CancerNCT07301684
Physiotherapy in Pediatric Oncology
A study testing Therapeutic physical exercise, Therapeutic physical exercise + electrotherapy and Therapeutic physical exercise + gamified game in people with Cancer, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Therapeutic physical exercise, Therapeutic physical exercise + electrotherapy and Therapeutic physical exercise + gamified game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to Nov 2026
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Therapeutic physical exercise, Therapeutic physical exercise + electrotherapy, Therapeutic physical exercise + gamified game
- Keywords
- pediatrics, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic physical exerciseOther
Specific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises.
Therapeutic physical exercise + electrotherapyOther
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.
Therapeutic physical exercise + gamified gameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP EXERCISE | Active comparator | Not described Receives: Other: Therapeutic physical exercise |
| GROUP ELECTROTHERAPY | Active comparator | Not described Receives: Other: Therapeutic physical exercise + electrotherapy |
| GROUP EXERGAMING | Active comparator | Not described Receives: Other: Therapeutic physical exercise + gamified game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Lower-limb 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.
Upper-limb strength: Handgrip strength measured using a Stabilizer pressure biofeedback device: is a measure of upper-limb isometric strength in which the participant compresses the pressure device with the hand to generate the maximum possible pressure. The assessment is performed separately for the right and left hands, and the maximum pressure generated is recorded in millimeters of mercury (mmHg). Higher values indicate greater handgrip strength.
Measured: 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.
Measured: 6 month
Physical activity self-efficacy
Physical Activity Self-Efficacy Scale (AEF): is a self-report measure designed to assess the participant's perceived confidence in their ability to engage in physical activity. The scale evaluates how capable the child or adolescent feels of performing physical activity in different situations. If reported using a numerical score, the total score ranges from 0 to 10, where 0 represents the lowest level of perceived self-efficacy and 10 represents the highest level. Higher scores indicate greater perceived self-efficacy for physical activity.
Measured: 6 month
Pain level
Visual Analog Scale (VAS) and Chronic Pain Grade Scale (CPGS): pain is assessed using complementary measures of pain intensity and its impact. The VAS is a simple, widely used measure for assessing subjective pain intensity. It typically consists of a 10-centimeter horizontal line anchored by verbal descriptors at each end, from 0 = "no pain" to 10 = "worst imaginable pain." The respondent marks the point that best represents their perceived pain intensity. The CPGS is used to assess chronic pain severity, considering pain intensity and its associated impact on daily functioning. When pain intensity is reported numerically, scores range from 0 to 10, with 0 representing no pain and 10 representing the highest pain intensity. Higher scores indicate greater pain severity and impact.
Measured: 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.
Measured: 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.
Measured: 6 month
Weight
Tanita DC-430 MA
Measured: 6 month
Height
Harpender stadiometer
Measured: 6 month
BMI
weight/height 2
Measured: 6 month
Muscle circumferences (upper arm, waist, hip, and thigh)
Tape measure
Measured: 6 month
Secondary outcomes (7)
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.
Measured: 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.
Measured: 6 month
Anxiety-depressive symptoms
Depressive and anxiety 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 a minimum total score of 0 and a maximum total score of 54. Higher scores indicate more severe depressive symptoms.
The Childhood Anxiety Sensitivity Index (CASI) is a self-report measure that evaluates 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 0 and a maximum of 54. Higher scores reflect greater anxiety sensitivity.
The State-Trait Anxiety Inventory for Children (STAIC) is a self-report questionnaire designed to assess anxiety in children and adolescents through two separate dimensions: state anxiety, which reflects transient anxiety experienced at a particular moment, and trait anxiety, which reflects a relatively stable tendency to ex
Measured: 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.
Measured: 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 11 and a maximum of 44. Higher scores indicate greater kinesiophobia, reflecting a stronger fear of movement or activity due to pain or injury.
Measured: 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.
