Spastic Diplegic Cerebral PalsyTL-CSB-CPNCT07808437
Therapeutic Listening for Balance and Trunk Control in Children With Cerebral Palsy
A study testing Conventional Training and Therapeutic Listening in people with Spastic Diplegic Cerebral Palsy and Cerebral Palsy, run by MTI University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy, Cerebral Palsy
- What is being tested?
- Conventional Training and Therapeutic Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2026to 10 Nov 2026
- Phase
- Interventional
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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Spastic Diplegic Cerebral Palsy, Cerebral Palsy
- Being tested
- Conventional Training, Therapeutic Listening
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TrainingOther
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 ListeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Conventional Training | Experimental | Structured core stability, traditional balance, and reaction-time training (35-50 min/session, 3 sessions/week for 8 weeks) Receives: 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. Receives: Behavioral: Therapeutic Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and immediately post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start28 Jun 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegic 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Samy Ibrahim, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808437
- Sponsor's protocol ID
- REC/211/MTI.PT/2606091
- Acronym
- TL-CSB-CP
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No