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).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

18 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)

Results posted on

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Physical Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 8437925731

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place