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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00394641
First received: October 31, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

October 31, 2006
October 31, 2006
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Impact of Listening to Low Tones on Motor Function in Children With CP
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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
  • Cerebral Palsy
  • Hypertonia
Behavioral: listening to music / stories via stereophonic headphones
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
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Inclusion Criteria:

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

Exclusion Criteria:

  • refusal to put on headphones
Both
3 Years to 12 Years
No
Contact: Adi Aran 97226416162 adi.efrat.aran@gmail.com
Israel
 
NCT00394641
30/10/2006.CTIL
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Shaare Zedek Medical Center
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Principal Investigator: Adi Aran, DR Sharee Zedek Medical Center , Jerusallem , Israel
Shaare Zedek Medical Center
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP