Virtual Buddy Movement Therapy for Psychomotor and Social Development in Pediatric Oncology Patients in Remission

May 1, 2026 updated by: Adriana Kaplanova, Comenius University

The Impact of a 12-week Virtual Buddy-movement Therapy on the Psychomotor and Social Development of Pediatric Oncology Patients in Remission

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 83340
        • Recruiting
        • National Institute of Children´s Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 5-12 years
  • Diagnosis: acute lymphoblastic leukemia in complete remission
  • First-line treatment of acute lymphoblastic leukemia according to the treatment protocol
  • BUDDY - a healthy friend aged 5-12 years

Exclusion Criteria:

  • Participation in the movement program less than 80%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Buddy-Movement Therapy
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

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.
No Intervention: No-intervention Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor Proficiency as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Time Frame: baseline and 12 weeks

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.
baseline and 12 weeks
Change in Health-Related Quality of Life (PedsQL)
Time Frame: Baseline and 12 weeks
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).
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: baseline and 12 weeks
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.
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Comenius University

Collaborators

National Institute of Children's Diseases, Slovakia
Scientific Grant Agency (VEGA) of Slovakia

Investigators

  • Principal Investigator: Adriana Kaplánová, PhD., Comenius University Bratislava, Slovakia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 4, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/11/4/2025
  • 1/0558/25 (Other Identifier: Scientific Grant Agency (VEGA) of Slovakia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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