NCT05441670

Art and Physical Therapy in Pediatric HCT

Active, enrolled NA Results posted Last updated 15 January 2026

What this trial tests

NA trial testing Art and Physical Therapy in Hematopoietic Stem Cell Transplantation in 18 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 October 2022

Primary endpoint
31 December 2024

31 December 2026

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	18
Start date	12 October 2022
Primary completion	31 December 2024
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Art and Physical Therapy
• Physical Therapy

Conditions studied

• Hematopoietic Stem Cell Transplantation — all drugs for Hematopoietic Stem Cell Transplantation →
• Art Therapy — all drugs for Art Therapy →
• Physical Therapy — all drugs for Physical Therapy →

Sponsor

Medical University of South Carolina

Who can join

Adults 5 to 18, any sex, with Hematopoietic Stem Cell Transplantation or Art Therapy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Scaled Scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT) Primary · Pre- and post- testing before and after the 10 day intervention. Pre-testing = Day before intervention (Day 0), Post-testing = Day after intervention completion (Day 11)

Motor function within the mobility and self-care domains of the PEDI-CAT. Scaled Scores can range from 0-100 (0=less motor function in mobility and self-care, 100=optimal motor function in mobility and self-care).

Group	Value	95% CI
Art and Physical Therapy	1.56	± 2.35
Physical Therapy	2.67	± 1.80

Changes in Walking Distance on the 6-Minute Walk Test (6WMT) Primary · Pre- and post- testing before and after the 10 day intervention. Baseline day before intervention (Day 0), Day after intervention completion (Day 11)

Community-based walking endurance measured by the 6-Minute Walk Test (6MWT). The 6MWT records the total distance walked in meters over 6 minutes. There is no upper limit other than physical capacity; typical values for healthy children range from approximately 400-700 meters depending on age and sex. Higher distances indicate better endurance and functional mobility, while lower distances indicate reduced endurance. This measure is widely validated in pediatric populations and predictive of cardiovascular fitness in childhood cancer survivors.

Group	Value	95% CI
Art and Physical Therapy	304.02	± 122.02
Physical Therapy	280.87	± 120.16

Sponsor's own description

The purpose of this study is to compare the effect of a combination of art therapy (AT) and physical therapy (PT) to PT only in children undergoing hematopoietic cell transplant (HCT). Each child will receive daily AT and PT or only PT for 5 days per week for 2 weeks. These sessions will begin approximately on day 15 following the transplant. Prior to starting the sessions and following 2-weeks of sessions, self-care and mobility skills will be measured. During each session, the following variables will be measured: heart rate variability (i.e., time between heart beats) using a small monitor on the chest (about the size of a quarter), walking distance using an accelerometer (similar to wearing a watch), and self-reported happiness and excitability. Although results cannot be guaranteed, it is expected that each group will benefit and demonstrate improvements in emotional state, self-care, and mobility skills.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.