Virtual Rehabilitation for Post Bone Marrow Transplant Recovery

Overseen By Muna Qayed, MD, MsCR

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Physical impediment, Non-English-speaking

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

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Chronic GVHD (cGVHD) is a major cause of illness in patients who undergo hematopoietic transplantation (HCT). GVHD can affect any organ in the body, can require several years of treatment, and can impact the quality of life (QoL). Physical activity and exercise have been shown to enhance fitness and improve QoL in chronic illnesses including GVHD, however, patients often have barriers to attending sessions including distance, risk of infection, and physical therapists' lack of experience with pediatric patients. The team's goal is to assess whether a virtual rehabilitation program in children post-HCT (including children with chronic GVHD) is feasible and whether its implementation will improve physical functioning and QoL. Patients between the ages of 8 and 23 years who are at least one hundred days post-HCT will be eligible for participation. Patients will have an assessment by a pediatric physical therapist at the time of study entry, at the end of the rehabilitation program, and approximately 3 months later. They will be supplied with some exercise equipment (such as dumbbells and resistance bands). Patients will have twice weekly half-hour one-on-one online sessions with the physical therapist for 12 weeks. Patients will be recruited through the bone marrow transplant clinic.

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

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with your doctor.

Is virtual rehabilitation generally safe for humans?

Research on virtual rehabilitation, including telerehabilitation and virtual reality systems, suggests it is generally safe for use in humans. However, safety concerns exist when patients exercise without direct supervision, highlighting the need for careful implementation and monitoring. ^{1 2 3 4 5}

How is the Virtual Rehabilitation treatment different from other treatments for post bone marrow transplant recovery?

Virtual Rehabilitation is unique because it uses online platforms to deliver physical therapy and rehabilitation remotely, allowing patients to recover at home with ongoing support from clinicians. This approach can overcome barriers to accessing traditional in-person rehabilitation services, making it more convenient and accessible for patients. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Virtual Rehabilitation for Post Bone Marrow Transplant Recovery?

Research shows that telehealth-based rehabilitation, which includes virtual rehabilitation, can improve disability outcomes in pediatric cancer survivors. Additionally, virtual reality-integrated telerehabilitation has been found feasible and effective for remote monitoring without negatively affecting patient performance, suggesting potential benefits for post bone marrow transplant recovery. ^{1 5 9 10 11}

Who Is on the Research Team?

Muna Qayed, MD, MsCR

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 8-21 who are at least 100 days post bone marrow transplant. They should be cleared for exercise, have internet access, and a device to participate in virtual rehab sessions. Kids under 14 need a caregiver's help during exercises. Non-English speakers and those with physical impediments to exercise cannot join.

Inclusion Criteria

I am between 8 and 21 years old and had a bone marrow transplant over 100 days ago.

Patients should have access to devices and a reliable internet connection

I am between 8-14 years old and have a caregiver to help me with my exercises.

Exclusion Criteria

Any physical impediment to exercise as evaluated by the treating physician

Non-English speaking patients (due to a lack of available interpreters through the telemedicine platform)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a virtual rehabilitation program with twice weekly half-hour online sessions for 12 weeks

12 weeks

24 virtual sessions

Follow-up

Participants are monitored for changes in physical functioning and quality of life after the rehabilitation program

4 weeks

1 visit (in-person) at the end of the program and approximately 3 months later

Long-term follow-up

Assessment of feasibility and adherence rate of the rehabilitation program over an extended period

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Rehabilitation

Trial Overview The study tests if a virtual rehabilitation program can improve physical function and quality of life in pediatric patients after hematopoietic transplantation (HCT), including those with chronic GVHD. It involves twice-weekly online sessions with a therapist over three months, plus assessments.

How Is the Trial Designed?

Group I: Virtual exercise and rehabilitation program Experimental Treatment 1 Intervention

Trial of exercise and rehabilitation program delivered via a virtual platform for patients undergoing HCT at Children's Healthcare of Atlanta.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Published Research Related to This Trial

Telehealth-based rehabilitation interventions show promise in improving disability outcomes for pediatric cancer survivors, with nine unique interventions identified, including methods like telephone, mobile health apps, and videoconferencing.

