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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
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

Study 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.Check my eligibility
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.See study design
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.

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,944 Total Patients Enrolled
National Endowment for the Arts, United StatesFED
10 Previous Clinical Trials
1,951 Total Patients Enrolled
Cindy Dodds, PhDPrincipal InvestigatorMUSC College of Health Professions

Media Library

Art and Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05441670 — N/A
Bone Marrow Transplant Research Study Groups: Art and Physical Therapy, Physical Therapy
Bone Marrow Transplant Clinical Trial 2023: Art and Physical Therapy Highlights & Side Effects. Trial Name: NCT05441670 — N/A
Art and Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441670 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are enrolled in this research project?

"Affirmative. According to the data on clinicaltrials.gov, this medical trial has been looking for participants since October 12th 2022 and was recently updated on November 7th 2022. The research is aiming to recruit 20 patients from a single site."

Answered by AI

Are there any openings in this research trial for study participants?

"Affirmative. Clinicaltrials.gov's records show that, since its initial posting in October 12th 2022, this clinical trial has been actively searching for 20 participants from one centre."

Answered by AI

Does this research study encompass elderly subject participation?

"This trial is open for enrolment to those aged between 5 and 18 years old."

Answered by AI
~3 spots leftby Oct 2024