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Art and Physical Therapy for Bone Marrow Transplant Patients

N/A

Recruiting

Led By Cindy Dodds, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing Hematopoietic Cell Transplantation (HCT)

Within the inpatient hospital treatment phase of HCT

Must not have

Older than age 18

Genetic diseases (e.g., Down syndrome)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Summary

This trialwill compare the effects of art therapy and physical therapy to just physical therapy on children with HCT. Outcomes will measure happiness, self-care, and mobility.

Who is the study for?

This trial is for children aged 5-18 undergoing bone marrow transplant (HCT) for blood diseases, who are in the hospital treatment phase. It's not suitable for those with brain impairments like cerebral palsy, cognitive issues, or genetic conditions such as Down syndrome.

What is being tested?

The study compares art therapy combined with physical therapy to just physical therapy over two weeks post-transplant. The goal is to see if adding art improves heart rate variability, walking distance, happiness and excitability compared to physical therapy alone.

What are the potential side effects?

Since this trial involves non-invasive therapies like art and exercise, side effects may be minimal but could include typical responses to physical activity such as fatigue or muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am undergoing a bone marrow transplant.

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I am currently hospitalized for a stem cell transplant.

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I am between 5 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am older than 18.

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I have a genetic condition like Down syndrome.

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I am under 5 years old.

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I have a condition like cerebral palsy affecting my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in values of Respiratory Sinus Arrhythmia (RSA) derived from Heart Rate Variability as captured by ECG

Changes in scaled scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT)

Changes in the Self-Assessment Manikin (SAM)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Art and Physical TherapyExperimental Treatment1 Intervention

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.

Group II: Physical TherapyActive Control1 Intervention

PT Monday through Friday for 2 weeks.

0 / 7Eligibility criteria met