eckardt, MD

Principal Investigator

Providence St. Jude Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke within the last 30 days, causing arm weakness but not complete paralysis. They must be able to follow instructions and participate in therapy using their arms, without major neurological or psychiatric conditions that would interfere with the study.

Inclusion Criteria

I can move my arms well enough to do therapy.

Able to follow simple instructions

Informed consent signed by the subject

Exclusion Criteria

Deficits in communication that interfere with reasonable study participation

I think my mental ability may prevent me from following game or exercise instructions.

My best eye sees worse than 20/50, even with glasses or contacts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive daily bedside telerehabilitation therapy using the HandyMotion device for 5 days per week

2 weeks

Daily sessions in hospital room

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HandyMotion Treatment Program

Trial Overview The HandyMotion Treatment Program is being tested to see if it's safe and doable for stroke patients. It's a sensor-based system connected to a TV, allowing patients to play rehab games and do exercises from their hospital room anytime during their stay.

How Is the Trial Designed?

Group I: Bedside Telerehabilitation Experimental Treatment 1 Intervention

Participants will be assigned 45-minute therapy training exercises each day for 5 days per week. Participants will use the HandyMotion device to interact with the telerehabilitation program displayed on the TV set in the patient room.

HandyMotion Treatment Program is already approved in United States for the following indications:

Approved in United States as HandyMotion Treatment Program for:

• Rehabilitation after stroke
• Improvement of arm function

Who Is Running the Clinical Trial?

TRCare, Inc.

Lead Sponsor

Trials

2

Recruited

80+

Providence St. Jude Medical Center

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Telerehabilitation programs after stroke showed equivalent or improved functional outcomes compared to traditional face-to-face therapy, particularly in motor function and mobility assessments, based on a systematic review of 13 studies and a meta-analysis of 10 trials.

Patient adherence to telerehabilitation was high, ranging from 75% to 100%, indicating that patients are willing to engage with these programs, although satisfaction levels varied and highlight the need for better standardization in therapy protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation service impact on physical function and adherence compared to face-to-face rehabilitation in patients with stroke: A systematic review and meta-analysis. Sharififar, S., Ghasemi, H., Geis, C., et al.[2023]

A scoping review of 107 studies involving 3991 participants with stroke found that safety measures during asynchronous telerehabilitation exercises are rarely reported, with only 10 studies detailing such measures.

Common safety strategies included assessing exercise locations, using seated positions, and implementing live warning systems to prevent risky exercises, highlighting the need for more comprehensive reporting in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures to ensure safety during telerehabilitation of people with stroke: A scoping review. Gutierrez-Arias, R., González-Mondaca, C., Marinkovic-Riffo, V., et al.[2023]

The REWIRE platform for autonomous telerehabilitation demonstrated safety with no adverse events reported during a 12-week study involving 15 stroke patients, indicating it is a secure option for home-based rehabilitation.

Participants showed high compliance with the program, completing an average of 71% of scheduled sessions, and reported excellent acceptance of the system, suggesting it is both effective and well-received for improving balance and gait at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system. Held, JP., Ferrer, B., Mainetti, R., et al.[2022]

Videogame-driven telerehabilitation (VGDT) is currently the most promising approach for stroke rehabilitation, showing moderate to strong evidence of efficacy in improving patient outcomes.

Further research is needed to address important factors such as system usability, cost-effectiveness, and data privacy to enhance the feasibility and implementation of VGDT in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation and emerging virtual reality approaches to stroke rehabilitation. Putrino, D.[2022]

Telerehabilitation has a small but statistically significant effect on improving balance and functional mobility in stroke survivors, based on a systematic review of 14 studies involving 594 patients.

Despite these positive findings, the overall quality of evidence is low, indicating a need for more rigorous research to confirm the effectiveness of telerehabilitation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Telerehabilitation on Balance and Functional Mobility in Patients with Stroke: A Systematic Review and Meta-Analysis. Alayat, MS., Almatrafi, NA., Almutairi, AA., et al.[2023]

Telerehabilitation (TR) applications show promise, with 71% of the 61 reviewed studies reporting successful outcomes, particularly in cardiac and neurological rehabilitation.

However, only 51% of the applications demonstrated clinically significant results, and further high-quality research is needed to establish TR as a standard practice in routine rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of benefit from telerehabilitation in routine care: a systematic review. Hailey, D., Roine, R., Ohinmaa, A., et al.[2022]

A three-month interactive telerehabilitation program for patients recovering from hip or knee replacement showed similar improvements in physical functionality and quality of life compared to traditional aftercare, with both groups increasing their distance in the 6-minute walk test.

