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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05441670
Other study ID # 00119657
Secondary ID 1891731-38-22
Status Recruiting
Phase N/A
First received
Last updated
Start date October 12, 2022
Est. completion date October 12, 2024

Study information

Verified date October 2023
Source Medical University of South Carolina
Contact Cindy Dodds, PhD
Phone 843-792-5731
Email doddscb@musc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 12, 2024
Est. primary completion date October 12, 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States MUSC Shawn Jenkin's Children's Hospital Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Endowment for the Arts, United States

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in scaled scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT) 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). 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)
Primary Changes in walking distance on the 6-Minute Walk Test (6WMT) 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. Pre- and post- testing before and after the 10 day intervention. Baseline day before intervention (Day 0), Day after intervention completion (Day 11)
Primary Changes in the Self-Assessment Manikin (SAM) 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. 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)
Primary Change in values of Respiratory Sinus Arrhythmia (RSA) derived from Heart Rate Variability as captured by ECG 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. 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)
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