Art and Physical Therapy for Hematopoietic stem cells

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hematopoietic stem cells+2 More
Art and Physical Therapy - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Physical Therapy
  • Hematopoietic stem cells
  • Art Therapy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hematopoietic stem cells

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 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)

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)
Changes in the Self-Assessment Manikin (SAM)
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)
Change in values of Respiratory Sinus Arrhythmia (RSA) derived from Heart Rate Variability as captured by ECG
Day 11
Changes in walking distance on the 6-Minute Walk Test (6WMT)
Day 11
Changes in scaled scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT)

Trial Safety

Safety Progress

1 of 3

Other trials for Hematopoietic stem cells

Trial Design

2 Treatment Groups

Physical Therapy
1 of 2
Art and Physical Therapy
1 of 2
Active Control
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Art and Physical Therapy · No Placebo Group · N/A

Art and Physical Therapy
Behavioral
Experimental Group · 1 Intervention: Art and Physical Therapy · Intervention Types: Behavioral
Physical Therapy
Behavioral
ActiveComparator Group · 1 Intervention: Physical Therapy · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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)

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
833 Previous Clinical Trials
5,373,204 Total Patients Enrolled
National Endowment for the Arts, United StatesFED
10 Previous Clinical Trials
1,951 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between ages 5 and 18.
You are undergoing a hematopoietic cell transplantation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.