Cerebral PalsyUEM-HABITILENCT07506837
Effects of an HABIT-ILE-Based Intervention in Children With Cerebral Palsy
A study testing HABIT-ILE in people with Cerebral Palsy, run by Universidad Europea de Madrid.
Trial summary
This interventional study will evaluate the effects of an intensive HABIT-ILE-based camp on cardiorespiratory measures and body composition in children with cerebral palsy. Although intensive motor control-based therapies such as HABIT/HABIT-ILE have shown functional benefits, the novelty of this study is the… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- HABIT-ILE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 Jan 2028
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a diagnosis of cerebral palsy (hemiparesis or diparesis).
- Age 6 to 13 years.
- Moderate cognitive impairment or cognitive status compatible with the ability to follow verbal instructions.
- Ability to participate in an intensive summer camp-format rehabilitation program.
- Parent/legal guardian able to provide informed consent and complete parent-/tutor-reported outcome measures.
Who cannot join
- Medical or orthopedic condition that contraindicates participation in intensive physical rehabilitation activities.
- Unstable neurological or medical condition (e.g., uncontrolled seizures) that may interfere with safe participation.
- Severe cognitive or behavioral impairment preventing comprehension of basic verbal instructions or safe participation in group activities.
- Contraindication to study assessment procedures, including physiological testing or DEXA body composition assessment.
- Participation in another concurrent intensive rehabilitation program during the study comparison period.
- Any condition that, in the investigators' judgment, may compromise safety, adherence, or outcome assessment validity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Intensive Motor Control-Based Therapy for Upper and Lower Extremities in Children With Cerebral Palsy
This interventional study will evaluate the effects of an intensive HABIT-ILE-based camp on cardiorespiratory measures and body composition in children with cerebral palsy. Although intensive motor control-based therapies such as HABIT/HABIT-ILE have shown functional benefits, the novelty of this study is the assessment of energy expenditure during functional tasks and post-intervention changes in body composition. Participants will attend a summer camp-format intervention delivering 90 hours of upper and lower extremity training over 15 days (6 hours/day), supervised by trained rehabilitation staff in a playful, progressive group setting. The program includes bimanual activities, gait and stair tasks, functional strengthening, and whole-body games, with fatigue prevention strategies.Assessments will be performed at baseline and immediately after the camp in July 2027, with follow-up at 6 months (January 2028). Outcomes include functional performance, parent-reported function, low-intensity task-related energy expenditure measured in a physiology laboratory, and body composition measured by DEXA at Universidad Europea de Madrid
Read the detailed description
Children with cerebral palsy frequently present limitations in upper and lower extremity function that affect mobility, daily activities, and participation. Intensive motor control-based approaches, particularly Hand-Arm Bimanual Intensive Therapy (HABIT) and Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE), have shown functional benefits in this population. In prior HABIT/HABIT-ILE programs, improvements in upper limb function have been reported, and benefits may persist over time after the intervention. In addition to motor impairment, children with cerebral palsy may be especially vulnerable to sedentary behavior and related health consequences. The present study is based on the rationale that intensive whole-body functional training may improve not only motor performance but also physiological efficiency during functional tasks. The main novelty of this study is not the intervention format itself, but the evaluation of task-related energy expenditure and post-intervention body composition changes after an intensive HABIT-ILE-based summer camp.This study will implement a summer camp-format intensive intervention in children with cerebral palsy, modeled on previously implemented intensive camp experiences. Participants will receive 90 hours of therapy over 15 days (6 hours/day), delivered by trained interventionists (physiotherapists, occupational therapists, supervised students, and volunteers under professional supervision). The intervention will include bimanual upper limb activities; lower extremity and mobility training (e.g., walking on different surfaces, treadmill walking, stair negotiation); functional strengthening through activity-based tasks; and whole-body playful activities (e.g., dance and sports games), with progressive difficulty tailored to each child's performance. Activities will be delivered in small groups (approximately 4-6 children) to promote motivation and peer interaction, and the program will be organized to prevent excessive fatigue.Outcome assessments will include functional measures for upper and lower extremity performance and parent-/tutor-reported functional perception. The protocol also includes low-intensity task-related energy expenditure assessment using physiological monitoring (gas analysis and electrocardiographic monitoring during functional tasks such as comfortable walking) in the physiology laboratory, and body composition assessment using DEXA at Universidad Europea de Madrid. Assessments will be performed at baseline and immediately after the camp in July 2027, with follow-up assessments at 6 months (January 2028). To improve measurement consistency, pre/post testing will be performed by the same evaluator, and test sessions may be recorded for review; the evaluator is intended to be blinded to the intervention.
