Hematopoietic Stem Cell TransplantationNCT05441670
Art and Physical Therapy in Pediatric HCT
A study testing Art and Physical Therapy and Physical Therapy in people with Hematopoietic Stem Cell Transplantation and Art Therapy, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Art Therapy, Physical Therapy
- What is being tested?
- Art and Physical Therapy and Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- between ages 5 to 18
- Clinical Diagnosis of hematological disease
- Undergoing Hematopoietic Cell Transplantation (HCT)
- Within the inpatient hospital treatment phase of HCT
Who cannot join
- Less than age 5
- Older than age 18
- Central nervous system impairments (e.g., cerebral palsy)
- Genetic diseases (e.g., Down syndrome)
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC Shawn Jenkin's Children's Hospital
Charleston, South Carolina, 29425
About this study
Official title: The Effect of a Collaborative Art Therapy and Physical Therapy Intervention on Children Undergoing a Hematopoietic Cell Transplant (HCT): a Randomized Clinical Trial
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.
Read the detailed description
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.
- Being tested
- Art and Physical Therapy, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art and Physical TherapyBehavioural
45 minutes of Art Therapy followed by 30 minutes of Physical Therapy, Monday through Friday for 2 weeks
Physical TherapyBehavioural
30 minutes of Physical Therapy, Monday through Friday for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Art and Physical Therapy |
| Physical Therapy | Active comparator | PT Monday through Friday for 2 weeks. Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Pre- and post- testing before and after the 10 day intervention. Baseline day before intervention (Day 0), Day after intervention completion (Day 11)
Secondary outcomes (2)
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.
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start12 Oct 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Responsible party
- Sponsor
- Investigators
- Cindy Dodds, PhD, Principal investigator, MUSC College of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441670
- Sponsor's protocol ID
- 00119657
- Other IDs
- 1891731-38-22
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2022
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29080381Jibb LA, Nathan PC, Stevens BJ, Seto E, Cafazzo JA, Stephens N, Yohannes L, Stinson JN. Psychological and Physical Interventions for the Management of Cancer-Related Pain in Pediatric and Young Adult Patients: An Integrative Review. Oncol Nurs Forum. 2015 Nov;42(6):E339-57. doi: 10.1188/15.ONF.E339-E357.
PubMed 26488841Ryan-Wenger NM. A taxonomy of children's coping strategies: a step toward theory development. Am J Orthopsychiatry. 1992 Apr;62(2):256-63. doi: 10.1037/h0079328.
PubMed 1580343Clapp LA, Taylor EP, Di Folco S, Mackinnon VL. Effectiveness of art therapy with pediatric populations affected by medical health conditions: a systematic review. Arts Health. 2019 Oct;11(3):183-201. doi: 10.1080/17533015.2018.1443952. Epub 2018 Mar 5.
PubMed 31038441Aguilar BA. The Efficacy of Art Therapy in Pediatric Oncology Patients: An Integrative Literature Review. J Pediatr Nurs. 2017 Sep-Oct;36:173-178. doi: 10.1016/j.pedn.2017.06.015. Epub 2017 Jun 30.
PubMed 28888499Newland P, Bettencourt BA. Effectiveness of mindfulness-based art therapy for symptoms of anxiety, depression, and fatigue: A systematic review and meta-analysis. Complement Ther Clin Pract. 2020 Nov;41:101246. doi: 10.1016/j.ctcp.2020.101246. Epub 2020 Oct 13.
PubMed 33075726Kuntze G, Nesbitt C, Whittaker JL, Nettel-Aguirre A, Toomey C, Esau S, Doyle-Baker PK, Shank J, Brooks J, Benseler S, Emery CA. Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Jan;99(1):178-193.e1. doi: 10.1016/j.apmr.2017.05.030. Epub 2017 Jul 18.
PubMed 28729171Tang WX, Zhang LF, Ai YQ, Li ZS. Efficacy of Internet-delivered cognitive-behavioral therapy for the management of chronic pain in children and adolescents: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(36):e12061. doi: 10.1097/MD.0000000000012061.
