Cerebral PalsyNCT00394641
Impact of Listening to Low Tones on Motor Function in Children With CP
A study testing listening to music / stories via stereophonic headphones in people with Cerebral Palsy and Hypertonia, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Palsy, Hypertonia
- What is being tested?
- listening to music / stories via stereophonic headphones
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of hypertonic cerebral palsy
- ages 3-12 years
Who cannot join
- refusal to put on headphones
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of pediatric neurology Sharee Zedek Medical Center
Jerusalem
About this 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
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.
Read more
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.
Read the 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:
- Neurological evaluation with their medical charts.
- Physiotherapic evaluation using the GMFM assessment and a surface EMG
- Fine motor assessment using the QUEST and visual assessments.
- 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
- Cerebral Palsy, Hypertonia
- Being tested
- listening to music / stories via stereophonic headphones
- Medical subject headings
- Cerebral Palsy, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
listening to music / stories via stereophonic headphonesBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Adi Aran, DR, Principal investigator, Sharee Zedek Medical Center , Jerusallem , Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394641
- Sponsor's protocol ID
- 30/10/2006.CTIL
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2006
- Last updated
- 13 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Listening to Low Tones Via Sterephonic Headphones on Hypertonia and Motor Function in Children With Cerebral Palsy- Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00394641
- Acronym / sponsor ID
- 30/10/2006.CTIL
- Conditions
- Cerebral Palsy, Hypertonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- First posted
- 1 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Neurological evaluation with their medical charts.
- Physiotherapic evaluation using the GMFM assessment and a surface EMG
- Fine motor assessment using the QUEST and visual assessments.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of hypertonic cerebral palsy
- ages 3-12 years
Key exclusion criteria (1 listed)
- refusal to put on headphones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| listening to music / stories via stereophonic headphones | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adi Aran, DR principal investigator
Sharee Zedek Medical Center , Jerusallem , Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing listening to music / stories via stereophonic headphones in people with Cerebral Palsy and Hypertonia, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.