Impact of Listening to Low Tones on Motor Function in Children With CP
NCT ID: NCT00394641
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Interventions
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listening to music / stories via stereophonic headphones
Eligibility Criteria
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Inclusion Criteria
* ages 3-12 years
Exclusion Criteria
3 Years
12 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Principal Investigators
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Adi Aran, DR
Role: PRINCIPAL_INVESTIGATOR
Sharee Zedek Medical Center , Jerusallem , Israel
Locations
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Department of pediatric neurology Sharee Zedek Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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30/10/2006.CTIL
Identifier Type: -
Identifier Source: org_study_id
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