PubMed 30200086Gonzales A, Gates E, Bhunia N, Mehyar L, Hashem H, Stanek JR, Krebs B, Auletta JJ. Transplant Energize Me Patient Outcome (TEMPO): A Quality Improvement Project that Maintains Functional Mobility in Pediatric Patients Admitted for Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2019 Sep;25(9):1779-1785. doi: 10.1016/j.bbmt.2019.05.004. Epub 2019 May 11.
PubMed 31085304Mohammed J, Smith SR, Burns L, Basak G, Aljurf M, Savani BN, Schoemans H, Peric Z, Chaudhri NA, Chigbo N, Alfred A, Bakhsh H, Salooja N, Chris Chim A, Hashmi SK. Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. Biol Blood Marrow Transplant. 2019 Jun;25(6):e191-e198. doi: 10.1016/j.bbmt.2019.01.018. Epub 2019 Jan 15.
PubMed 30658224Taverna L, Tremolada M, Bonichini S, Tosetto B, Basso G, Messina C, Pillon M. Motor skill delays in pre-school children with leukemia one year after treatment: Hematopoietic stem cell transplantation therapy as an important risk factor. PLoS One. 2017 Oct 24;12(10):e0186787. doi: 10.1371/journal.pone.0186787. eCollection 2017.
PubMed 29065156West SL, Gassas A, Schechter T, Egeler RM, Nathan PC, Wells GD. Exercise intolerance and the impact of physical activity in children treated with hematopoietic stem cell transplantation. Pediatr Exerc Sci. 2014 Aug;26(3):358-64. doi: 10.1123/pes.2013-0156. Epub 2014 Apr 10.
PubMed 24721685Carenzio G, Gherardi P, Bardoni MT, Zecca M, Bonetti F, Locatelli F, Dalla Toffola E. Rehabilitation of chronic graft versus host disease in children. A clinical series. Eura Medicophys. 2007 Dec;43(4):445-50.
PubMed 18084166Rosenhagen A, Bernhorster M, Vogt L, Weiss B, Senn A, Arndt S, Siegler K, Jung M, Bader P, Banzer W. Implementation of structured physical activity in the pediatric stem cell transplantation. Klin Padiatr. 2011 May;223(3):147-51. doi: 10.1055/s-0031-1271782. Epub 2011 Apr 1.
PubMed 21462101San Juan AF, Chamorro-Vina C, Moral S, Fernandez del Valle M, Madero L, Ramirez M, Perez M, Lucia A. Benefits of intrahospital exercise training after pediatric bone marrow transplantation. Int J Sports Med. 2008 May;29(5):439-46. doi: 10.1055/s-2007-965571. Epub 2007 Oct 25.
PubMed 17960520
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Collaborative Art Therapy and Physical Therapy Intervention on Children Undergoing a Hematopoietic Cell Transplant (HCT): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05441670
- Acronym / sponsor ID
- 00119657
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Posted 15 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art and Physical Therapy | Experimental | Behavioral: Art and Physical Therapy45-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 | Behavioral: Physical TherapyPT Monday through Friday for 2 weeks. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- between ages 5 to 18
- Clinical Diagnosis of hematological disease
- Undergoing Hematopoietic Cell Transplantation (HCT)
- Within the inpatient hospital treatment phase of HCT
Key exclusion criteria (5 listed)
- Less than age 5
- Older than age 18
- Central nervous system impairments (e.g., cerebral palsy)
- Genetic diseases (e.g., Down syndrome)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art and Physical Therapy45 minutes of Art Therapy followed by 30 minutes of Physical Therapy, Monday through Friday for 2 weeks | Behavioural | Art and Physical Therapy |
| Physical Therapy30 minutes of Physical Therapy, Monday through Friday for 2 weeks | Behavioural | Physical Therapy |
Primary outcome
Changes in Scaled Scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT)
Time frame: 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).
Changes in Walking Distance on the 6-Minute Walk Test (6WMT)
Time frame: 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.
2 secondary outcomes
Changes in the Self-Assessment Manikin (SAM)
Time frame: 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
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29080381Scialla 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.