- Conditions
- Cerebral Palsy
- Being tested
- HABIT-ILE
- Keywords
- Cerebral Palsy, HABIT-ILE, Body Composition, Energy Expenditure
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HABIT-ILEBehavioural
Participants will receive a 90-hour intensive intervention (6 hours/day for 15 days) in a summer camp format. The intervention includes bimanual upper-limb activities; lower-extremity and mobility training (e.g., walking on different surfaces, treadmill walking, stair negotiation); activity-based strengthening; and whole-body playful activities (e.g., dance and sports games). New technologies (e.g., videogame-based activities and robot-assisted activities) may be incorporated within a participatory and progressively challenging framework. The intervention will be delivered in small groups (approximately 4 to 6 children) by trained physiotherapists, occupational therapists, supervised students, and volunteers. The intervention schedule will be planned to avoid excessive fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mob | Experimental | Children with cerebral palsy will participate in a summer camp-format intensive rehabilitation program based on HABIT-ILE principles. The intervention includes upper and lower extremity motor training delivered in a playful, progressive group setting by trained interventionists under professional supervision. The program is administered over 15 days, 6 hours/day (90 total hours), with activities adapted to participant performance and fatigue prevention strategies. Receives: Behavioral: HABIT-ILE |
| Wait-List Control | No intervention | Children with cerebral palsy assigned to the wait-list control group will not receive the intensive HABIT-ILE-based summer camp intervention during the initial study comparison period. They will continue with their usual care and will be offered participation in the camp intervention next year, according to program availability and study logistics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in task-related energy expenditure during low-intensity functional activity
Change in energy expenditure during low-intensity functional tasks (e.g., comfortable walking), assessed in the physiology laboratory using gas analysis and electrocardiographic monitoring during task performance.
Measured: Baseline, 15 days after, 6 months after
Secondary outcomes (12)
Change in body composition
Change in body composition assessed using DEXA at Universidad Europea de Madrid.
Measured: Baseline, 15 days after and 6 months after
Change in manual function (Assisting Hand Assessment, AHA)
Change in effectiveness of use of the affected hand during bimanual performance, assessed with the Assisting Hand Assessment (AHA).
Measured: Baseline, 15 days after and 6 months after
Change in unilateral hand function performance (Jebsen-Taylor Test of Hand Function)
Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function
Measured: Baseline, 15 days after, 6 months after
Change in walking capacity (6-Minute Walk Test)
Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function
Measured: Baseline, 15 days after and 6 months after
Change in gait speed (10-Meter Walk Test)
Change in gait speed, assessed by time required to walk 10 meters during the 10-Meter
Measured: Baseline, 15 days after and 6 months after
Change in functional mobility (Timed Up and Go)
Change in functional mobility, assessed by the Timed Up and Go test (time required to stand up, walk, turn, return, and sit down)
Measured: Baseline, 15 days after, 6 months after
Change in gross motor function (GMFM)
Change in gross motor function (GMFM)
Measured: Baselilne, 15 days after, 6 months after
Change in functional balance (Pediatric Balance Scale)
Change in functional balance (Pediatric Balance Scale)
Measured: Baseline, 15 days after and 1 month after
Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM)
Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM)
Measured: Baseline, 15 days after, 6 months after
Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI)
Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI)
Measured: Baseline, 15 days after, 6 months after
Change in parent-reported manual ability ABILHAND-Kids)
Change in parent-reported manual ability (ABILHAND-Kids )
Measured: Baseline, 15 days after and 6 months after
Change in parent-reported locomotion difficulty (ABILOCO-Kids)
Change in parent-reported locomotion difficulty (ABILOCO-Kids)
Measured: Baseline, 15 days after and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanesa Abuín, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506837
- Sponsor's protocol ID
- UEM-HABITILE-CAMP
- Acronym
- UEM-HABITILE
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bleyenheuft Y, Dricot L, Gilis N, Kuo HC, Grandin C, Bleyenheuft C, Gordon AM, Friel KM. Capturing neuroplastic changes after bimanual intensive rehabilitation in children with unilateral spastic cerebral palsy: A combined DTI, TMS and fMRI pilot study. Res Dev Disabil. 2015 Aug-Sep;43-44:136-49. doi: 10.1016/j.ridd.2015.06.014. Epub 2015 Jul 13.
