An interventional study of Virtual BUDDY-Movement Therapy in Precursor Cell Lymphoblastic Leukemia-Lymphoma, sponsored by Comenius University. Recruiting at 1 site in Slovakia. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Comenius University · Not applicable, Interventional, and Supportive care
Acute lymphoblastic leukemia is the most common type of cancer in children diagnosed between the ages of two and five. After cancer treatment, children suffer from fatigue and exhaustion, and thus a decrease in daily physical activity. In addition, lack of physical activity and sports causes a decrease in strength and mobility and affects coordination of movements, proprioceptive perception and balance, which can lead to the occurrence of many injuries. In addition, physical inactivity in children who have survived cancer increases the risk of cardiovascular diseases or causes overweight and obesity. In addition, the separation of children with cancer from their peers harms social, emotional, physical and school indicators of quality of life. The aim of the project is to determine the impact of 12 weeks of buddy-movement therapy on the psychomotor and social development of pediatric cancer patients in remission. The investigators expect a significant improvement in the motor skills of pediatric oncology patients in remission, specifically in fine and gross motor skills, in coordination of both hands, in body coordination, in strength and dexterity. The investigators also assume that after the introduction of 12-week buddy-movement therapy, there will be a significant improvement in the quality of life of pediatric oncology patients in remission, specifically in emotional functioning, in social functioning, in physical functioning and in school functioning. Furthermore, it is anticipated that after the introduction of 12-week buddy-movement therapy, the study will notice significant differences in motor skills between the experimental and control groups. It is also assumed that after the introduction of 12-week buddy-movement therapy, significant differences in quality of life between the experimental and control groups will be observed. The research will involve pediatric oncology patients in remission aged 5 to 12 years with acute lymphoblastic leukemia - ALL, who are treated at the Department of Pediatric Hematology and Oncology of the National Institute of Children's Diseases (NÚDCH). The research participants will undergo an entry and exit examination, including body mass index (BMI; kg/m\^2) calculated from weight (kg), height (m), waist circumference (cm), hip circumference (cm), psychomotor examination using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, and quality of life measured by the Pediatric Quality of Life Inventory. They will be divided into a control and experimental group, with the experimental group undergoing a 12-week Buddy-movement therapy focused on the development of psychomotor skills and socialization of participants using Buddy peer support.
Acute lymphoblastic leukemia (hereinafter referred to as ALL) is the most common cancer in children diagnosed between the second and fifth year of life. It is a highly aggressive type of leukemia that arises from the malignant proliferation of cells in a child's gland or bone marrow. Currently, thanks to multimodality treatment, including surgical treatment, radiotherapy, and chemotherapy, more than 75% of pediatric oncology patients can be cured. The treatment of ALL is very difficult and possible only in hemato-oncology centers, which causes the separation of children with cancer from the group of peers and has a negative impact, above all, on social, emotional, physical, and school quality of life indicators. The demanding course of treatment makes it impossible for children to participate in joint sports and play activities, which play an important role in the psychosocial development of children and adolescents. During chemotherapy in children and ALL, there is fatigue and a significant decrease in activity level, manifested by motor delays and limitations in activity, including problems with flexibility, posture, walking balance, or functional mobility. Other undesirable side effects include a decrease in physical fitness, a low level of cardiorespiratory fitness, a deficit in muscle strength, or a decrease in bone mineral density, etc. In addition to general weakness and pain, impairment of physical performance is also attributed to muscle atrophy, which may be the result of malnutrition, inflammation, lack of exercise, or side effects of glucocorticoid treatment. In addition, physical inactivity in child cancer survivors increases the risk of cardiovascular disease or is the cause of increasing overweight and obesity. Given the key role that physical activity plays in this developmental period, the problem of physical inactivity is becoming increasingly worrisome. Studies show that more than 50% of cancer patients in remission do not meet the CDC recommendations for 60 minutes of moderate to vigorous physical activity. Children who have survived cancer are generally less physically active than healthy children, which is usually associated precisely with psychological indicators of quality of life, with a decrease in self-esteem, fear of ridicule, as well as with feelings of inability and incompetence to integrate into existing social relationships between peers. Although considerable progress has been achieved in the field of pediatric oncology and medical treatment of ALL, effective therapeutic procedures reflecting the psychomotor and social delays of cured pediatric oncology patients are currently still absent.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Comenius University is the lead sponsor of 42 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group of participants will undergo a 12-week BUDDY movement therapy focused on the development of psychomotor skills and socialization of pediatric oncology patients.
Behavioral: Virtual BUDDY-Movement Therapy
Participants in the control group will not participate in the virtual buddy-movement therapy. Over the course of 12 weeks, they will maintain their usual daily routine and standard follow-up care without any added targeted physical activity. Psychomotor performance and quality of life assesments will be conducted at the same time intervals as the experimental group (baseline and at 12 weeks) to provide comparative data.
Buddy - Movement Therapy (BMT) uses elements of integrative movement therapy, psychomotor therapy with activation programs and concentration psychomotor therapy depending on the training unit schedule (Hatlová 2003). The duration of buddy-movement therapy is set at 12 weeks with a frequency of 2x per week for 60 minutes. The main part of BMT will be thematic and will consist of 4 modules, adapted to the age and specifics of children: a) mainly focused on the development of fine and gross motor skills; b) development of coordination of both hands; c) development of body coordination, d) development of strength and agility. Elements of activation psychomotor therapy will be implemented in it, including gymnastic exercises, dance and expressive sequences aimed at initiating cognitive and emotional processes with an emphasis on the emotional experience of the exercise in children.
Change in Motor Proficiency as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
The BOT-2 is a standardized instrument used to measure a wide range of motor skills. The BOT-2 complete form assesses 8 subtests of motor proficiency: Fine Motor Precision, Fine Motor Integration, Manual Dexterity, Bilateral Coordination, Balance, Running Speed and Agility, Upper - Limb Coordination, and Strength. The total point score is the sum of all item scores. The total raw point score ranges from 0 to 197. A higher score indicates better motor proficiency and physical performance. Standardized scores (Scale scores and Composite scores) will also be calculated for age-normative comparison.
Time frame: baseline and 12 weeks
Change in Health-Related Quality of Life (PedsQL)
The PedsQL consist of 23 items assessing four multidimensional subscales: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). A 5-point response scale is utilized 0 = never a problem; 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0 - 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). The total score is sum of all items divided by number of items answered. Total scores range from 0 to 100, where higher scores indicate better health-related quality of life (less negative impact).
Time frame: Baseline and 12 weeks
Change in Body Mass Index (BMI)
Body mass index (BMI; kg/m\^2) will be calculated from weight (kg), height (m), waist circumference (cm), hip circumference (cm) We will also monitor waist (cm) and hip circumference (cm) to assess body composition changes.
Time frame: baseline and 12 weeks
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.
Of 207 non-industry interventional studies with no phase under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 66. This study's planned 8 months is below that.
Counting every sponsor, half of 214 studies reached it within 32 months; a quarter within 12 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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