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| Sponsored by: |
Shaare Zedek Medical Center |
| Information provided by: | Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT00394641 |
Purpose
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.
| Condition | Intervention |
|
Cerebral Palsy Hypertonia |
Behavioral: listening to music / stories via stereophonic headphones |
| MedlinePlus related topics: | Cerebral Palsy Paralysis |
| Study Type: | Interventional |
| Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Impact of Listening to Low Tones Via Sterephonic Headphones on Hypertonia and Motor Function in Children With Cerebral Palsy- Randomized Controlled Study |
| Estimated Enrollment: | 30 |
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:
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.
Eligibility
| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Adi Aran | 97226416162 | adi.efrat.aran@gmail.com |
| Israel | |||||
| Department of pediatric neurology Sharee Zedek Medical Center | Not yet recruiting | ||||
| Jerusalem, Israel | |||||
| Principal Investigator: Adi Aran | |||||
| Shaare Zedek Medical Center |
| Principal Investigator: | Adi Aran, DR | Sharee Zedek Medical Center , Jerusallem , Israel |
More Information
| Study ID Numbers: | 30/10/2006.CTIL |
| First Received: | October 31, 2006 |
| Last Updated: | October 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00394641 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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