- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07596745
Telerehabilitation-Based Dance Therapy in Pediatric Cancer
Effects of Telerehabilitation-Based Dance Therapy on Motor Proficiency, Quality of Life, Participation, and Motivation in Pediatric Cancer: A Randomized Controlled Trial
Childhood cancer requires prolonged and intensive treatment, resulting in significant biopsychosocial challenges for affected children and their families. During and following treatment, children frequently experience impairments in fine and gross motor skills, reduced physical capacity, emotional difficulties, and decreased participation in daily activities. Within the framework of the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY), these impairments in body structure and function may negatively influence activity, participation, and overall quality of life.
Dance therapy is a holistic rehabilitation approach that integrates rhythm, structured movement, and emotional expression to enhance motor performance, body awareness, and psychosocial well-being. Emerging evidence suggests that dance-based interventions may contribute to improved pain management, psychological resilience, and emotional health in pediatric oncology populations. However, access to structured physical activity programs remains limited due to treatment-related fatigue, infection risk, travel burden, time constraints, and financial costs.
Telerehabilitation may overcome these barriers by delivering therapy remotely, thereby improving accessibility, reducing logistical constraints, and ensuring continuity of care.
The aim of this randomized controlled trial is to evaluate the effects of an 8-week telerehabilitation-based dance therapy program (twice weekly, 35-40 minutes per session) on fine and gross motor skills, health-related quality of life, participation in home, school, and community settings, and motivation in children undergoing or recently completing cancer treatment.
Přehled studie
Postavení
Podmínky
Detailní popis
Children diagnosed with cancer frequently experience persistent biopsychosocial difficulties during and after treatment. Common symptoms include fatigue, pain, gastrointestinal disturbances, emotional distress, reduced motivation, and social isolation, all of which negatively affect health-related quality of life. In addition, both the disease process and treatment-related side effects may lead to impairments in fine and gross motor skills, thereby limiting activity performance and participation in daily life.
Rehabilitation and structured physical activity programs have been shown to be safe and beneficial for pediatric oncology populations, with positive effects on fatigue, physical functioning, and overall well-being. Dance therapy is a movement-based intervention that combines structured physical activity with rhythmic stimulation and emotional expression. It aims to enhance motor proficiency, body awareness, emotional regulation, and social participation. Although preliminary evidence suggests that dance- or music-based interventions may reduce anxiety and pain while improving mood in children with cancer, randomized controlled trials evaluating dance therapy as a structured exercise modality in pediatric oncology are lacking.
Access to in-person rehabilitation services may be restricted due to transportation challenges, financial burden, infection risk, and treatment-related fatigue. Telerehabilitation provides a feasible alternative by delivering remote, technology-supported therapy that improves accessibility, reduces logistical barriers, and promotes continuity of care. Emerging evidence indicates that telerehabilitation is both feasible and acceptable for children undergoing or completing cancer treatment.
This randomized controlled trial aims to evaluate the effectiveness of an 8-week telerehabilitation-based dance therapy program delivered twice weekly for 35-40 minutes per session. The primary focus is to assess changes in fine and gross motor proficiency. Secondary outcomes include participation in home, school, and community activities, health-related quality of life, and motivation. The study population consists of children aged 6-14 years with a history of childhood cancer who are undergoing or have recently completed treatment.
The intervention will be delivered via WhatsApp video calls as a medium-technology telerehabilitation model. Participant and caregiver feedback regarding feasibility and acceptability will also be collected to inform the future development of more advanced, personalized telerehabilitation systems.
Telerehabilitation-based dance therapy is expected to provide an accessible, enjoyable, and sustainable rehabilitation approach that supports functional recovery and enhances participation in daily life among children with cancer.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ozgun Kaya Kara, Assoc. Prof
- Telefonní číslo: +90 0242 310 66 13
- E-mail: ozgunkara@akdeniz.edu.tr
Studijní místa
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Antalya, Turecko (Türkiye), 07100
- Akdeniz University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Kontakt:
- Ozgun Kaya Kara, Assoc. Prof
- Telefonní číslo: +90 242 310 66 13
- E-mail: ozgunkara@akdeniz.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Children aged 6-14 years diagnosed with a hematological malignancy or solid tumor by a pediatric oncology specialist.
- Currently undergoing treatment or within 6 months after completion of treatment (for hematological malignancies: during maintenance therapy or ≤6 months post-treatment; for solid tumors: during treatment or ≤6 months post-treatment).
- Medically stable and cleared by the treating clinical team to participate in moderate physical activity/dance therapy.
- Able to stand independently and perform movements without assistive devices.
- Access to a digital device (smartphone, tablet, or computer) equipped with a camera, audio capability, and a stable internet connection.
- Parent/guardian able to read and write in Turkish.
- Written informed consent from the parent/guardian and assent from the child (as appropriate for age).
Exclusion Criteria:
- Pre-existing genetic, neurological, developmental, or motor disorders diagnosed prior to cancer diagnosis that may affect motor performance.
- Medical contraindications to exercise (e.g., unresolved fractures, severe avascular necrosis, recent bone marrow transplantation, or other conditions restricting physical activity as determined by the treating physician).
- Inability to maintain stable internet connectivity required for telerehabilitation sessions.
- Previous structured dance therapy participation within the last 6 months.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Experimental: Telerehabilitation-Based Dance Therapy Group
Participants allocated to the experimental group will receive dance therapy delivered via WhatsApp Messenger video calls.
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The intervention will be conducted twice weekly for 8 weeks, with each session lasting 35-40 minutes.
The program will include structured rhythmic movements, coordination exercises, balance activities, and creative movement components designed to improve fine and gross motor proficiency, body awareness, and participation.