Notably, the telerehabilitation group had a significantly higher return-to-work rate (64.6%) compared to the control group (46.2%), suggesting that this approach may enhance recovery outcomes in terms of employment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Telerehabilitation as a Supplement to Rehabilitation in Patients After Total Knee or Hip Replacement: Randomized Controlled Trial. Eichler, S., Salzwedel, A., Rabe, S., et al.[2020]

A study involving 99 post-stroke individuals showed that both robotic-assisted therapy combined with a home exercise program (HEP) and HEP alone improved upper-extremity function, indicating that both methods are effective for rehabilitation.

However, there was no significant difference in motor function improvement between the two groups, suggesting that while robotic therapy is beneficial, it may not provide additional advantages over traditional home exercise alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. Wolf, SL., Sahu, K., Bay, RC., et al.[2019]

Telerehabilitation using a virtual reality-based system significantly improved motor performance in post-stroke patients compared to traditional physical therapy, as measured by the Fugl-Meyer Upper Extremity scale.

Both telerehabilitation and traditional therapy were effective in enhancing motor function, but the telerehabilitation approach may allow for earlier hospital discharge and better resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercises for paretic upper limb after stroke: a combined virtual-reality and telemedicine approach. Piron, L., Turolla, A., Agostini, M., et al.[2022]

The TeleReh system offers an accessible telerehabilitation solution for post-stroke patients, allowing them to continue hand rehabilitation at home using a personal computer and camera, which enhances regular exercise under specialist supervision.

The system utilizes computer vision to monitor hand movements and ensure exercises are performed correctly, providing personalized feedback and progress reports, which can improve therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation approach for patients with hand impairment. Staszuk, A., Wiatrak, B., Tadeusiewicz, R., et al.[2017]

A low-cost telerehabilitation system using exergames significantly improved balance in stroke patients, with notable increases in the Berg Balance Scale and Barthel scale scores after four weeks of training.

The system demonstrated excellent usability, indicating that it is a feasible and effective complementary approach to conventional treatment for enhancing rehabilitation outcomes in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exergames and Telerehabilitation on Smartphones to Improve Balance in Stroke Patients. Burgos, PI., Lara, O., Lavado, A., et al.[2023]

Telerehabilitation can provide similar or lower costs compared to in-person rehabilitation, making it a potentially more accessible option for patients at home, as shown in a review of 35 studies.

The long-term effects of telerehabilitation on clinical outcomes and health-related quality of life are still uncertain, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of economic analyses of home-based telerehabilitation. Grigorovich, A., Xi, M., Lam, N., et al.[2023]

The Augmented Community Telerehabilitation Intervention (ACTIV) did not show a significant improvement in physical function for all participants compared to usual care, with a P-value of 0.07 in the postintervention analysis of 95 stroke patients.

However, a per-protocol analysis indicated that participants who engaged with more than 50% of the ACTIV program experienced significant improvements in physical function (P = 0.04), suggesting that higher engagement may lead to better outcomes shortly after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation After Stroke Using Readily Available Technology: A Randomized Controlled Trial. Saywell, NL., Vandal, AC., Mudge, S., et al.[2021]

Telerehabilitation utilizes communication technologies to provide effective rehabilitation services remotely, making it accessible for patients in various settings like home, school, and work.

The development of a specialized telerehabilitation system for speech-language treatment after stroke, which includes computerized therapy tasks and a touchscreen interface, enhances the effectiveness of remote therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation tools for the provision of remote speech-language treatment. Brennan, D., Georgeadis, A., Baron, C.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05625438

NCT05625438 | Telerehabilitation Early After Stroke Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10681061/

The Effectiveness of Telerehabilitation on Balance and ... Telerehabilitation may improve balance and functional mobility in stroke survivors. However, it is evident that more high-quality research is required.

3. withpower.com withpower.com/trial/phase-stroke-10-2023-3e663

Telerehabilitation for CNS Injuries What data supports the effectiveness of the HandyMotion Treatment Program, a telerehabilitation treatment for CNS injuries? Research shows that ...

4. clinconnect.io clinconnect.io/trials/NCT05625438

Telerehabilitation Early After Stroke (NCT05625438) Throughout the study, participants can expect to use the HandyMotion system to engage in therapy designed to help them recover better and faster. It's important ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5734923/

A Home-Based Telerehabilitation Program for Patients with ... This home-based system was effective in providing telerehabilitation, education, and secondary stroke prevention to participants.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06069999

NCT06069999 | Telerehabilitation Early After CNS Injury The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10080366/

Telerehabilitation Initiated Early in Post-Stroke Recovery We have demonstrated that our TR intervention previously shown to be effective in the late subacute to chronic stage, is now feasible and safe in early recovery ...