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Active, Not Recruiting

NCT Number: NCT05441670

Art and Physical Therapy in Pediatric HCT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hematopoietic Stem Cell Transplantation Art Therapy Physical Therapy

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUSC Shawn Jenkin's Children's Hospital

Charleston, South Carolina, 29425, United States

About this study

This quantitative randomized clinical trial will examine the effect of a collaborative art therapy (AT) and physical therapy (PT) intervention as compared to a PT only intervention in children undergoing a hematopoietic cell transplant. We hypothesize that physiological, emotional, selfcare, and mobility as measured by heart rate variability, Self-Assessment Manikin, walking distance and steps, and Pediatric Disability Inventory Computerized Adapted Test will demonstrate greater improvement for the AT and PT group as well as identify media that more effectively impact these physiological and health outcomes. Findings from this project may provide scientific evidence for increasing the uptake of AT and PT in children undergoing HCT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between ages 5 to 18
  • Clinical Diagnosis of hematological disease
  • Undergoing Hematopoietic Cell Transplantation (HCT)
  • Within the inpatient hospital treatment phase of HCT

Exclusion criteria

  • Less than age 5
  • Older than age 18
  • Central nervous system impairments (e.g., cerebral palsy)
  • Genetic diseases (e.g., Down syndrome)
  • Cognitive impairment

Treatment and study plan

Art and Physical Therapy

Behavioral

45 minutes of Art Therapy followed by 30 minutes of Physical Therapy, Monday through Friday for 2 weeks

Physical Therapy

Behavioral

30 minutes of Physical Therapy, Monday through Friday for 2 weeks

Primary outcomes

  1. Changes in Scaled Scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT)

    Time frame: 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).

  2. Changes in Walking Distance on the 6-Minute Walk Test (6WMT)

    Time frame: 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.

Secondary outcomes

  1. Changes in the Self-Assessment Manikin (SAM)

    Time frame: Collected daily at the beginning and end of each treatment session over the 10-day intervention period. (Art and physical therapy group treatment duration = 75min, physical therapy group treatment duration = 30min)

    A non-verbal pictorial assessment technique that directly measures the valence, arousal, and dominance associated with a person's affective reaction to a wide variety of stimuli. Each item is scored on a Likert scale ranging from 1 to 5. Valence is rated from 1(unpleasant) to 5 (pleasant) and it is expected that valence scores will increase following each intervention session. Arousal is rated from 1(calm) to 5 (excited), it is expected that arousal scores will decrease following each intervention session. Dominance is rated from 1(independent) to 5 (dependence), and it is expected that dominance scores will decrease following each intervention session.

  2. Respiratory Sinus Arrhythmia

    Time frame: Collected daily with continuous monitoring throughout the duration of the treatment session over the 10-day intervention period. (Art and physical therapy group treatment duration = 75min, physical therapy group treatment duration = 30min)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Endowment for the Arts, United States

Registry information

Official study title

The Effect of a Collaborative Art Therapy and Physical Therapy Intervention on Children Undergoing a Hematopoietic Cell Transplant (HCT): a Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jul 1, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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