Art and Physical Therapy in Pediatric HCT

NCT05441670 | Active Not Recruiting Results

• 2 other identifiers: 001196571891731-38-22
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic Stem Cell Transplantation; Art Therapy; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• 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)

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

  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.

  Pre- and post- testing before and after the 10 day intervention. Baseline day before intervention (Day 0), Day after intervention completion (Day 11)

Secondary Outcomes (2)

• Changes in the Self-Assessment Manikin (SAM)

  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)

• Respiratory Sinus Arrhythmia

  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)

Study Arms (2)

Art and Physical Therapy

EXPERIMENTAL

45-minutes of AT immediately followed by 30 minutes of PT Monday through Friday for 2 weeks. Targeting media that offer fluidity and tactile input, two were chosen for this study: oil pastels week 1 and gouache without brush during week 2.

Behavioral: Art and Physical Therapy

Physical Therapy

ACTIVE COMPARATOR

PT Monday through Friday for 2 weeks.

Behavioral: Physical Therapy

Interventions

Art and Physical Therapy BEHAVIORAL

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

Art and Physical Therapy

Physical Therapy BEHAVIORAL

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

Physical Therapy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Endowment for the Arts, United States: collaborator

Study Sites (1)

MUSC Shawn Jenkin's Children's Hospital

Charleston, South Carolina, 29425, United States

Location

Related Publications (48)

• Scialla MA, Canter KS, Chen FF, Kolb EA, Sandler E, Wiener L, Kazak AE. Delivery of care consistent with the psychosocial standards in pediatric cancer: Current practices in the United States. Pediatr Blood Cancer. 2018 Mar;65(3):10.1002/pbc.26869. doi: 10.1002/pbc.26869. Epub 2017 Oct 28.

  PMID: 29080381 BACKGROUND

• Jibb LA, Nathan PC, Stevens BJ, Seto E, Cafazzo JA, Stephens N, Yohannes L, Stinson JN. Psychological and Physical Interventions for the Management of Cancer-Related Pain in Pediatric and Young Adult Patients: An Integrative Review. Oncol Nurs Forum. 2015 Nov;42(6):E339-57. doi: 10.1188/15.ONF.E339-E357.

  PMID: 26488841 BACKGROUND

• Ryan-Wenger NM. A taxonomy of children's coping strategies: a step toward theory development. Am J Orthopsychiatry. 1992 Apr;62(2):256-63. doi: 10.1037/h0079328.

  PMID: 1580343 BACKGROUND

• Clapp LA, Taylor EP, Di Folco S, Mackinnon VL. Effectiveness of art therapy with pediatric populations affected by medical health conditions: a systematic review. Arts Health. 2019 Oct;11(3):183-201. doi: 10.1080/17533015.2018.1443952. Epub 2018 Mar 5.

  PMID: 31038441 BACKGROUND

• Aguilar BA. The Efficacy of Art Therapy in Pediatric Oncology Patients: An Integrative Literature Review. J Pediatr Nurs. 2017 Sep-Oct;36:173-178. doi: 10.1016/j.pedn.2017.06.015. Epub 2017 Jun 30.

  PMID: 28888499 BACKGROUND

• Newland P, Bettencourt BA. Effectiveness of mindfulness-based art therapy for symptoms of anxiety, depression, and fatigue: A systematic review and meta-analysis. Complement Ther Clin Pract. 2020 Nov;41:101246. doi: 10.1016/j.ctcp.2020.101246. Epub 2020 Oct 13.

  PMID: 33075726 BACKGROUND

• Kuntze G, Nesbitt C, Whittaker JL, Nettel-Aguirre A, Toomey C, Esau S, Doyle-Baker PK, Shank J, Brooks J, Benseler S, Emery CA. Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Jan;99(1):178-193.e1. doi: 10.1016/j.apmr.2017.05.030. Epub 2017 Jul 18.

  PMID: 28729171 BACKGROUND

• Tang WX, Zhang LF, Ai YQ, Li ZS. Efficacy of Internet-delivered cognitive-behavioral therapy for the management of chronic pain in children and adolescents: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(36):e12061. doi: 10.1097/MD.0000000000012061.

  PMID: 30200086 BACKGROUND

• Gonzales A, Gates E, Bhunia N, Mehyar L, Hashem H, Stanek JR, Krebs B, Auletta JJ. Transplant Energize Me Patient Outcome (TEMPO): A Quality Improvement Project that Maintains Functional Mobility in Pediatric Patients Admitted for Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2019 Sep;25(9):1779-1785. doi: 10.1016/j.bbmt.2019.05.004. Epub 2019 May 11.

