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.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary aim of this monocentric randomised controlled study is to evaluate the impact of using GAS to maintain the functional abilities of children and adolescents undergoing TCSE. The secondary aims include evaluating parents' and adolescents' perceived changes in the subject's functional abilities from the moment of stem cell transplantation unit (SCTU) admission to subsequent follow-ups. Another secondary aim is to evaluate the achievement of functional goals as defined by GAS in the experimental group (EG). Other aims include investigating the feasibility of the exercise program and the rehabilitation counselling indications in both groups, as well as the effectiveness of the two interventions and GAS use in the EG.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
A.O.U. Città della Salute e della Scienza - OIRM
RECRUITING
Torino
Contact Information
Primary
Francesco Saglio, PhD Medical Doctor
francesco.saglio@unito.it
+39 0113135449
Backup
Francesca Rossi
francesca.rossi@unito.it
+39 0113131643
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2027-12-23
Participants
Target number of participants: 176
Treatments
Other: Exercise programme (EP) and rehabilitation counselling indication (RCI)
Exercise Program EP is carried out five days a week (two days independently with parental support and three days under supervision). Each 30-minute session is supervised by one therapist for all patients. The EP programme includes three types of exercise: muscle-strengthening exercises for the upper and lower extremities, preceded by a 10-minute warm-up; 15 minutes of aerobic exercise; and 5 minutes of stretching.~Rehabilitation counselling indications RCI have to be followed daily. RCI consist of some practical advice on how to adopt an active lifestyle during recovery. Some examples are getting up to go to the bathroom or the window to talk to visitors, sitting on a chair for school lessons.
Experimental: Exercise programme (EP), rehabilitation counselling indication (RCI) and Goal Attaiment Scale (GAS)
Exercise Program EP is carried out five days a week (two days independently with parental support and three days under supervision). Each 30-minute session is supervised by one therapist for all patients. The EP programme includes three types of exercise: muscle-strengthening exercises for the upper and lower extremities, preceded by a 10-minute warm-up; 15 minutes of aerobic exercise; and 5 minutes of stretching.~Rehabilitation counselling indications RCI have to be followed daily. RCI consist of some practical advice on how to adopt an active lifestyle during recovery. Some examples are getting up to go to the bathroom or the window to talk to visitors, sitting on a chair for school lessons.~GAS During their hospitalisation, children and caregivers in the experimental group define a functional goal together each week with the help of the therapist. This is verified using Goal Attainment Scaling, which identifies specific and significant objectives for the patient and their family.
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

This content was sourced from clinicaltrials.gov

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