Measured: 6 month
Social Support
Social support: The Social Support Questionnaire for Children (SAQ-C24) is a self-report questionnaire designed to assess perceived social support in children and adolescents across relevant interpersonal and social contexts. It consists of 24 items, providing a total score ranging from 0 to 96. Higher scores indicate greater difficulties or poorer perceived social support, whereas lower scores reflect a more favorable perception of social support.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Mar 2026
- Primary completion30 Apr 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three intervention arms: 1. Therapeutic physical exercise 2. Therapeutic physical exercise + electrotherapy 3. Therapeutic physical exercise + gamified game
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Linero Bocanegra, University of Seville
- Investigators
- MANOLO M ALBORNOZ CABELLO, FISIOTERAPEUTA, Principal investigator, FACULTAD DE ENFERMERÓIA, FISIOTERAPIA Y PODOLOGÍA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301684
- Sponsor's protocol ID
- 01
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of a Multimodal Physiotherapy Treatment in Pediatric and Adolescent Cancer Survivors: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07301684
- Acronym / sponsor ID
- 01
- Conditions
- Cancer
- Keywords
- pediatrics, oncology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three intervention arms: 1. Therapeutic physical exercise 2. Therapeutic physical exercise + electrotherapy 3. Therapeutic physical exercise + gamified game
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Therapeutic physical exerciseSpecific therapeutic exercise intervention based on FITT parameters and working with aerobic, anaerobic, and breathing exercises. | Other | GROUP EXERCISE |
| Therapeutic physical exercise + electrotherapySpecific 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. | Other | GROUP ELECTROTHERAPY |
| Therapeutic physical exercise + gamified gameSpecific 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. | Other | GROUP EXERGAMING |
Primary outcome
Strength
Time frame: 6 month
Lower-limb 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. Upper-limb strength: Handgrip strength measured using a Stabilizer pressure biofeedback device: is a measure of upper-limb isometric strength in which the participant compresses the pressure device with the hand to generate the maximum possible pressure. The assessment is performed separately for the right and left hands, and the maximum pressure generated is recorded in millimeters of mercury (mmHg). Higher values indicate greater handgrip strength.
Cardiorespiratory function
Time frame: 6 month
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.
Physical activity self-efficacy
Time frame: 6 month
Physical Activity Self-Efficacy Scale (AEF): is a self-report measure designed to assess the participant's perceived confidence in their ability to engage in physical activity. The scale evaluates how capable the child or adolescent feels of performing physical activity in different situations. If reported using a numerical score, the total score ranges from 0 to 10, where 0 represents the lowest level of perceived self-efficacy and 10 represents the highest level. Higher scores indicate greater perceived self-efficacy for physical activity.
Pain level
Time frame: 6 month
Visual Analog Scale (VAS) and Chronic Pain Grade Scale (CPGS): pain is assessed using complementary measures of pain intensity and its impact. The VAS is a simple, widely used measure for assessing subjective pain intensity. It typically consists of a 10-centimeter horizontal line anchored by verbal descriptors at each end, from 0 = "no pain" to 10 = "worst imaginable pain." The respondent marks the point that best represents their perceived pain intensity. The CPGS is used to assess chronic pain severity, considering pain intensity and its associated impact on daily functioning. When pain intensity is reported numerically, scores range from 0 to 10, with 0 representing no pain and 10 representing the highest pain intensity. Higher scores indicate greater pain severity and impact.
Balance
Time frame: 6 month
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.
Ankle dorsiflexion ROM
Time frame: 6 month
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.
Weight
Time frame: 6 month
Tanita DC-430 MA
Height
Time frame: 6 month
Harpender stadiometer
BMI
Time frame: 6 month
weight/height 2
Muscle circumferences (upper arm, waist, hip, and thigh)
Time frame: 6 month
Tape measure
7 secondary outcomes
Cancer-related fatigue
Time frame: 6 month
Cancer-related Quality of life
Time frame: 6 month
Anxiety-depressive symptoms
Time frame: 6 month
Sleep
Time frame: 6 month
Kinesiophobia
Time frame: 6 month
Treatment Adherence
Time frame: 6 month
Social Support
Time frame: 6 month
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 23 Oct 2026.
- 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. This study is not recruiting at the moment.
MANOLO M ALBORNOZ CABELLO, FISIOTERAPEUTA principal investigator
FACULTAD DE ENFERMERÓIA, FISIOTERAPIA Y PODOLOGÍA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic physical exercise, Therapeutic physical exercise + electrotherapy and Therapeutic physical exercise + gamified game in people with Cancer, run by University of Seville at 1 site in Spain.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 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 Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: 6 month). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.