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| ID | Type | Description | Link |
|---|---|---|---|
| 1891731-38-22 | Other Grant/Funding Number | National Endowment of the Arts |
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| Name | Class |
|---|---|
| National Endowment for the Arts, United States | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Physical Therapy | Active Comparator | PT Monday through Friday for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Art and Physical Therapy | Behavioral | 45 minutes of Art Therapy followed by 30 minutes of Physical Therapy, Monday through Friday for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy Dodds, PhD | MUSC College of Health Professions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Shawn Jenkin's Children's Hospital | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29080381 | Background | 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. | |
| 26488841 | Background |
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Participants were excluded if they were undergoing a hematopoietic cell transplant for non-malignant diagnoses.
Recruitment began in September of 2022. Participants were recruited from the physicians, art therapists, occupational therapists, and physical therapist, who served children undergoing hematopoietic cell transplants.
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| ID | Title | Description |
|---|---|---|
| FG000 | AT and PT | Art and physiscal therapies provided |
| FG001 | PT Only | Physical therapy only provided |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Art and Physical Therapy: 45 minutes of Art Therapy followed by 30 minutes of Physical Therapy, Monday through Friday for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 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) |
|
2 years 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Art and Physical Therapy: 45 minutes of Art Therapy followed by 30 minutes of Physical Therapy, Monday through Friday for 2 weeks |
Not provided
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Nothing to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Dodds, PT, PhD | Medical University of South Carolina | 8437925731 | doddscb@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2024 | Nov 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2024 | Jan 9, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D012046 | Rehabilitation |
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| Physical Therapy | Behavioral | 30 minutes of Physical Therapy, Monday through Friday for 2 weeks |
|
| 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) |
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| BG001 | Physical Therapy | PT Monday through Friday for 2 weeks. Physical Therapy: 30 minutes of Physical Therapy, Monday through Friday for 2 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Physical Therapy | PT Monday through Friday for 2 weeks. Physical Therapy: 30 minutes of Physical Therapy, Monday through Friday for 2 weeks |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Meter | Pre- and post- testing before and after the 10 day intervention. Baseline day before intervention (Day 0), Day after intervention completion (Day 11) |
|
|
|
| Secondary | 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. | Not Posted | Dec 2026 | 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) | Participants |
| Secondary | Respiratory Sinus Arrhythmia | Not Posted | Dec 2026 | 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) | Participants |
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Physical Therapy | PT Monday through Friday for 2 weeks. Physical Therapy: 30 minutes of Physical Therapy, Monday through Friday for 2 weeks | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided