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

NCT00394641 | Completed

• 1 other identifier: 30/10/2006.CTIL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Hypertonia

Interventions

listening to music / stories via stereophonic headphones BEHAVIORAL

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• refusal to put on headphones

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Department of pediatric neurology Sharee Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Hypertonia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adi Aran, DR

  Sharee Zedek Medical Center , Jerusallem , Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

IL (1)