  PMID: 31085304 BACKGROUND

• Mohammed J, Smith SR, Burns L, Basak G, Aljurf M, Savani BN, Schoemans H, Peric Z, Chaudhri NA, Chigbo N, Alfred A, Bakhsh H, Salooja N, Chris Chim A, Hashmi SK. Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. Biol Blood Marrow Transplant. 2019 Jun;25(6):e191-e198. doi: 10.1016/j.bbmt.2019.01.018. Epub 2019 Jan 15.

  PMID: 30658224 BACKGROUND

• Taverna L, Tremolada M, Bonichini S, Tosetto B, Basso G, Messina C, Pillon M. Motor skill delays in pre-school children with leukemia one year after treatment: Hematopoietic stem cell transplantation therapy as an important risk factor. PLoS One. 2017 Oct 24;12(10):e0186787. doi: 10.1371/journal.pone.0186787. eCollection 2017.

  PMID: 29065156 BACKGROUND

• West SL, Gassas A, Schechter T, Egeler RM, Nathan PC, Wells GD. Exercise intolerance and the impact of physical activity in children treated with hematopoietic stem cell transplantation. Pediatr Exerc Sci. 2014 Aug;26(3):358-64. doi: 10.1123/pes.2013-0156. Epub 2014 Apr 10.

  PMID: 24721685 BACKGROUND

• Carenzio G, Gherardi P, Bardoni MT, Zecca M, Bonetti F, Locatelli F, Dalla Toffola E. Rehabilitation of chronic graft versus host disease in children. A clinical series. Eura Medicophys. 2007 Dec;43(4):445-50.

  PMID: 18084166 BACKGROUND

• Rosenhagen A, Bernhorster M, Vogt L, Weiss B, Senn A, Arndt S, Siegler K, Jung M, Bader P, Banzer W. Implementation of structured physical activity in the pediatric stem cell transplantation. Klin Padiatr. 2011 May;223(3):147-51. doi: 10.1055/s-0031-1271782. Epub 2011 Apr 1.

  PMID: 21462101 BACKGROUND

• San Juan AF, Chamorro-Vina C, Moral S, Fernandez del Valle M, Madero L, Ramirez M, Perez M, Lucia A. Benefits of intrahospital exercise training after pediatric bone marrow transplantation. Int J Sports Med. 2008 May;29(5):439-46. doi: 10.1055/s-2007-965571. Epub 2007 Oct 25.

  PMID: 17960520 BACKGROUND

• Chamorro-Vina C, Ruiz JR, Santana-Sosa E, Gonzalez Vicent M, Madero L, Perez M, Fleck SJ, Perez A, Ramirez M, Lucia A. Exercise during hematopoietic stem cell transplant hospitalization in children. Med Sci Sports Exerc. 2010 Jun;42(6):1045-53. doi: 10.1249/MSS.0b013e3181c4dac1.

  PMID: 19997035 BACKGROUND

• Chamorro-Vina C, Guilcher GM, Khan FM, Mazil K, Schulte F, Wurz A, Williamson T, Reimer RA, Culos-Reed SN. EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol. BMC Cancer. 2012 Sep 10;12:401. doi: 10.1186/1471-2407-12-401.

  PMID: 22963378 BACKGROUND

• Rossi F, Coppo M, Zucchetti G, Bazzano D, Ricci F, Vassallo E, Nesi F, Fagioli F. Rehabilitative intervention during and after pediatric hematopoietic stem cell transplantation: An analysis of the existing literature. Pediatr Blood Cancer. 2016 Nov;63(11):1895-904. doi: 10.1002/pbc.26114. Epub 2016 Jul 13.

  PMID: 27409063 BACKGROUND

• Jarden M, Hovgaard D, Boesen E, Quist M, Adamsen L. Pilot study of a multimodal intervention: mixed-type exercise and psychoeducation in patients undergoing allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 Oct;40(8):793-800. doi: 10.1038/sj.bmt.1705807. Epub 2007 Aug 20.

  PMID: 17704795 BACKGROUND

• Paniccia M, Paniccia D, Thomas S, Taha T, Reed N. Clinical and non-clinical depression and anxiety in young people: A scoping review on heart rate variability. Auton Neurosci. 2017 Dec;208:1-14. doi: 10.1016/j.autneu.2017.08.008. Epub 2017 Aug 26.

  PMID: 28870754 BACKGROUND

• Kirizawa JM, Garner DM, Arab C, Valenti VE. Is heart rate variability a valuable method to investigate cardiac autonomic dysfunction in subjects with leukemia? A systematic review to evaluate its importance in clinical practice. Support Care Cancer. 2020 Jan;28(1):35-42. doi: 10.1007/s00520-019-05047-x. Epub 2019 Aug 23.

  PMID: 31444641 BACKGROUND

• Kirizawa JM, Garner DM, Valenti VE. Impact of respiratory physical therapy on heart rate autonomic control in children with leukemia. Support Care Cancer. 2021 Mar;29(3):1585-1596. doi: 10.1007/s00520-020-05629-0. Epub 2020 Aug 1.

