- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441670
Art and Physical Therapy in Pediatric HCT
October 31, 2023 updated by: Cindy Dodds, Medical University of South Carolina
The Effect of a Collaborative Art Therapy and Physical Therapy Intervention on Children Undergoing a Hematopoietic Cell Transplant (HCT): a Randomized Clinical Trial
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cindy Dodds, PhD
- Phone Number: 843-792-5731
- Email: doddscb@musc.edu
Study Contact Backup
- Name: Stephanie Wilson, OTR/L
- Email: wilsonsg@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- MUSC Shawn Jenkin's Children's Hospital
-
Contact:
- Caitlin Keller, DPT
- Email: kellerca@musc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Art and Physical Therapy
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.
|
45 minutes of Art Therapy followed by 30 minutes of Physical Therapy, Monday through Friday for 2 weeks
|
Active Comparator: Physical Therapy
PT Monday through Friday for 2 weeks.
|
30 minutes of Physical Therapy, Monday through Friday for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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)
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.
|
Pre- and post- testing before and after the 10 day intervention. Baseline day before intervention (Day 0), Day after intervention completion (Day 11)
|
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.
|
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)
|
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.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Cindy Dodds, PhD, MUSC College of Health Professions
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2022
Primary Completion (Estimated)
October 12, 2024
Study Completion (Estimated)
October 12, 2024
Study Registration Dates
First Submitted
June 23, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (Actual)
July 1, 2022
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 00119657
- 1891731-38-22 (Other Grant/Funding Number: National Endowment of the Arts)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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