Personalized goal-based rehabilitation during pediatric stem cell transplant
Using Goal Attainment Scale (GAS) to Increase Active Involvement of Patients and Their Family in the Identification of Functional Objectives During Hospitalization for Hematopoietic Stem Cell Transplantation (HSCT): a Randomized Controlled Trial.
This will try a personalized Goal Attainment Scale to help children and teens (6 months–17 years) keep or improve physical abilities during hematopoietic stem cell transplantation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 6 Months to 17 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna Academic / other |
| Locations | 1 site (Torino, TO) |
| Trial ID | NCT07372690 on ClinicalTrials.gov |
What this trial studies
In this single-center randomized controlled trial, children and adolescents undergoing hematopoietic stem cell transplantation are assigned to a Goal Attainment Scale (GAS)–guided rehabilitation program or a control intervention. The experimental group receives individualized goal-setting with GAS plus an exercise and rehabilitation program, while the control group receives standard rehabilitation counselling and exercise as per usual care. Outcomes include GAS-defined goal achievement, parent and adolescent perceptions of functional change from admission through follow-up, feasibility measures, and objective motor-performance metrics. The study is conducted at a pediatric transplant center in Torino, Italy and enrolls patients aged 6 months to 17 years 11 months with oncologic or hematologic indications for HSCT.
Who should consider this trial
Good fit: Children and adolescents aged 6 months to 17 years 11 months undergoing hematopoietic stem cell transplantation for oncologic or hematologic conditions who are not already receiving specific rehabilitation and whose guardians provide consent.
Not a fit: Patients who cannot comply with study visits or procedures, those already receiving targeted rehabilitation at enrollment, or those with medical complications that prevent participation in exercise may not benefit.
Why it matters
Potential benefit: If successful, GAS-guided rehabilitation could help preserve or improve motor function and quality of life for children undergoing HSCT.
How similar studies have performed: Previous research and meta-analyses show exercise and rehabilitation are safe and can prevent decline in physical performance and quality of life in pediatric HSCT, but use of GAS for goal-directed rehab in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 6 months - 17 years and 11 months * diagnosis of oncological or hematological disease undergoing HSCT * No specific rehabilitation treatment ongoing at the moment of recruitment * Written informed consent from patient or parents/legal representative, and age-appropriate assent. Exclusion Criteria: * Patients that are not able and willing to comply with study visits and procedures.
Where this trial is running
Torino, TO
- A.O.U. Città della Salute e della Scienza - OIRM — Torino, To, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Saglio, PhD Medical Doctor — A.O.U. Città della Salute e della Scienza - OIRM
- Study coordinator: Francesco Saglio, PhD Medical Doctor
- Email: francesco.saglio@unito.it
- Phone: +39 0113135449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.