Design and Validation of a Personalized Preventive System for Adolescents Based on Biological Maturity, Body Composition, and Musculoskeletal Function.

NCT07385794 | Active Not Recruiting

• 2 other identifiers: UA-2025-12-13INNTA3/2025/8
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a personalized preventive physiotherapy and exercise program based on biological maturation status in adolescents aged 14 to 15 years. During adolescence, rapid growth and differences in biological maturation can increase the risk of musculoskeletal imbalances, pain, and injuries, especially in physically active youth. However, most preventive programs are designed according to chronological age rather than biological development. Participants will be assessed using non-invasive methods to determine biological maturation, body composition, and musculoskeletal function, including strength, balance, mobility, and postural control. Based on these assessments, participants in the intervention group will receive a 12-week individualized preventive physiotherapy program adapted to their maturation stage, while the control group will continue with their usual school or sports activities without structured intervention. The study will compare changes in musculoskeletal function, body composition, pain perception, and lifestyle-related variables between baseline and post-intervention assessments. The results are expected to provide evidence for a maturation-based preventive approach that can be applied in clinical, school, and sports settings to reduce injury risk and improve musculoskeletal health in adolescents.

Conditions

Musculoskeletal Health; Injury Prevention; Adolescent Growth and Development

Keywords

Adolescents; Biological maturation; Peak height velocity; Musculoskeletal function; Injury prevention; Physiotherapy; Preventive exercise; Physical development; Youth athletes

Outcome Measures

Primary Outcomes (2)

• Lower-limb Strength (Isometric)

  Change in lower-limb isometric strength assessed using digital dynamometry during standardized testing procedures.

  Baseline and 12 weeks

• Postural Balance

  Change in postural balance assessed using instrumented balance testing (e.g., force platform and inertial sensors) during standardized static and dynamic tasks.

  Baseline and 12 weeks

Secondary Outcomes (13)

• Mobility / Range of Motion

  Baseline and 12 weeks

• Postural Control

  Baseline and 12 weeks

• Core Stability / Core Control

  Baseline and 12 weeks

• Vertical Jump Performance

  Baseline and 12 weeks

• Fat Mass

  Baseline and 12 weeks

Study Arms (2)

Personalized Preventive Physiotherapy Program

EXPERIMENTAL

Participants in this arm will receive a personalized preventive physiotherapy and exercise program tailored to their biological maturation status and functional profile. The intervention will last 12 weeks and will include two supervised sessions per week focusing on neuromuscular control, strength development, mobility, balance, and postural stability. Periodic reassessments will allow individualized progression and adjustment of the program throughout the intervention period.

Behavioral: Personalized Preventive Physiotherapy and Exercise Program

Usual Activity Control Group

NO INTERVENTION

Participants in this arm will continue with their usual school and/or sports activities without receiving a structured preventive physiotherapy or exercise program. They will undergo the same baseline and post-intervention assessments as the intervention group for comparison purposes.

Interventions

Personalized Preventive Physiotherapy and Exercise Program BEHAVIORAL

This intervention consists of a personalized preventive physiotherapy and exercise program designed according to each participant's biological maturation status and functional assessment. The program lasts 12 weeks and includes two supervised sessions per week. Sessions focus on neuromuscular control, strength development, mobility, balance, core stability, and postural control. The intervention is individualized based on baseline and periodic reassessments, allowing progression and adjustment throughout the program. All sessions are supervised by qualified professionals.

Personalized Preventive Physiotherapy Program

Eligibility Criteria

• Age: 14 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents aged 14 to 15 years at the time of enrollment.
• Male and female participants.
• Apparently healthy adolescents without diagnosed chronic medical conditions.
• Participation in regular school physical education and/or organized sports activities.
• Ability to participate in moderate physical activity as determined by a pre-participation screening.
• Written informed consent obtained from parents or legal guardians, and assent from the participant.

You may not qualify if:

• Presence of acute or chronic musculoskeletal injury that limits participation in physical activity at the time of enrollment.
• History of musculoskeletal surgery within the previous 12 months.
• Diagnosed neurological, cardiovascular, metabolic, or systemic disease that contraindicates physical exercise.
• Current participation in another structured exercise or intervention study.
• Use of medication that may significantly affect musculoskeletal function or physical performance.
• Any condition that, in the opinion of the investigators, could compromise participant safety or adherence to the protocol.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

European Institute of Exercise and Health

Alicante, Elche, 03202, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Sciences

Model Details: Participants will be assigned to either a personalized preventive physiotherapy and exercise intervention group or a usual activity control group, and followed in parallel with pre- and post-intervention assessments.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)