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Aktivní komparátor: Active Comparator: Standard Physiotherapy and Rehabilitation Group
Participants in this group will receive a conventional physiotherapy and rehabilitation program delivered face-to-face.
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The program will be conducted twice weekly for 8 weeks. The standard physiotherapy program will consist of: Strengthening exercises Flexibility exercises Balance training Gait training Coordination exercises Each session will last approximately 35-40 minutes. |
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Žádný zásah: No Intervention Comparator: Usual Care Control Group
Participants in the control group will continue their usual daily activities and will not receive any structured physiotherapy or rehabilitation intervention during the 8-week study period.
After completion of the study assessments, participants in this group will be offered the standard physiotherapy program.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pediatric Quality of Life Inventory (PedsQL) Cancer Module
Časové okno: Change from baseline to the end of the 8-week intervention period
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The PedsQL Cancer Module is a validated instrument designed to assess health-related quality of life in children with cancer.
Both child self-report and parent proxy-report forms will be used, as appropriate for age.
The scale consists of 26 items across eight domains: pain, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication.
Items are scored on a 5-point Likert scale and transformed to a 0-100 scale, with higher scores indicating better quality of life.
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Change from baseline to the end of the 8-week intervention period
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Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2 SF)
Časové okno: Change from baseline to the end of the 8-week intervention period
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The BOT-2 SF is a norm-referenced assessment of fine and gross motor proficiency for children aged 4-21 years.
The short form consists of 14 items derived from the full version and evaluates fine manual control, manual coordination, body coordination, strength, and agility.
Raw scores will be converted to standard scores and percentiles according to age norms.
Higher scores indicate better motor performance.
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Change from baseline to the end of the 8-week intervention period
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pediatric Motivation Scale (PMOT)
Časové okno: Change from baseline to the end of the 8-week intervention period
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The Pediatric Motivation Scale evaluates motivation to participate in rehabilitation programs in children aged 8-18 years.
The scale consists of 21 items across six domains: effort/importance, interest/enjoyment, competence, relatedness, autonomy, and value/usefulness.
The first 19 items are rated on a 6-point Likert scale, with higher scores indicating greater motivation.
Items 20 and 21 are open-ended and will be descriptively analyzed.
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Change from baseline to the end of the 8-week intervention period
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Participation and Environment Measure for Children and Youth (PEM-CY)
Časové okno: Change from baseline to the end of the 8-week intervention period
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The PEM-CY is a parent-report questionnaire assessing participation and environmental factors in home, school, and community settings.
It includes 25 activity types (10 home, 5 school, 10 community).
For each activity, parents report participation frequency, level of involvement (5-point scale), and whether change is desired.
Higher participation frequency and involvement scores indicate greater participation.
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Change from baseline to the end of the 8-week intervention period
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Abu-Odah H, Wang M, Su JJ, Collard-Stokes G, Sheffield D, Molassiotis A. Effectiveness of dance movement therapy and dance movement interventions on cancer patients' health-related outcomes: a systematic review and meta-analysis. Support Care Cancer. 2024 Mar 19;32(4):235. doi: 10.1007/s00520-024-08431-4.
- Tortora S. Children Are Born to Dance! Pediatric Medical Dance/Movement Therapy: The View from Integrative Pediatric Oncology. Children (Basel). 2019 Jan 21;6(1):14. doi: 10.3390/children6010014.
- Melesse TG, Chau JPC, Nan MA. Effectiveness of psychosocial interventions on health outcomes of children with cancer: A systematic review of randomised controlled trials. Eur J Cancer Care (Engl). 2022 Nov;31(6):e13695. doi: 10.1111/ecc.13695. Epub 2022 Aug 25.
- Madden JR, Mowry P, Gao D, Cullen PM, Foreman NK. Creative arts therapy improves quality of life for pediatric brain tumor patients receiving outpatient chemotherapy. J Pediatr Oncol Nurs. 2010 May-Jun;27(3):133-45. doi: 10.1177/1043454209355452.
- Lambert G, Alos N, Bernier P, Laverdiere C, Drummond K, Dahan-Oliel N, Lemay M, Veilleux LN, Kairy D. Patient and Parent Experiences with Group Telerehabilitation for Child Survivors of Acute Lymphoblastic Leukemia. Int J Environ Res Public Health. 2021 Mar 31;18(7):3610. doi: 10.3390/ijerph18073610.
- Ozdemir Koyu H, Kilicarslan Toruner E. The effect of technology-based interventions on child and parent outcomes in pediatric oncology: A systemic review of experimental evidence. Asia Pac J Oncol Nurs. 2023 Mar 30;10(5):100219. doi: 10.1016/j.apjon.2023.100219. eCollection 2023 May.
- Henry J, Leprince T, Garcia Robles S, Famery A, Boyle H, Gilis L, Witz C, Barland JC, Blay JY, Marec-Berard P. Qualitative, Exploratory, and Multidimensional Study of Telepresence Robots for Overcoming Social Isolation of Children and Adolescents Hospitalized in Onco-Hematology. J Adolesc Young Adult Oncol. 2020 Feb;9(1):90-95. doi: 10.1089/jayao.2019.0059. Epub 2019 Oct 30.
- Grimshaw SL, Taylor NF, Mechinaud F, Conyers R, Shields N. Physical activity for children undergoing acute cancer treatment: A qualitative study of parental perspectives. Pediatr Blood Cancer. 2020 Jun;67(6):e28264. doi: 10.1002/pbc.28264. Epub 2020 Apr 11.
- Camden C, Silva M. Pediatric Teleheath: Opportunities Created by the COVID-19 and Suggestions to Sustain Its Use to Support Families of Children with Disabilities. Phys Occup Ther Pediatr. 2021;41(1):1-17. doi: 10.1080/01942638.2020.1825032. Epub 2020 Oct 6.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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