Cerebral PalsyNCT00473161
Use of Surface Electromyography Biofeedback to Improve Reaching in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Weakness, run by University of Southern California at 1 site in United States.
Trial summary
A newly-developed device for biofeedback of surface EMG will be used to either increase or decrease activity in the muscles of children with poor reaching due to cerebral palsy. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Cerebral Palsy, Weakness, Hypertonia
- What is being tested?
- surface EMG biofeedback
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2009
- Phase
- Observational
- 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 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with movement disorders, cerebral palsy.
Who may be able to join
- weakness, hypertonia, or hyperkinetic disorder affecting one or both arms
- reduced speed or quality of reaching
Who cannot join
- any condition that would increase the risk of participation
Trial locations and contacts
1 site in 1 country.
About this study
A newly-developed device for biofeedback of surface EMG will be used to either increase or decrease activity in the muscles of children with poor reaching due to cerebral palsy.
Read the detailed description
Children ages newborn to 21 with a diagnosis of arm weakness, hypertonia, or hyperkinesia due to cerebral palsy will be recruited. A muscle that is either over-active or under-active will be selected for each child. The child will be provided with the device to wear for 1 month in order to call attention to the identified muscle. At the beginning and end of the month, reaching will be assessed using three-dimensional kinematic motion capture. The outcome measure will be the speed and curvature of reaching to a target in front of the child.
- Conditions
- Cerebral Palsy, Weakness, Hypertonia
- Being tested
- surface EMG biofeedback
- Keywords
- movement disorders, childhood
- Medical subject headings
- Cerebral Palsy, Asthenia, Muscle Hypertonia, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface EMG biofeedbackDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2009
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.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terence Sanger, University of Southern California
- Investigators
- Terence D Sanger, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473161
- Sponsor's protocol ID
- EMG biofeedback
- Status last verified
- May 2014
- First submitted
- 11 May 2007
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Surface Electromyography Biofeedback to Improve Reaching in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00473161
- Acronym / sponsor ID
- EMG biofeedback
- Conditions
- Cerebral Palsy, Weakness, Hypertonia
- Keywords
- movement disorders, childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2009 (actual)
- First posted
- 14 May 2007 (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.
A newly-developed device for biofeedback of surface EMG will be used to either increase or decrease activity in the muscles of children with poor reaching due to cerebral palsy.
Detailed description
Children ages newborn to 21 with a diagnosis of arm weakness, hypertonia, or hyperkinesia due to cerebral palsy will be recruited. A muscle that is either over-active or under-active will be selected for each child. The child will be provided with the device to wear for 1 month in order to call attention to the identified muscle. At the beginning and end of the month, reaching will be assessed using three-dimensional kinematic motion capture. The outcome measure will be the speed and curvature of reaching to a target in front of the child.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with movement disorders, cerebral palsy.
Key inclusion criteria (2 listed)
- weakness, hypertonia, or hyperkinetic disorder affecting one or both arms
- reduced speed or quality of reaching
Key exclusion criteria (1 listed)
- any condition that would increase the risk of participation
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 |
|---|---|---|
| surface EMG biofeedback | Device | – |
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 23 May 2014.
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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.
Terence D Sanger, MD PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Weakness, run by University of Southern California at 1 site in United States.
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 23 May 2014. 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 United States. 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 23 May 2014.