Precursor Cell Lymphoblastic Leukemia-LymphomaNCT07522905
Virtual Buddy Movement Therapy for Psychomotor and Social Development in Pediatric Oncology Patients in Remission
A study testing Virtual BUDDY-Movement Therapy in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Comenius University at 1 site in Slovakia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- Virtual BUDDY-Movement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSlovakia
- Study dates
- 7 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Participation in the movement program less than 80%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
National Institute of Children´s Diseases
Bratislava, 83340
Alexandra Kolenová, prof. MUDR. PhD., +421259371512, sekretariat@nudch.eu
About this study
Official title: 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.
Read the 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.
- Being tested
- Virtual BUDDY-Movement Therapy
- Keywords
- Pediatric Cancer Survivors, Acute Lymphoblastic Leukemia, Movement Therapy, Psychomotor development, Quality of life, BUDDY
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual BUDDY-Movement TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Buddy-Movement Therapy | Experimental | 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. Receives: Behavioral: Virtual BUDDY-Movement Therapy |
| No-intervention Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline and 12 weeks
Secondary outcomes (1)
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.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start7 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Precursor Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Children's Diseases, Slovakia, Scientific Grant Agency (VEGA) of Slovakia
- Responsible party
- Principal investigator, Adriana Kaplanova, Comenius University
- Investigators
- Adriana Kaplánová, PhD., Principal investigator, Comenius University Bratislava, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522905
- Sponsor's protocol ID
- EC/11/4/2025
- Other IDs
- 1/0558/25
- Status last verified
- May 2026
- First submitted
- 28 Mar 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schindera C, Weiss A, Hagenbuch N, Otth M, Diesch T, von der Weid N, Kuehni CE; Swiss Pediatric Oncology Group (SPOG). Physical activity and screen time in children who survived cancer: A report from the Swiss Childhood Cancer Survivor Study. Pediatr Blood Cancer. 2020 Feb;67(2):e28046. doi: 10.1002/pbc.28046. Epub 2019 Nov 20.
PubMed 31750617Li WHC, Ho KY, Lam KKW, Lam HS, Chui SY, Chan GCF, Cheung AT, Ho LLK, Chung OK. Adventure-based training to promote physical activity and reduce fatigue among childhood cancer survivors: A randomized controlled trial. Int J Nurs Stud. 2018 Jul;83:65-74. doi: 10.1016/j.ijnurstu.2018.04.007. Epub 2018 Apr 14.
PubMed 29689482Howell CR, Krull KR, Partin RE, Kadan-Lottick NS, Robison LL, Hudson MM, Ness KK. Randomized web-based physical activity intervention in adolescent survivors of childhood cancer. Pediatr Blood Cancer. 2018 Aug;65(8):e27216. doi: 10.1002/pbc.27216. Epub 2018 May 3.
PubMed 29722481Ho L, Li W, Cheung AT, Ho E, Lam K, Chiu SY, Chan G, Chung J. Relationships among hope, psychological well-being and health-related quality of life in childhood cancer survivors. J Health Psychol. 2021 Sep;26(10):1528-1537. doi: 10.1177/1359105319882742. Epub 2019 Oct 17.
PubMed 31621412Coombs A, Schilperoort H, Sargent B. The effect of exercise and motor interventions on physical activity and motor outcomes during and after medical intervention for children and adolescents with acute lymphoblastic leukemia: A systematic review. Crit Rev Oncol Hematol. 2020 Aug;152:103004. doi: 10.1016/j.critrevonc.2020.103004. Epub 2020 May 27.
PubMed 32580035
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a 12-week Virtual Buddy-movement Therapy on the Psychomotor and Social Development of Pediatric Oncology Patients in Remission
- ClinicalTrials.gov ID
- NCT07522905
- Acronym / sponsor ID
- EC/11/4/2025
- Keywords
- Pediatric Cancer Survivors, Acute Lymphoblastic Leukemia, Movement Therapy, Psychomotor development, Quality of life, BUDDY
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- National Institute of Children's Diseases, Slovakia, Scientific Grant Agency (VEGA) of Slovakia
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Buddy-Movement Therapy | Experimental | Behavioral: Virtual BUDDY-Movement TherapyThe 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. |
| No-intervention Control Group | No intervention | –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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in the movement program less than 80%
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 |
|---|---|---|
| Virtual BUDDY-Movement TherapyBuddy - 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. | Behavioural | Virtual Buddy-Movement Therapy |
Primary outcome
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.
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).
1 secondary outcome
Change in Body Mass Index (BMI)
Time frame: baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 31750617Schindera C, Weiss A, Hagenbuch N, Otth M, Diesch T, von der Weid N, Kuehni CE; Swiss Pediatric Oncology Group (SPOG). Physical activity and screen time in children who survived cancer: A report from the Swiss Childhood Cancer Survivor Study. Pediatr Blood Cancer. 2020 Feb;67(2):e28046. doi: 10.1002/pbc.28046. Epub 2019 Nov 20.
- Background: PubMed 29689482Li WHC, Ho KY, Lam KKW, Lam HS, Chui SY, Chan GCF, Cheung AT, Ho LLK, Chung OK. Adventure-based training to promote physical activity and reduce fatigue among childhood cancer survivors: A randomized controlled trial. Int J Nurs Stud. 2018 Jul;83:65-74. doi: 10.1016/j.ijnurstu.2018.04.007. Epub 2018 Apr 14.
- Background: PubMed 29722481Howell CR, Krull KR, Partin RE, Kadan-Lottick NS, Robison LL, Hudson MM, Ness KK. Randomized web-based physical activity intervention in adolescent survivors of childhood cancer. Pediatr Blood Cancer. 2018 Aug;65(8):e27216. doi: 10.1002/pbc.27216. Epub 2018 May 3.
- Background: PubMed 31621412Ho L, Li W, Cheung AT, Ho E, Lam K, Chiu SY, Chan G, Chung J. Relationships among hope, psychological well-being and health-related quality of life in childhood cancer survivors. J Health Psychol. 2021 Sep;26(10):1528-1537. doi: 10.1177/1359105319882742. Epub 2019 Oct 17.
- Background: PubMed 32580035Coombs A, Schilperoort H, Sargent B. The effect of exercise and motor interventions on physical activity and motor outcomes during and after medical intervention for children and adolescents with acute lymphoblastic leukemia: A systematic review. Crit Rev Oncol Hematol. 2020 Aug;152:103004. doi: 10.1016/j.critrevonc.2020.103004. Epub 2020 May 27.
- 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.
Adriana Kaplánová, PhD. principal investigator
Comenius University Bratislava, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual BUDDY-Movement Therapy in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by Comenius University at 1 site in Slovakia.
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 1 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: looking for participants now, as of the sponsor's last update on 7 May 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 Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriana Kaplánová, PhD. (+421908615773, adriana.kaplanova@uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 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 NCT07522905, which also lists 5 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 7 May 2026.