Actively Recruiting

Phase Not Applicable
Age: 8Years - 23Years
All Genders
ID05943964

A Pilot Study of Virtual Rehabilitation After Hematopoietic Cell Transplantation

Led by Emory University · Updated on 2025-09-19

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

I

Incyte Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic graft-versus-host disease (cGVHD) is a common complication that affects patients after hematopoietic cell transplantation (HCT), impacting many organs and requiring long-term treatment that can reduce quality of life. Researchers are evaluating a virtual rehabilitation program designed for children and young adults aged 8 to 23 years who are at least 100 days post-HCT, including those with cGVHD, to see if it is feasible and if it can improve physical functioning and quality of life. This pilot study is led by Emory University and focuses on overcoming barriers to rehabilitation such as travel distance, infection risk, and limited pediatric expertise. The program involves participants receiving exercise equipment like dumbbells and resistance bands and engaging in twice-weekly, 30-minute one-on-one online sessions with pediatric physical therapists for 12 weeks. These sessions include aerobic and stretching exercises tailored to patient needs, including specific stretches for joints with limited range of motion. The rehabilitation is delivered through a telemedicine platform commonly used in the blood and marrow transplant clinic, and adherence is supported during monthly clinic visits. Participants will undergo assessments by a pediatric physical therapist at the start, end, and approximately three months after the program to evaluate physical function and quality of life improvements. The main outcomes measured are adherence to the program during the 12-week intervention and the program's feasibility over up to four years. Secondary measures include changes in a 6-minute walk test from baseline to the end of the program. The total participation involves regular virtual sessions and follow-up assessments to monitor progress and safety.

CONDITIONS

Brief Title

Virtual Rehabilitation in HCT

Who Can Participate

Age: 8Years - 23Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Recipients between the ages of 8 and 23 years who are at least 100 days post allogeneic hematopoietic cell transplantation.
  • Patients aged 8 to 14 years must have a caregiver willing to assist with exercises during sessions.
  • Patients must have access to a device and reliable internet connection.
  • Patients must be cleared for exercise by their physician.
  • Eligibility is regardless of underlying diagnosis, preparative regimen, or graft source.
Not Eligible

You will not qualify if you...

  • Any physical condition preventing exercise as determined by the treating physician.
  • Non-English-speaking patients due to lack of interpreter services on the telemedicine platform.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Outpatient Treatment

Duration - 12 weeks

Participants take part in a virtual exercise and rehabilitation program focusing on aerobic and stretching exercises supervised by physical therapists.

Two 30-minute virtual sessions per week

Follow-up

Duration - Up to 4 years

Participants are monitored for adherence and feasibility of the rehabilitation program, with assessments continuing up to 4 years.

Monthly standard clinic visits for adherence encouragement and assessments

Trial Site Locations

Total: 1 location

1

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Actively Recruiting

Loading map...

Research Team

M

Muna Qayed, MD, MsCR

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

Similar Trials

Intervention Strategies to Improve Cognitive Functioning in ...

Cognitive Impairment

Actively Recruiting

1 location

Early Use of Tacrolimus in HLA-Mismatched Haploidentical All...

Hematologic Disease and Disorders

Actively Recruiting

1 location

Feasibility and Acceptability of Primary Palliative Care Int...

Hematopoietic Cell Transplant

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here