Three of the studies reviewed reported statistically and clinically significant improvements, highlighting the potential effectiveness of telehealth in this area, though more robust trials are needed to establish best practices and consistent outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Telehealth-Based Pediatric Cancer Rehabilitation Interventions on Disability. Skiba, MB., Wells, SJ., Brick, R., et al.[2023]

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]

Virtual and augmented reality environments are being effectively used for rehabilitation, helping individuals with various impairments, such as balance and attention, especially in children with brain injuries.

The shift from commercial gaming systems to specialized rehabilitation technologies indicates a growing trend in using advanced virtual reality and motion tracking to enhance therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Rehabilitation with Children: Challenges for Clinical Adoption [From the Field]. Glegg, S.[2018]

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]

During the first 5 months of the COVID-19 pandemic, ALYN-Pediatric Rehabilitation Hospital successfully provided online rehabilitation services to 147 young people, delivering a total of 2392 therapy sessions across various disciplines, which were well-received by patients, parents, and therapists.

The study suggests that a hybrid model combining in-person and online therapy could be the most effective approach for young people with chronic disabilities, as the majority found tele-rehabilitation beneficial and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned during a Naturalistic Study of Online Treatment for Pediatric Rehabilitation. Gefen, N., Steinhart, S., Beeri, M., et al.[2021]

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]

A systematic review of six randomized controlled trials involving 368 patients found that telerehabilitation for shoulder pain shows no significant difference in effectiveness compared to in-person physical therapy or home-based exercise programs.

However, telerehabilitation was found to be more effective than providing advice alone, significantly improving both shoulder pain and disability, although the overall evidence quality was very low to low, indicating caution in making strong recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. Gava, V., Ribeiro, LP., Barreto, RPG., et al.[2022]

Advancements in virtual reality (VR) technology are making it more accessible for rehabilitation, allowing for controlled environments that can target various physical, psychological, and cognitive issues.

The potential for Internet-based VR applications could revolutionize home-based therapy, increasing patient engagement and improving outcomes, although several challenges must be addressed before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of using virtual reality in telerehabilitation. Rizzo, AA., Strickland, D., Bouchard, S.[2004]

The CaRE-4-alloBMT program, a 6-month rehabilitation initiative for patients undergoing allogeneic blood and marrow transplantation, includes personalized exercise plans and remote monitoring, aiming to improve patient outcomes and support during recovery.

This phase II randomized controlled trial will assess the feasibility and acceptability of the program in 80 patients, providing valuable insights for future larger-scale studies on rehabilitation after alloBMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial. Tam, S., Kumar, R., Lopez, P., et al.[2023]

A study involving 58 patients who underwent stem cell transplantation found no significant difference in physical functioning or quality of life between those who participated in a healthcare professional-led rehabilitation program and those who managed their rehabilitation independently.

Both rehabilitation methods were equally effective, suggesting that a flexible approach where patients can choose their rehabilitation options may be beneficial in meeting individual needs after stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation programme after stem cell transplantation: randomized controlled trial. Bird, L., Arthur, A., Niblock, T., et al.[2019]

The VirTele intervention, a remote rehabilitation program using virtual reality exergames and telerehabilitation, showed promise in empowering stroke survivors to improve their upper extremity deficits at home, with a structured program involving 30 minutes of exergame use five times a week and regular clinician support.

Key factors influencing the use of VirTele included the perceived usefulness of the technology, ease of use, family support, and effective communication, highlighting the importance of motivational techniques used by clinicians to enhance adherence and engagement in rehabilitation activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned From Clinicians and Stroke Survivors About Using Telerehabilitation Combined With Exergames: Multiple Case Study. Allegue, DR., Sweet, SN., Higgins, J., et al.[2022]

Citations

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

A Systematic Review of Telehealth-Based Pediatric Cancer Rehabilitation Interventions on Disability. [2023]

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

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

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

Virtual Rehabilitation with Children: Challenges for Clinical Adoption [From the Field]. [2018]

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Lessons Learned during a Naturalistic Study of Online Treatment for Pediatric Rehabilitation. [2021]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. [2022]

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

The challenge of using virtual reality in telerehabilitation. [2004]

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

A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Rehabilitation programme after stem cell transplantation: randomized controlled trial. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Lessons Learned From Clinicians and Stroke Survivors About Using Telerehabilitation Combined With Exergames: Multiple Case Study. [2022]