- Background: PubMed 26488841Jibb LA, Nathan PC, Stevens BJ, Seto E, Cafazzo JA, Stephens N, Yohannes L, Stinson JN. Psychological and Physical Interventions for the Management of Cancer-Related Pain in Pediatric and Young Adult Patients: An Integrative Review. Oncol Nurs Forum. 2015 Nov;42(6):E339-57. doi: 10.1188/15.ONF.E339-E357.
- Background: PubMed 1580343Ryan-Wenger NM. A taxonomy of children's coping strategies: a step toward theory development. Am J Orthopsychiatry. 1992 Apr;62(2):256-63. doi: 10.1037/h0079328.
- Background: PubMed 31038441Clapp LA, Taylor EP, Di Folco S, Mackinnon VL. Effectiveness of art therapy with pediatric populations affected by medical health conditions: a systematic review. Arts Health. 2019 Oct;11(3):183-201. doi: 10.1080/17533015.2018.1443952. Epub 2018 Mar 5.
- Background: PubMed 28888499Aguilar BA. The Efficacy of Art Therapy in Pediatric Oncology Patients: An Integrative Literature Review. J Pediatr Nurs. 2017 Sep-Oct;36:173-178. doi: 10.1016/j.pedn.2017.06.015. Epub 2017 Jun 30.
- Background: PubMed 33075726Newland P, Bettencourt BA. Effectiveness of mindfulness-based art therapy for symptoms of anxiety, depression, and fatigue: A systematic review and meta-analysis. Complement Ther Clin Pract. 2020 Nov;41:101246. doi: 10.1016/j.ctcp.2020.101246. Epub 2020 Oct 13.
- Background: PubMed 28729171Kuntze G, Nesbitt C, Whittaker JL, Nettel-Aguirre A, Toomey C, Esau S, Doyle-Baker PK, Shank J, Brooks J, Benseler S, Emery CA. Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Jan;99(1):178-193.e1. doi: 10.1016/j.apmr.2017.05.030. Epub 2017 Jul 18.
- Background: PubMed 30200086Tang WX, Zhang LF, Ai YQ, Li ZS. Efficacy of Internet-delivered cognitive-behavioral therapy for the management of chronic pain in children and adolescents: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(36):e12061. doi: 10.1097/MD.0000000000012061.
- Background: PubMed 31085304Gonzales A, Gates E, Bhunia N, Mehyar L, Hashem H, Stanek JR, Krebs B, Auletta JJ. Transplant Energize Me Patient Outcome (TEMPO): A Quality Improvement Project that Maintains Functional Mobility in Pediatric Patients Admitted for Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2019 Sep;25(9):1779-1785. doi: 10.1016/j.bbmt.2019.05.004. Epub 2019 May 11.
- Background: PubMed 30658224Mohammed J, Smith SR, Burns L, Basak G, Aljurf M, Savani BN, Schoemans H, Peric Z, Chaudhri NA, Chigbo N, Alfred A, Bakhsh H, Salooja N, Chris Chim A, Hashmi SK. Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. Biol Blood Marrow Transplant. 2019 Jun;25(6):e191-e198. doi: 10.1016/j.bbmt.2019.01.018. Epub 2019 Jan 15.
- Background: PubMed 29065156Taverna L, Tremolada M, Bonichini S, Tosetto B, Basso G, Messina C, Pillon M. Motor skill delays in pre-school children with leukemia one year after treatment: Hematopoietic stem cell transplantation therapy as an important risk factor. PLoS One. 2017 Oct 24;12(10):e0186787. doi: 10.1371/journal.pone.0186787. eCollection 2017.
- Background: PubMed 24721685West SL, Gassas A, Schechter T, Egeler RM, Nathan PC, Wells GD. Exercise intolerance and the impact of physical activity in children treated with hematopoietic stem cell transplantation. Pediatr Exerc Sci. 2014 Aug;26(3):358-64. doi: 10.1123/pes.2013-0156. Epub 2014 Apr 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Dodds, PhD principal investigator
MUSC College of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art and Physical Therapy and Physical Therapy in people with Hematopoietic Stem Cell Transplantation and Art Therapy, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Scaled Scores of the Pediatric Evaluation of Disability Inventory - Computerized Adapted Test (PEDI-CAT) (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441670, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.