PubMed 26183338Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.
PubMed 25527487Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.
PubMed 21700924Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.
PubMed 17979861Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
PubMed 17044964
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Motor Control-Based Therapy for Upper and Lower Extremities in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07506837
- Acronym / sponsor ID
- UEM-HABITILE / UEM-HABITILE-CAMP
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, HABIT-ILE, Body Composition, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 2 Apr 2026 (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.
This interventional study will evaluate the effects of an intensive HABIT-ILE-based camp on cardiorespiratory measures and body composition in children with cerebral palsy. Although intensive motor control-based therapies such as HABIT/HABIT-ILE have shown functional benefits, the novelty of this study is the assessment of energy expenditure during functional tasks and post-intervention changes in body composition. Participants will attend a summer camp-format intervention delivering 90 hours of upper and lower extremity training over 15 days (6 hours/day), supervised by trained rehabilitation staff in a playful, progressive group setting. The program includes bimanual activities, gait and stair tasks, functional strengthening, and whole-body games, with fatigue prevention strategies.Assessments will be performed at baseline and immediately after the camp in July 2027, with follow-up at 6 months (January 2028). Outcomes include functional performance, parent-reported function, low-intensity task-related energy expenditure measured in a physiology laboratory, and body composition measured by DEXA at Universidad Europea de Madrid
Detailed description
Children with cerebral palsy frequently present limitations in upper and lower extremity function that affect mobility, daily activities, and participation. Intensive motor control-based approaches, particularly Hand-Arm Bimanual Intensive Therapy (HABIT) and Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE), have shown functional benefits in this population. In prior HABIT/HABIT-ILE programs, improvements in upper limb function have been reported, and benefits may persist over time after the intervention. In addition to motor impairment, children with cerebral palsy may be especially vulnerable to sedentary behavior and related health consequences. The present study is based on the rationale that intensive whole-body functional training may improve not only motor performance but also physiological efficiency during functional tasks. The main novelty of this study is not the intervention format itself, but the evaluation of task-related energy expenditure and post-intervention body composition changes after an intensive HABIT-ILE-based summer camp.This study will implement a summer camp-format intensive intervention in children with cerebral palsy, modeled on previously implemented intensive camp experiences. Participants will receive 90 hours of therapy over 15 days (6 hours/day), delivered by trained interventionists (physiotherapists, occupational therapists, supervised students, and volunteers under professional supervision). The intervention will include bimanual upper limb activities; lower extremity and mobility training (e.g., walking on different surfaces, treadmill walking, stair negotiation); functional strengthening through activity-based tasks; and whole-body playful activities (e.g., dance and sports games), with progressive difficulty tailored to each child's performance. Activities will be delivered in small groups (approximately 4-6 children) to promote motivation and peer interaction, and the program will be organized to prevent excessive fatigue.Outcome assessments will include functional measures for upper and lower extremity performance and parent-/tutor-reported functional perception. The protocol also includes low-intensity task-related energy expenditure assessment using physiological monitoring (gas analysis and electrocardiographic monitoring during functional tasks such as comfortable walking) in the physiology laboratory, and body composition assessment using DEXA at Universidad Europea de Madrid. Assessments will be performed at baseline and immediately after the camp in July 2027, with follow-up assessments at 6 months (January 2028). To improve measurement consistency, pre/post testing will be performed by the same evaluator, and test sessions may be recorded for review; the evaluator is intended to be blinded to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mob | Experimental | Behavioral: HABIT-ILEChildren with cerebral palsy will participate in a summer camp-format intensive rehabilitation program based on HABIT-ILE principles. The intervention includes upper and lower extremity motor training delivered in a playful, progressive group setting by trained interventionists under professional supervision. The program is administered over 15 days, 6 hours/day (90 total hours), with activities adapted to participant performance and fatigue prevention strategies. |
| Wait-List Control | No intervention | –Children with cerebral palsy assigned to the wait-list control group will not receive the intensive HABIT-ILE-based summer camp intervention during the initial study comparison period. They will continue with their usual care and will be offered participation in the camp intervention next year, according to program availability and study logistics. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with a diagnosis of cerebral palsy (hemiparesis or diparesis).
