Hemiplegic Cerebral PalsyNCT01817179
Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
A study testing FES neuroprosthesis to dorsiflexors on affected leg in people with Hemiplegic Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- FES neuroprosthesis to dorsiflexors on affected leg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2014
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of hemiplegic Cerebral Palsy
- Gross Motor Function Classification System (GMFCS) I or II
- Age 6-17 years inclusive
- Demonstrate foot drop during gait without wearing ankle foot orthosis
- Tolerance to neuroprosthesis stimulation
- Physician referral to participate in intervention
Show all 10Show fewer
- Passive dorsiflexion to at least neutral with knee extended
- Available to travel to and from study visits
- Ability to follow instructions and cooperate with study protocol
- Caregiver reads and understands English
Who cannot join
- Any metal implants containing electrical circuitry
- Continuous regular use of neuroprosthesis stimulation previous to study enrollment
- Previous orthopaedic procedure involving tibialis anterior muscle at any time
- Previous orthopaedic procedure to affected limb in the last year
- Botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study
- Any condition that PI feels would limit ambulatory progress (e.g. arthritis, uncontrolled seizures)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy
The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities.
The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- FES neuroprosthesis to dorsiflexors on affected leg
- Keywords
- hemiplegia, cerebral palsy, neuroprosthesis, children
- Medical subject headings
- Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES neuroprosthesis to dorsiflexors on affected legOther
Also called Bioness L300
| Study group | Role | What they receive |
|---|---|---|
| FES neuroprosthesis to dorsiflexors on affected side | Experimental | Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home. Receives: Other: FES neuroprosthesis to dorsiflexors on affected leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak ankle dorsiflexion range during swing phase in gait
Measured: will be assessed at baseline and 3 months after continous use of neuroprosthesis
Secondary outcomes (1)
gait efficiency
Measured: after 3 months of neuroprosthesis use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy F Bailes, PT, MS, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817179
- Sponsor's protocol ID
- CIN001-Effects of FES/PwP
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01817179
- Acronym / sponsor ID
- CIN001-Effects of FES/PwP
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- hemiplegia, cerebral palsy, neuroprosthesis, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Mar 2013 (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 purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities.
The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES neuroprosthesis to dorsiflexors on affected side | Experimental | Other: FES neuroprosthesis to dorsiflexors on affected legParticipants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Diagnosis of hemiplegic Cerebral Palsy
- Gross Motor Function Classification System (GMFCS) I or II
- Age 6-17 years inclusive
- Demonstrate foot drop during gait without wearing ankle foot orthosis
- Tolerance to neuroprosthesis stimulation
Key exclusion criteria (6 listed)
- Any metal implants containing electrical circuitry
- Continuous regular use of neuroprosthesis stimulation previous to study enrollment
- Previous orthopaedic procedure involving tibialis anterior muscle at any time
- Previous orthopaedic procedure to affected limb in the last year
- Botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study
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 |
|---|---|---|
| FES neuroprosthesis to dorsiflexors on affected legAlso: Bioness L300 | Other | FES neuroprosthesis to dorsiflexors on affected side |
Primary outcome
peak ankle dorsiflexion range during swing phase in gait
Time frame: will be assessed at baseline and 3 months after continous use of neuroprosthesis
1 secondary outcome
gait efficiency
Time frame: after 3 months of neuroprosthesis use
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 28 Jan 2015.
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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.
Amy F Bailes, PT, MS principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES neuroprosthesis to dorsiflexors on affected leg in people with Hemiplegic Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati 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 10 inclusion and 6 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 28 Jan 2015. 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.
What does the primary outcome measure?
peak ankle dorsiflexion range during swing phase in gait (time frame: will be assessed at baseline and 3 months after continous use of neuroprosthesis). It is what the study was designed to measure, not a finding.
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 28 Jan 2015.