Art and Physical Therapy in Pediatric HCT

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: August 1, 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Art and Physical Therapy
  • Active Comparator: Physical Therapy

Clinical Trial Outcome Measures

Primary Measures

  • 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).
  • 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 with a mean distance of 618 meters for typically developing children (Ulrich, 2013). It is anticipated that children undergoing HCT will have lower values compared to typically developing children, however it is expected that there will be improvements in walking distance from pre-test to post-test. Lower distances accomplished during the walk test reflect less endurance and higher distances reflect greater endurance.
  • 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.
  • Change in values of Respiratory Sinus Arrhythmia (RSA) derived from Heart Rate Variability as captured by ECG
    • 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)
    • This is a continuous measure that is reflective of the autonomic nervous system. Lower RSA indicate less homeostasis and higher values indicate greater homeostasis. It is expected that RSA values will be higher at the end of the session as compared to the beginning of the session.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Collaborator
    • National Endowment for the Arts, United States
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cindy Dodds, Associate Professor – Medical University of South Carolina
  • Overall Contact(s)
    • Cindy Dodds, PhD, 843-792-5731, doddscb@musc.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.