- Age 6 to 13 years.
- Moderate cognitive impairment or cognitive status compatible with the ability to follow verbal instructions.
- Ability to participate in an intensive summer camp-format rehabilitation program.
- Parent/legal guardian able to provide informed consent and complete parent-/tutor-reported outcome measures.
Key exclusion criteria (6 listed)
- Medical or orthopedic condition that contraindicates participation in intensive physical rehabilitation activities.
- Unstable neurological or medical condition (e.g., uncontrolled seizures) that may interfere with safe participation.
- Severe cognitive or behavioral impairment preventing comprehension of basic verbal instructions or safe participation in group activities.
- Contraindication to study assessment procedures, including physiological testing or DEXA body composition assessment.
- Participation in another concurrent intensive rehabilitation program during the study comparison period.
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 |
|---|---|---|
| HABIT-ILEParticipants will receive a 90-hour intensive intervention (6 hours/day for 15 days) in a summer camp format. The intervention includes bimanual upper-limb activities; lower-extremity and mobility training (e.g., walking on different surfaces, treadmill walking, stair negotiation); activity-based strengthening; and whole-body playful activities (e.g., dance and sports games). New technologies (e.g., videogame-based activities and robot-assisted activities) may be incorporated within a participatory and progressively challenging framework. The intervention will be delivered in small groups (approximately 4 to 6 children) by trained physiotherapists, occupational therapists, supervised students, and volunteers. The intervention schedule will be planned to avoid excessive fatigue. | Behavioural | Cerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mob |
Primary outcome
Change in task-related energy expenditure during low-intensity functional activity
Time frame: Baseline, 15 days after, 6 months after
Change in energy expenditure during low-intensity functional tasks (e.g., comfortable walking), assessed in the physiology laboratory using gas analysis and electrocardiographic monitoring during task performance.
12 secondary outcomes
Change in body composition
Time frame: Baseline, 15 days after and 6 months after
Change in manual function (Assisting Hand Assessment, AHA)
Time frame: Baseline, 15 days after and 6 months after
Change in unilateral hand function performance (Jebsen-Taylor Test of Hand Function)
Time frame: Baseline, 15 days after, 6 months after
Change in walking capacity (6-Minute Walk Test)
Time frame: Baseline, 15 days after and 6 months after
Change in gait speed (10-Meter Walk Test)
Time frame: Baseline, 15 days after and 6 months after
Change in functional mobility (Timed Up and Go)
Time frame: Baseline, 15 days after, 6 months after
Change in gross motor function (GMFM)
Time frame: Baselilne, 15 days after, 6 months after
Change in functional balance (Pediatric Balance Scale)
Time frame: Baseline, 15 days after and 1 month after
Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM)
Time frame: Baseline, 15 days after, 6 months after
Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI)
Time frame: Baseline, 15 days after, 6 months after
Change in parent-reported manual ability ABILHAND-Kids)
Time frame: Baseline, 15 days after and 6 months after
Change in parent-reported locomotion difficulty (ABILOCO-Kids)
Time frame: Baseline, 15 days after and 6 months after
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 2 Apr 2026.
- Background: PubMed 26183338Bleyenheuft Y, Dricot L, Gilis N, Kuo HC, Grandin C, Bleyenheuft C, Gordon AM, Friel KM. Capturing neuroplastic changes after bimanual intensive rehabilitation in children with unilateral spastic cerebral palsy: A combined DTI, TMS and fMRI pilot study. Res Dev Disabil. 2015 Aug-Sep;43-44:136-49. doi: 10.1016/j.ridd.2015.06.014. Epub 2015 Jul 13.
- Background: PubMed 25527487Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.
- Background: PubMed 21700924Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.
- Background: PubMed 17979861Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.
- Background: PubMed 17044964Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing HABIT-ILE in people with Cerebral Palsy, run by Universidad Europea de Madrid.
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 6 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Vanesa Abuín ((+34) 912 115 224, vanesa.abuin@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in task-related energy expenditure during low-intensity functional activity (time frame: Baseline, 15 days after, 6 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07506837, which also lists 5 linked publications.
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 2 Apr 2026.