Physiotherapy in Pediatric Oncology

NCT07301684 | Not Yet Recruiting

• 1 other identifier: 01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

pediatrics; oncology

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (8)

• Physical activity levels

  6 month

• Cancer-related fatigue

  6 month

• Cancer-related Quality of life

  6 month

• Anxiety-depressive symptoms

  6 month

• Sleep

  6 month

Study Arms (3)

GROUP EXERCISE

ACTIVE COMPARATOR

Other: Therapeutic physical exercise

GROUP ELECTROTHERAPY

ACTIVE COMPARATOR

Other: Therapeutic physical exercise + electrotherapy

GROUP EXERGAMING

ACTIVE COMPARATOR

Other: Therapeutic physical exercise + gamified game

Interventions

Therapeutic physical exercise OTHER

Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises.

GROUP EXERCISE

Therapeutic physical exercise + electrotherapy OTHER

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.

GROUP ELECTROTHERAPY

Therapeutic physical exercise + gamified game OTHER

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.

GROUP EXERGAMING

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville, Spain: collaborator
• University of Seville: lead

Study Sites (1)

Facultad de Enfermería, Fisioterapia y Podología

Seville, 41006, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• MANOLO M ALBORNOZ CABELLO, FISIOTERAPEUTA

  FACULTAD DE ENFERMERÓIA, FISIOTERAPIA Y PODOLOGÍA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MIRIAM MLB LINERO BOCANEGRA, FISIOTERAPEUTA

CONTACT

622150183; mlinerobocanegra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy

Model Details: Three intervention arms: 1. Therapeutic physical exercise 2. Therapeutic physical exercise + electrotherapy 3. Therapeutic physical exercise + gamified game

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 24, 2025
• Study Start: February 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)