Physiotherapy in Pediatric Oncology

Analysis of a Multimodal Physiotherapy Treatment in Pediatric and Adolescent Cancer Survivors: A Randomized Clinical Trial

The objective of this clinical trial is to determine whether therapeutic physical exercise combined with electrotherapy and exercise gaming improves rehabilitation outcomes in pediatric and adolescent cancer patients.

The main questions it aims to answer are:

Does the combination of therapeutic physical exercise plus muscle strengthening and therapeutic physical exercise plus gamification, compared to a single exercise intervention, improve patient condition? Does gamified exercise improve treatment adherence? Does electrotherapy improve muscle activity when used in muscle strengthening mode? Researchers will test the application of the described modalities and assess improvements in variables such as cardiorespiratory fitness, physical activity self-efficacy, pain, balance, joint range of motion, physical activity level, cancer-related fatigue, quality of life, anxiety-depression, sleep, kinesophobia, and social status.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Therapeutic physical exercise; Other: Therapeutic physical exercise + electrotherapy; Other: Therapeutic physical exercise + gamified game

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MIRIAM MLB LINERO BOCANEGRA, FISIOTERAPEUTA; Phone Number: +34 622150183; Email: mlinerobocanegra@gmail.com

Study Locations

• Spain
  • Seville, Spain, 41006
    • Facultad de Enfermería, Fisioterapia y Podología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have completed cancer treatment and are currently in remission, referred by their oncologist.
• Children and adolescents aged 3 to 16 years.
• Patients with a stable medical condition, without severe or acute complications related to cancer or its treatments.
• Patients whose informed consent (from parents/legal guardians, in this case, as they are minors) has been obtained to participate in this study.
• Patients with sufficient physical capacity to tolerate the activities proposed by the program.

Exclusion Criteria:

• Severe comorbidities: neuromuscular, cardiovascular, or respiratory diseases that prevent participation in the exercise program or interfere with the assessment of physical function.
• Incompatible medical treatments: patients currently receiving active treatments or with medical contraindications for electrotherapy or participation in exercise programs.
• Severe psychological issues: children with severe psychological disorders or cognitive disabilities that may hinder understanding and participation in the sessions.
• Visual impairments: patients with visual problems will not be able to participate, as this may interfere with the analysis of results related to the use of devices and video games for exercise.
• Participation in other clinical trials: patients already involved in other research that could interfere with the results of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GROUP EXERCISE	Other: Therapeutic physical exercise; Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises.
Active Comparator: GROUP ELECTROTHERAPY	Other: Therapeutic physical exercise + electrotherapy; Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises. Combined with the application of electrical waves for neurostimulation of the quadriceps muscles.
Active Comparator: GROUP EXERGAMING	Other: Therapeutic physical exercise + gamified game; Specific therapeutic exercise intervention based on FITT parameters and focusing on aerobic, anaerobic, and breathing exercises. Combined with the application of gamified exercise to improve treatment adherence in these young populations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	30-second sit-to-stand test to measure lower extremity muscle performance: is a functional measure of lower-limb strength in which an individual stands up and sits down from a chair as many times as possible within 30 seconds. If the test is reported using a numerical score, it corresponds to the total number of completed sit-to-stand repetitions, where the minimum value is 0, the maximum value depends on the person's performance, and higher scores indicate better lower-body strength and functional capacity.	6 month
Cardiorespiratory function	6-minute walk test: is a widely used assessment of cardiorespiratory function in which an individual is instructed to walk as far as possible along a flat, measured course for six minutes. When reported numerically, the score corresponds to the total distance walked in meters, with a minimum value of 0 meters, no fixed maximum (as it depends on individual performance), and higher distances indicating better cardiorespiratory capacity and endurance.	6 month
Physical activity self-efficacy	The five-item Physical Activity Self-Efficacy Scale (PASE): is a brief self-report measure that evaluates an individual's confidence in their ability to engage in physical activity under various challenging circumstances. Scores are obtained by summing responses to the five items, each typically rated on a scale from 1 (low confidence) to 5 (high confidence), yielding a minimum total score of 5 and a maximum of 25. Higher scores indicate better self-efficacy for maintaining physical activity.	6 month
Pain level	Visual Analog Scale (VAS): is a simple, widely used measure for assessing the intensity of subjective experiences such as pain, fatigue, or discomfort. It typically consists of a 10-centimeter horizontal line anchored by verbal descriptors at each end-for example, 0 = "no pain" and 10 = "worst imaginable pain." The respondent marks a point on the line that represents their perceived intensity. The minimum score is 0, the maximum score is 10, and higher scores indicate a worse symptom intensity.	6 month
Balance	Pediatric Berg Balance Scale (BBS): is a performance-based assessment designed to measure functional balance in children through 14 tasks such as standing, turning, and reaching. Each item is scored from 0 (inability to perform) to 4 (independent, best performance), producing a minimum total score of 0 and a maximum of 56. Higher scores indicate better balance ability and greater functional stability.	6 month
Ankle dorsiflexion ROM	Goniometer: is an instrument used to measure the range of motion (ROM) of a joint. For ankle dorsiflexion, the goniometer is positioned with the axis at the lateral malleolus, the stationary arm aligned with the fibula, and the movable arm along the fifth metatarsal. Measurements are reported in degrees, with a typical minimum of 0° and a maximum depending on the individual, usually around 20° for dorsiflexion. Higher values indicate greater ankle dorsiflexion ROM, reflecting better joint flexibility.	6 month
Weight	Tanita DC-439 MA	6 month
Height	Harpender stadiometer	6 month
BMI	weight/height 2	6 month
Bone mineral density	Ultrasound (QUS Model: Bone Mineral Densiometer, (OSTEOSYS, BETTER PRODUCTS FOR BETTER LIFE, n.d.))	6 month
Muscle circumferences (upper arm, waist, hip, and thigh)	Tape measure	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity levels	Accelerometry Test: is an objective method for assessing physical activity levels by having an individual wear an accelerometer device, usually on the wrist, hip, or ankle, which records movement intensity and duration. Data are typically reported as average counts per minute, steps per day, or minutes spent in different activity intensities (e.g., sedentary, light, moderate, vigorous). Minimum values can be 0, and the maximum depends on the individual's activity level. Higher values indicate greater levels of physical activity.	6 month
Cancer-related fatigue	PedsQL™ Multidimensional Fatigue Scale: is a self-report questionnaire designed to assess fatigue in children across three domains: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue. Items are scored on a 5-point Likert scale (0 = "Never" to 4 = "Almost Always"), which are then reverse-scored and transformed to a 0-100 scale, with higher scores indicating less fatigue and better functioning. The minimum total score is 0, the maximum is 100, and higher scores reflect lower fatigue levels.	6 month
Cancer-related Quality of life	PedsQL™ Pediatric Quality of Life Questionnaire (Spanish version for Children and Adolescents with Heart Disease (PedsQL™)): is a self-report instrument that assesses health-related quality of life across multiple domains, including physical, emotional, social, and school functioning. Items are rated on a 5-point Likert scale (0 = "Never" to 4 = "Almost Always"), which are then reverse-scored and transformed to a 0-100 scale. The minimum total score is 0, the maximum is 100, and higher scores indicate better health-related quality of life.	6 month
Anxiety-depressive symptoms	The Children's Depression Inventory (CDI): is a self-report questionnaire designed to assess depressive symptoms in children and adolescents aged 8 to 18 years. It consists of multiple items scored on a 0-2 scale, with the minimum total score of 0 and a maximum total score of 54. Higher scores indicate more severe depressive symptoms. Childhood Anxiety Sensitivity Index (CASI): is a self-report measure that evaluates the fear of anxiety-related sensations in children. Items are rated on a 3-point scale (1 = "None" to 3 = "A lot"), with a minimum total score of 18 and a maximum of 54. Higher scores reflect greater anxiety sensitivity.	6 month
Sleep	Pediatric Sleep Questionnaire (PSQ): is a parent- or caregiver-reported tool used to screen for sleep-related problems in children, including sleep-disordered breathing, snoring, and daytime sleepiness. Items are typically scored as "Yes" = 1, "No" = 0, or "Don't know" = missing. The total score is calculated as the proportion of positive responses, with a minimum of 0 and a maximum of 1. Higher scores indicate more sleep-related problems.	6 month
Kinesiophobia	Kinesiophobia Questionnaire for Children (KQC) adapted from the Tampa Scale for Kinesiophobia (TSK): is a self-report instrument designed to assess fear of movement or reinjury in children. Items are typically scored on a 4-point Likert scale (1 = "Strongly Disagree" to 4 = "Strongly Agree"), with a minimum total score of 13 and a maximum of 52. Higher scores indicate greater kinesiophobia, reflecting a stronger fear of movement or activity due to pain or injury.	6 month
Treatment Adherence	Exercise Adherence Rating Scale: is a self-report questionnaire used to assess an individual's adherence to prescribed exercise programs. Items are typically scored on a 5-point Likert scale (0 = "Completely Disagree" to 4 = "Completely Agree"), with a minimum total score of 0 and a maximum of 24 for the adherence section. Higher scores indicate better adherence to the exercise regimen.	6 month
Social Support	Social Support Questionnaire for Children (SSQ-C): is a self-report instrument designed to assess the perceived availability and satisfaction with social support in children. It includes items asking about the number of supportive people (availability) and satisfaction with support. Scores are typically summarized as average number of supporters per item and average satisfaction rating, with minimum values of 0 and maximum values depending on the scale used for satisfaction (often 6 or 7). Higher scores indicate greater perceived social support and satisfaction.	6 month

Collaborators and Investigators

• Sponsor: University of Seville
• Collaborators: University of Seville, Spain
• Investigators: Principal Investigator: MANOLO M ALBORNOZ CABELLO, FISIOTERAPEUTA, FACULTAD DE ENFERMERÓIA, FISIOTERAPIA Y PODOLOGÍA

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Estimated): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pediatrics; oncology
• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy
• Other Study ID Numbers: 01 (Miami VAHS)

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