  PMID: 32740892 BACKGROUND

• Porges SW. The polyvagal perspective. Biol Psychol. 2007 Feb;74(2):116-43. doi: 10.1016/j.biopsycho.2006.06.009. Epub 2006 Oct 16.

  PMID: 17049418 BACKGROUND

• Porges SW. The polyvagal theory: new insights into adaptive reactions of the autonomic nervous system. Cleve Clin J Med. 2009 Apr;76 Suppl 2(Suppl 2):S86-90. doi: 10.3949/ccjm.76.s2.17.

  PMID: 19376991 BACKGROUND

• Rajendra Acharya U, Paul Joseph K, Kannathal N, Lim CM, Suri JS. Heart rate variability: a review. Med Biol Eng Comput. 2006 Dec;44(12):1031-51. doi: 10.1007/s11517-006-0119-0. Epub 2006 Nov 17.

  PMID: 17111118 BACKGROUND

• Biswas AK, Scott WA, Sommerauer JF, Luckett PM. Heart rate variability after acute traumatic brain injury in children. Crit Care Med. 2000 Dec;28(12):3907-12. doi: 10.1097/00003246-200012000-00030.

  PMID: 11153634 BACKGROUND

• McCain GC, Ludington-Hoe SM, Swinth JY, Hadeed AJ. Heart rate variability responses of a preterm infant to kangaroo care. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):689-94. doi: 10.1177/0884217505281857.

  PMID: 16282226 BACKGROUND

• Benevides TW, Lane SJ. A review of cardiac autonomic measures: considerations for examination of physiological response in children with autism spectrum disorder. J Autism Dev Disord. 2015 Feb;45(2):560-75. doi: 10.1007/s10803-013-1971-z.

  PMID: 24154761 BACKGROUND

• Schaaf RC, Benevides TW, Leiby BE, Sendecki JA. Autonomic dysregulation during sensory stimulation in children with autism spectrum disorder. J Autism Dev Disord. 2015 Feb;45(2):461-72. doi: 10.1007/s10803-013-1924-6.

  PMID: 23996198 BACKGROUND

• Haiblum-Itskovitch S, Czamanski-Cohen J, Galili G. Emotional Response and Changes in Heart Rate Variability Following Art-Making With Three Different Art Materials. Front Psychol. 2018 Jun 18;9:968. doi: 10.3389/fpsyg.2018.00968. eCollection 2018.

  PMID: 29967587 BACKGROUND

• Lin YF, Lairson DR, Chan W, Du XL, Leung KS, Kennedy-Nasser AA, Martinez CA, Heslop HE, Brenner MK, Krance RA. Children with acute leukemia: a comparison of outcomes from allogeneic blood stem cell and bone marrow transplantation. Pediatr Blood Cancer. 2011 Jan;56(1):143-51. doi: 10.1002/pbc.22677.

  PMID: 21108446 BACKGROUND

• Dumas HM, Fragala-Pinkham MA. Concurrent validity and reliability of the pediatric evaluation of disability inventory-computer adaptive test mobility domain. Pediatr Phys Ther. 2012 Summer;24(2):171-6; discussion 176. doi: 10.1097/PEP.0b013e31824c94ca.

  PMID: 22466386 BACKGROUND

• Haley SM, Coster WJ, Dumas HM, Fragala-Pinkham MA, Kramer J, Ni P, Tian F, Kao YC, Moed R, Ludlow LH. Accuracy and precision of the Pediatric Evaluation of Disability Inventory computer-adaptive tests (PEDI-CAT). Dev Med Child Neurol. 2011 Dec;53(12):1100-6. doi: 10.1111/j.1469-8749.2011.04107.x. Epub 2011 Nov 11.

  PMID: 22077695 BACKGROUND

• Shore BJ, Allar BG, Miller PE, Matheney TH, Snyder BD, Fragala-Pinkham M. Measuring the Reliability and Construct Validity of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) in Children With Cerebral Palsy. Arch Phys Med Rehabil. 2019 Jan;100(1):45-51. doi: 10.1016/j.apmr.2018.07.427. Epub 2018 Aug 18.

  PMID: 30130519 BACKGROUND

• Fragala-Pinkham MA, Dumas HM, Lombard KA, O'Brien JE. Responsiveness of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test in measuring functional outcomes for inpatient pediatric rehabilitation. J Pediatr Rehabil Med. 2016 Sep 2;9(3):215-22. doi: 10.3233/PRM-160382.

  PMID: 27612081 BACKGROUND

• Morinder G, Mattsson E, Sollander C, Marcus C, Larsson UE. Six-minute walk test in obese children and adolescents: reproducibility and validity. Physiother Res Int. 2009 Jun;14(2):91-104. doi: 10.1002/pri.428.

