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Impact of Listening to Low Tones on Motor Function in Children With CP

NCT00394641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-11-13

No results posted yet for this study

Summary

The study aims to evaluate the impact of a possible new treatment for hypertonia, contributing to the motor disability in children with cerebral palsy (CP).

This study follows a 2005-2006 pilot study, that demonstrate a significant motor improvement in 4 children exposed to low tones via stereophonic Headphones.(A possible mechanism is a deep brain stimulation outspreading from the auditory pathways in certain tones) The goal of this study is to perform a double blind randomized placebo-controlled trial (RCT) on 30 children.

A three-arm study, with one group receiving the proposed treatment-music with low tones and the other two groups receiving a placebo (music without tones or stories) will be performed.

clinical and a non invasive laboratory measurements (surface EMG) related to spasticity, active and passive range of movement, isometric strength and upper and lower body function would be measured both before and after the treatment .the assessments will include also a Visual assessment , evaluation of gaze coordination and a quality of life and a caretaker burden questionnaires.

Conditions

  • Cerebral Palsy
  • Hypertonia

Interventions

BEHAVIORAL

listening to music / stories via stereophonic headphones

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Adi Aran, DR · Sharee Zedek Medical Center , Jerusallem , Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00394641 on ClinicalTrials.gov