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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Impact of Listening to Low Tones Via Sterephonic Headphones on Hypertonia and Motor Function in Children With Cerebral Palsy- Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Estimated Enrollment: 30
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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal to put on headphones
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394641

Contacts
Contact: Adi Aran 97226416162 adi.efrat.aran@gmail.com

Locations
Israel
Department of pediatric neurology Sharee Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Principal Investigator: Adi Aran         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Adi Aran, DR Sharee Zedek Medical Center , Jerusallem , Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00394641     History of Changes
Other Study ID Numbers: 30/10/2006.CTIL
Study First Received: October 31, 2006
Last Updated: October 31, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Hypertonia
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 28, 2014