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Active, not recruiting

NCT Number: NCT07808437

Therapeutic Listening for Balance and Trunk Control in Children With Cerebral Palsy

This study evaluates whether adding Therapeutic Listening to a structured physiotherapy program can improve balance, trunk control, and reaction time in children with spastic diplegic cerebral palsy.

Children with spastic diplegic cerebral palsy may have difficulties with balance, trunk stability, and responding quickly to sensory cues. In this study, children will receive a structured program including core stability, balance, and reaction-time exercises. One group will receive the exercise program alone, while the other group will receive the same program together with Therapeutic Listening delivered through headphones during the exercise sessions.

The study will compare changes in balance, trunk control, and auditory reaction time between the two groups after 8 weeks of treatment. The study aims to determine whether Therapeutic Listening provides additional benefits when combined with conventional physiotherapy.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy MTI University

Cairo, 3753450, Egypt

About this study

Children with spastic diplegic cerebral palsy commonly experience difficulties with postural control, trunk stability, balance, and timely responses to sensory cues. These impairments may affect their ability to maintain stability, adapt to changes in the environment, and perform functional movements efficiently.

This randomized controlled trial is designed to investigate whether Therapeutic Listening can provide an additional therapeutic benefit when incorporated into a structured physiotherapy program. The study focuses on the potential contribution of auditory-based sensory input to functional motor performance during active rehabilitation.

The study compares a conventional rehabilitation program targeting core stability, balance, and reaction-time abilities with the same program delivered concurrently with Therapeutic Listening. The intervention period is 8 weeks, with treatment sessions provided three times per week.

The study will examine changes in balance, trunk control, and auditory reaction time following the intervention. The overall aim is to determine whether the addition of Therapeutic Listening enhances the effects of structured physiotherapy in children with spastic diplegic cerebral palsy.

The findings may help clarify the potential role of auditory-based sensory input as an adjunct to conventional pediatric physiotherapy and may provide information for future clinical research investigating multimodal rehabilitation approaches for children with cerebral palsy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed diagnosis of spastic diplegic cerebral palsy. Classified at Gross Motor Function Classification System (GMFCS) levels II or III. Lower-limb spasticity graded 1+ on the Modified Ashworth Scale (MAS). Ability to understand and follow simple verbal instructions. Medically stable condition.

Exclusion criteria

Severe cognitive impairment interfering with intervention or assessment. Presence of hearing impairment or auditory processing disorders. History of uncontrolled seizures. Recent orthopedic surgery. Botulinum toxin injection received within the past 6 months. Any other medical condition interfering with study intervention or outcome assessment.

Treatment and study plan

Conventional training

Other

Exercises performed 3 times per week for 8 weeks (35-50 min/session). Includes core stability training (prone-on-elbows, bridging, side-lying holds, therapy-ball reaching, pelvic tilting, trunk rotation), traditional balance training (tandem standing, single-leg stance, weight shifting, line walking, obstacle stepping, sit-to-stand), and reaction-time training (responding to verbal commands, ball catching/throwing, stepping to auditory cues)

Therapeutic Listening

Behavioral

Auditory-based sensory intervention utilizing electronically modified music tracks (Space, Rhythmic Connections, or Nature Winds) delivered via high-quality stereo headphones. Listening is administered concurrently during the 35-50 minute core stability and balance exercise sessions, 3 times per week for 8 weeks. Track selection is individualized according to each child's sensory-processing profile.

Primary outcomes

  1. Pediatric Balance Scale (PBS) Score

    Time frame: Baseline and immediately post-intervention (8 weeks)

    Assessment of sitting and standing balance performance. The PBS evaluates 14 balance tasks scored on a 0-4 scale, with total scores ranging from 0 to 56 (higher scores indicate better functional balance and postural control

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

Neurophysiological and Functional Effects of Therapeutic Listening on Core Stability, Reaction Timing, and Balance in Children With Diplegic Spastic Cerebral Palsy: A Randomized Controlled Trial

Acronym: TL-CSB-CP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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