Trial Outcomes & Findings for Art and Physical Therapy in Pediatric HCT (NCT NCT05441670)
NCT ID: NCT05441670
Last Updated: 2026-01-15
Results Overview
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).
ACTIVE_NOT_RECRUITING
NA
18 participants
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)
2026-01-15
Participant Flow
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.
Participants were excluded if they were undergoing a hematopoietic cell transplant for non-malignant diagnoses.
Participant milestones
| Measure |
AT and PT
Art and physiscal therapies provided
|
PT Only
Physical therapy only provided
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
AT and PT
Art and physiscal therapies provided
|
PT Only
Physical therapy only provided
|
|---|---|---|
|
Overall Study
Two participants completed intervention but not post-test due to ICU admit and family challenges.
|
0
|
2
|
Baseline Characteristics
Art and Physical Therapy in Pediatric HCT
Baseline characteristics by cohort
| Measure |
Art and Physical Therapy
n=9 Participants
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
|
Physical Therapy
n=9 Participants
PT Monday through Friday for 2 weeks.
Physical Therapy: 30 minutes of Physical Therapy, Monday through Friday for 2 weeks
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
131.6 Months
STANDARD_DEVIATION 56.2 • n=9 Participants
|
137.7 Months
STANDARD_DEVIATION 52.3 • n=6 Participants
|
134.6 Months
STANDARD_DEVIATION 53.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
9 participants
n=6 Participants
|
18 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Art and Physical Therapy
n=9 Participants
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
|
Physical Therapy
n=9 Participants
PT Monday through Friday for 2 weeks.
Physical Therapy: 30 minutes of Physical Therapy, Monday through Friday for 2 weeks
|
|---|---|---|
|
Changes in Scaled Scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT)
|
1.56 units on a scale
Standard Deviation 2.35
|
2.67 units on a scale
Standard Deviation 1.80
|
PRIMARY outcome
Timeframe: 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 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.
Outcome measures
| Measure |
Art and Physical Therapy
n=9 Participants
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
|
Physical Therapy
n=9 Participants
PT Monday through Friday for 2 weeks.
Physical Therapy: 30 minutes of Physical Therapy, Monday through Friday for 2 weeks
|
|---|---|---|
|
Changes in Walking Distance on the 6-Minute Walk Test (6WMT)
|
304.02 Meter
Standard Deviation 122.02
|
280.87 Meter
Standard Deviation 120.16
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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)Outcome measures
Outcome data not reported
Adverse Events
Art and Physical Therapy
Physical Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cynthia Dodds, PT, PhD
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place