AzTrials
AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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.

Spain1 site
  • Facultad de Enfermería, Fisioterapia y Podología

    Seville, 41006

Other trials in Spain

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 groups in NCT07301684
Study groupRoleWhat they receive
GROUP EXERCISEActive comparatorNot described
Receives: Other: Therapeutic physical exercise
GROUP ELECTROTHERAPYActive comparatorNot described
Receives: Other: Therapeutic physical exercise + electrotherapy
GROUP EXERGAMINGActive comparatorNot 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Weight

    Tanita DC-430 MA

    Measured: 6 month

  8. Height

    Harpender stadiometer

    Measured: 6 month

  9. BMI

    weight/height 2

    Measured: 6 month

  10. Muscle circumferences (upper arm, waist, hip, and thigh)

    Tape measure

    Measured: 6 month

Secondary outcomes (7)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted24 Dec 2025
  2. Study start1 Mar 2026
  3. Primary completion30 Apr 2026
  4. Study completionNov 2026 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in