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

October 31, 2006 updated by: Shaare Zedek Medical Center

Impact of Listening to Low Tones Via Sterephonic Headphones on Hypertonia and Motor Function in Children With Cerebral Palsy- Randomized Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A pilot study we had done this year demonstrate a significant improvement in spasticity as measured clinically and by non invasive surface EMG, in four children with hypertonic CP, exposed to music combined with low frequency tones, via stereophonic headphones. Two children demonstrated a prompt motor improvement also.

The goal of this study is to perform a double blind randomized placebo-controlled trial (RCT) to assess these preliminary results.

participants: 30 children with moderate to severe hypertonic CP (GMFCS 3-5), aged 3-9 years, from the "Meshy" or "Ilanot" Early Childhood Development Centers - Jerusalem, Israel, will be recruited with parents informed consent. Children who refuse to put on the headphones will not be included.

A randomized controlled 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.

The children will listen to the music / stories via stereophonic headphones for 10 minutes - 3 times a week for 4 weeks.

Before starting the treatment the children will undergo:

  1. Neurological evaluation with their medical charts.
  2. Physiotherapic evaluation using the GMFM assessment and a surface EMG
  3. Fine motor assessment using the QUEST and visual assessments.
  4. Parents will complete the PODCI and the Care and Comfort questionnaires.

We will repeat the EMG measurements immediately after the treatment.

3 months after completing the treatment we will repeat the measurements we had done before treatment.

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Department of pediatric neurology Sharee Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of hypertonic cerebral palsy
  • ages 3-12 years

Exclusion Criteria:

  • refusal to put on headphones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Adi Aran, DR, Sharee Zedek Medical Center , Jerusallem , Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2006

Last Update Submitted That Met QC Criteria

October 31, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30/10/2006.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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