Telerehabilitation for CNS Injuries

Recruiting at 4 trial locations

Overseen By Mark Bowden, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TRCare, Inc.

Disqualifiers: Advanced dementia, Active psychosis, 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: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the HandyMotion Treatment Program, a telerehabilitation treatment for CNS injuries?

Research shows that telerehabilitation can help improve movement abilities in patients with brain injuries or strokes by allowing more practice time with therapeutic exercises. Additionally, studies indicate that telerehabilitation is feasible and can be effectively monitored remotely, even when integrated with virtual reality, without negatively impacting patient performance. ^{1 2 3 4 5}

Is telerehabilitation safe for humans?

Research indicates that telerehabilitation, including systems using virtual reality, is generally safe for humans, with no reported side effects in studies involving stroke patients. However, more detailed and high-quality studies are needed to confirm its safety across different conditions. ^{6 7 8 9 10}

How is the HandyMotion Treatment Program different from other treatments for CNS injuries?

The HandyMotion Treatment Program is unique because it uses telerehabilitation, which allows patients to receive rehabilitation services remotely through technology, making it accessible for those who may not have easy access to traditional in-person therapy. This approach can be particularly beneficial for individuals in areas with limited healthcare resources, as it provides continuous care and monitoring at home. ^{3 4 11 12 13}

Research Team

Michael Su, MD

Principal Investigator

California Rehabilitation Institute

Eligibility Criteria

This trial is for adults over 18 who've had a stroke, traumatic brain injury (TBI), or spinal cord injury (SCI) within the last 90 days. They should be able to follow simple instructions and have enough arm movement to use the HandyMotion device. People with severe neurological/psychiatric diseases, significant communication deficits, poor vision, or shoulder pain that limits therapy won't qualify.

Inclusion Criteria

I had a stroke confirmed by scans, caused by a clot or bleed.

I have a traumatic brain injury with a cognitive function score of at least 6.

I have an incomplete spinal cord injury in my neck area.

Exclusion Criteria

Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises

I do not have a severe mental health or neurological condition that would prevent me from participating.

My shoulder pain may limit my ability to complete the therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive daily bedside telerehabilitation therapy using the HandyMotion device for up to 4 weeks or until discharge

4 weeks

Daily sessions (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HandyMotion Treatment Program

Trial Overview The study tests the HandyMotion Treatment Program's safety and feasibility as an extra rehabilitation method for improving arm function in patients with recent CNS injuries. It uses telerehabilitation technology that allows patients to practice rehab exercises via their TV in hospital rooms.

Participant Groups

Group I: TR Bedside Telerehabilitation Experimental Treatment 1 Intervention

Participants will be assigned 45-minutes of therapy training exercises each day for 7 days a week up to 4 weeks or until discharge. 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+

California Rehabilitation Institute

Collaborator

Trials

2

Recruited

70+

Findings from Research

The Jerusalem TeleRehabilitation System (JTRS) allows brain injury or stroke survivors to practice therapeutic exercises more extensively through a combination of supervised and independent sessions, enhancing their movement abilities.

JTRS offers unique features such as real-time monitoring and adaptive exercise difficulty, making it user-friendly and effective for both patients and therapists, while also contributing to a central database for ongoing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Jerusalem TeleRehabilitation System, a new low-cost, haptic rehabilitation approach. Sugarman, H., Dayan, E., Weisel-Eichler, A., et al.[2006]

This systematic review aims to assess how telerehabilitation can alleviate the physical and mental burdens faced by caregivers of patients with neurological disorders, focusing on factors like stress, pain, and overall quality of life.

By evaluating various clinical trials without restrictions on publication date or language, the review seeks to provide comprehensive insights into the effectiveness of remote health services in improving caregivers' well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of physiotherapy with telerehabilitation on caregivers of patients with neurological disorders: A systematic review protocol. Silva, EMGSE., de Melo, LP., de Souza, AA., et al.[2022]

The telerehabilitation program in Nepal, involving 97 participants with spinal cord injury (SCI) or acquired brain injury (ABI), showed significant improvements in functional independence, mental health, and quality of life after remote assessments and interventions.

Participants found the program acceptable, appreciating the regular contact with multidisciplinary team professionals and the convenience of avoiding costly travel for rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TEleRehabilitation Nepal (TERN) for People With Spinal Cord Injury and Acquired Brain Injury: A Feasibility Study. Dhakal, R., Baniya, M., Solomon, RM., et al.[2022]

Telerehabilitation showed a significant improvement in functional scores for patients with spinal cord injury at the Italian site, with the telemedicine group achieving better results in activities like grooming and dressing compared to standard care.

