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| Tracking Information | |||||
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| First Received Date ICMJE | October 31, 2006 | ||||
| Last Updated Date | October 31, 2006 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Listening to Low Tones on Motor Function in Children With CP | ||||
| Official Title ICMJE | Impact of Listening to Low Tones Via Sterephonic Headphones on Hypertonia and Motor Function in Children With Cerebral Palsy- Randomized Controlled Study | ||||
| Brief 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. |
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| 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:
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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: listening to music / stories via stereophonic headphones | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00394641 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 30/10/2006.CTIL | ||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Shaare Zedek Medical Center | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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