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

NCT07808437 | Active Not Recruiting

• 1 other identifier: REC/211/MTI.PT/2606091
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spastic Diplegic Cerebral Palsy; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Pediatric Balance Scale (PBS) Score

  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

  Baseline and immediately post-intervention (8 weeks)

Study Arms (2)

Group A: Conventional Training

EXPERIMENTAL

Structured core stability, traditional balance, and reaction-time training (35-50 min/session, 3 sessions/week for 8 weeks)

Other: Conventional Training

Group B: Therapeutic Listening

EXPERIMENTAL

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.

Behavioral: Therapeutic Listening

Interventions

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.

Group B: Therapeutic Listening

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)

Group A: Conventional Training

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Faculty of Physical Therapy MTI University

Cairo, 3753450, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The manuscript specifies that only the outcome assessor was blinded to group allocation, while participants and treating therapists (care providers/investigators) were not blinded due to the nature of the auditory intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of pediatric physical therapy

Model Details: Participants were randomly assigned in a 1:1 ratio to two parallel groups. Group A received core stability and traditional balance training, while Group B received the same training combined with Therapeutic Listening. Both groups received three sessions per week for 8 weeks.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

EG (1)