Effects of an HABIT-ILE-Based Intervention in Children With Cerebral Palsy
ConditionCerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-13
SponsorUniversidad Europea de Madrid
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
HABIT-ILE
BehavioralParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Cerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mobExperimental treatment 1 intervention
Group B: Wait-List ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 15 days after, 6 months afterSecondary outcomes
1
Change in body composition
Change in body composition assessed using DEXA at Universidad Europea de Madrid.
Time frame
Baseline, 15 days after and 6 months after2
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).
Time frame
Baseline, 15 days after and 6 months after3
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
Time frame
Baseline, 15 days after, 6 months after4
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
Time frame
Baseline, 15 days after and 6 months afterLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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