Patients receiving telerehabilitation reported higher satisfaction with their care across all sites, suggesting that this approach may enhance the overall patient experience post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and clinical outcomes of telemedicine in patients with spinal cord injury. Dallolio, L., Menarini, M., China, S., et al.[2019]

A study involving six individuals post-stroke showed that a telerehabilitation application integrated with virtual reality (VR) maintained patient performance during a four-week training program, even when the therapist was remote in the final week.

Technical assessments indicated that the system's communication was effective, with suitable bandwidth and low lag, supporting the feasibility of remote VR-based rehabilitation without negatively impacting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical and patient performance using a virtual reality-integrated telerehabilitation system: preliminary finding. Deutsch, JE., Lewis, JA., Burdea, G.[2016]

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]

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]

Telerehabilitation is an active therapeutic approach that goes beyond traditional telemedicine by providing interactive treatment options, primarily utilized by non-medical professionals like physiotherapists and psychologists.

The Virtual Ambulance model in the Czech Republic exemplifies effective telerehabilitation, offering comprehensive services across various rehabilitation fields while ensuring secure communication through locally developed platforms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitisation and telehealth - Telemedicine in rehabilitation in the Czech environment. Pětioký, J., Hoidekrová, K., Lippertová, MG.[2022]

A new telerehabilitation system using VR technology was developed to help stroke patients improve their upper and lower limb function and balance, showing effectiveness in reducing training time for participants with motor paralysis.

The system was safe, with no reported side effects, and demonstrated that the joint angles of disabled participants improved over time, approaching those of healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a new telerehabilitation system based on VR technology using multisensory feedback for patients with stroke. Kato, N., Tanaka, T., Sugihara, S., et al.[2020]

Telerehabilitation utilizes digital technologies to deliver a wide range of rehabilitation services, including evaluation, monitoring, and education, making it accessible across various patient populations and settings such as homes and clinics.

The guidelines developed by the American Telemedicine Association aim to help practitioners provide effective and secure telerehabilitation services based on client needs and current evidence, promoting the development of discipline-specific standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Telemedicine Association's Principles for Delivering Telerehabilitation Services. Richmond, T., Peterson, C., Cason, J., et al.[2022]

Telerehabilitation (TR) significantly improved function, quality of life, kinesiophobia, and exercise adherence in individuals with chronic neck pain (CNP) compared to standard rehabilitation (SR) over an 8-week period with 40 participants.

While TR did not show superior results in pain reduction compared to SR, it resulted in high satisfaction and usability among participants, indicating a positive reception of the telerehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise and education combination via telerehabilitation in patients with chronic neck pain: A randomized controlled trial. Özden, F., Özkeskin, M., Tümtürk, İ., et al.[2023]

Telerehabilitation effectively delivers a wide range of rehabilitation services through technology, allowing for assessment, monitoring, and intervention across various settings such as homes, clinics, and schools.

This document serves as a guideline for practitioners to ensure that telerehabilitation services are safe, effective, and tailored to client needs, promoting the development of discipline-specific standards in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A blueprint for telerehabilitation guidelines. Brennan, D., Tindall, L., Theodoros, D., et al.[2022]

Telerehabilitation is a promising approach for stroke recovery, allowing for continuous monitoring of patients' motion activities at home, which is crucial for effective rehabilitation after the initial hospital care.

Preliminary clinical trials indicate that this remote therapy not only enhances rehabilitation outcomes but also achieves high satisfaction levels among both patients and therapists, suggesting its potential for broader application in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the integration of novel wearable step-counters in gait telerehabilitation after stroke. Giansanti, D., Tiberi, Y., Silvestri, G., et al.[2016]

References

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

The Jerusalem TeleRehabilitation System, a new low-cost, haptic rehabilitation approach. [2006]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of physiotherapy with telerehabilitation on caregivers of patients with neurological disorders: A systematic review protocol. [2022]

3. England pubmed.ncbi.nlm.nih.gov

TEleRehabilitation Nepal (TERN) for People With Spinal Cord Injury and Acquired Brain Injury: A Feasibility Study. [2022]

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

Functional and clinical outcomes of telemedicine in patients with spinal cord injury. [2019]

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

Technical and patient performance using a virtual reality-integrated telerehabilitation system: preliminary finding. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Evidence of benefit from telerehabilitation in routine care: a systematic review. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Autonomous rehabilitation at stroke patients home for balance and gait: safety, usability and compliance of a virtual reality system. [2022]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

Digitisation and telehealth - Telemedicine in rehabilitation in the Czech environment. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

Development and evaluation of a new telerehabilitation system based on VR technology using multisensory feedback for patients with stroke. [2020]

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

American Telemedicine Association's Principles for Delivering Telerehabilitation Services. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

The effect of exercise and education combination via telerehabilitation in patients with chronic neck pain: A randomized controlled trial. [2023]

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

A blueprint for telerehabilitation guidelines. [2022]

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

Toward the integration of novel wearable step-counters in gait telerehabilitation after stroke. [2016]