  PMID: 19003813 BACKGROUND

• Dunaway Young S, Montes J, Kramer SS, Marra J, Salazar R, Cruz R, Chiriboga CA, Garber CE, De Vivo DC. Six-minute walk test is reliable and valid in spinal muscular atrophy. Muscle Nerve. 2016 Nov;54(5):836-842. doi: 10.1002/mus.25120. Epub 2016 May 13.

  PMID: 27015431 BACKGROUND

• Mizrahi D, Fardell JE, Cohn RJ, Partin RE, Howell CR, Hudson MM, Robison LL, Ness KK, McBride J, Field P, Wakefield CE, Simar D. The 6-minute walk test is a good predictor of cardiorespiratory fitness in childhood cancer survivors when access to comprehensive testing is limited. Int J Cancer. 2020 Aug 1;147(3):847-855. doi: 10.1002/ijc.32819. Epub 2019 Dec 17.

  PMID: 31800093 BACKGROUND

• Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.

  PMID: 7962581 BACKGROUND

• McManis MH, Bradley MM, Berg WK, Cuthbert BN, Lang PJ. Emotional reactions in children: verbal, physiological, and behavioral responses to affective pictures. Psychophysiology. 2001 Mar;38(2):222-31.

  PMID: 11347868 BACKGROUND

• Sharp C, van Goozen S, Goodyer I. Children's subjective emotional reactivity to affective pictures: gender differences and their antisocial correlates in an unselected sample of 7-11-year-olds. J Child Psychol Psychiatry. 2006 Feb;47(2):143-50. doi: 10.1111/j.1469-7610.2005.01464.x.

  PMID: 16423145 BACKGROUND

• Murdoch M, Partin MR, Vang D, Kehle-Forbes SM. The Psychological Risk of Minimal Risk Activities: A Pre- and Posttest Study Using the Self-Assessment Manikin. J Empir Res Hum Res Ethics. 2019 Feb;14(1):15-22. doi: 10.1177/1556264618810302. Epub 2018 Nov 8.

  PMID: 30406711 BACKGROUND

• O'Neil ME, Fragala-Pinkham MA, Forman JL, Trost SG. Measuring reliability and validity of the ActiGraph GT3X accelerometer for children with cerebral palsy: a feasibility study. J Pediatr Rehabil Med. 2014;7(3):233-40. doi: 10.3233/PRM-140292.

  PMID: 25260506 BACKGROUND

• Hamari L, Kullberg T, Ruohonen J, Heinonen OJ, Diaz-Rodriguez N, Lilius J, Pakarinen A, Myllymaki A, Leppanen V, Salantera S. Physical activity among children: objective measurements using Fitbit One(R) and ActiGraph. BMC Res Notes. 2017 Apr 20;10(1):161. doi: 10.1186/s13104-017-2476-1.

  PMID: 28427441 BACKGROUND

• Quintana DS, Guastella AJ, Outhred T, Hickie IB, Kemp AH. Heart rate variability is associated with emotion recognition: direct evidence for a relationship between the autonomic nervous system and social cognition. Int J Psychophysiol. 2012 Nov;86(2):168-72. doi: 10.1016/j.ijpsycho.2012.08.012. Epub 2012 Aug 30.

  PMID: 22940643 BACKGROUND

• Ulrich S, Hildenbrand FF, Treder U, Fischler M, Keusch S, Speich R, Fasnacht M. Reference values for the 6-minute walk test in healthy children and adolescents in Switzerland. BMC Pulm Med. 2013 Aug 5;13:49. doi: 10.1186/1471-2466-13-49.

  PMID: 23915140 BACKGROUND

• Lammers AE, Hislop AA, Flynn Y, Haworth SG. The 6-minute walk test: normal values for children of 4-11 years of age. Arch Dis Child. 2008 Jun;93(6):464-8. doi: 10.1136/adc.2007.123653. Epub 2007 Aug 3.

  PMID: 17675356 BACKGROUND

• Li AM, Yin J, Au JT, So HK, Tsang T, Wong E, Fok TF, Ng PC. Standard reference for the six-minute-walk test in healthy children aged 7 to 16 years. Am J Respir Crit Care Med. 2007 Jul 15;176(2):174-80. doi: 10.1164/rccm.200607-883OC. Epub 2007 Apr 26.

  PMID: 17463419 BACKGROUND

MeSH Terms

Interventions

Reproductive Techniques, Assisted; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques; Rehabilitation

Limitations and Caveats

Nothing to report.

Results Point of Contact

• Title: Cynthia Dodds, PT, PhD
• Organization: Medical University of South Carolina

doddscb@musc.edu

8437925731

Study Officials

• Cindy Dodds, PhD

  MUSC College of Health Professions

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 1, 2022
• Study Start: October 12, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)