Sponsor: MUSC
Sponsor Study ID: 103695
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
CTO #: 103695
NCT Number: NCT05441670
Phase: N/A
Protocol Type: Supportive Care
Age Group: Children
Disease Sites: Hodgkin's Lymphoma, Leukemia, other, Lymphoid Leukemia
Study Objectives: In children undergoing HCT during in-patient care, does a randomized group receiving a combination of PT plus AT have improved functional activity level outcomes of selfcare and mobility as measured by the Pediatric Evaluation of Disability Inventory Computerized Adaptive Test (PEDI CAT) and the 6-Minute Walk Test (6MWT), compared with a group receiving PT only.Do children receiving PT plus AT have different physiological (sympathetic or parasympathetic) and emotional responses to oil pastels and gouache as measured by respiratory sinus arrhythmia (RSA) derived from heart rate variability (HRV) and Self-Assessment Manikin (SAM) scores during each of the daily AT sessions. In children receiving PT plus AT, determine if there is a stronger association between the RSA values of oil pastels or gouache AT and an increased walking distance as measured by accelerometry during daily PT sessions.