Cerebral PalsyNCT05233748
Neuromotor Control During Walking in Children With Cerebral Palsy
A study testing Stochastic Resonance (SR) in people with Cerebral Palsy, run by University of Delaware at 1 site in United States.
Trial summary
One out of every three children with cerebral palsy (CP) falls daily, with more than half of the falls occurring while walking. To avoid falling, the nervous system must continuously monitor how the body moves and, when an imbalance is detected, activate muscles for an appropriate correction. Read more about this study
- Who is it for?
- Ages 8 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Stochastic Resonance (SR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 28 Sep 2022
- 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 8 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 8 - 24 years
- Diagnosis of spastic diplegic or hemiplegic CP (for participants with CP group only)
- GMFCS classification level I or II (ability to walk independently with using any assistive device)
- Visual, perceptual, and cognitive/ communication skills to follow multiple step commands
- Seizure-free or well controlled seizures
- Ability to communicate pain or discomfort during testing procedures
- Parental/guardian consent and child assent/consent
Who cannot join
- Diagnosis of athetoid, ataxic or quadriplegic CP
- Significant scoliosis (scoliometer angle > 9°)
- History of selective dorsal root rhizotomy
- Botox injections in the lower limb within the past 6 months
- Severe spasticity of the lower extremity muscles (e.g. a score of 4 on the Modified Ashworth Scale)
- Severely limited range of motion/ irreversible muscle contractures
Show all 9Show fewer
- Lower extremity surgery or fractures in the year prior testing
- Joint instability or dislocation in the lower extremities
- Marked visual or hearing deficits
Trial locations and contacts
1 site in 1 country.
About this study
One out of every three children with cerebral palsy (CP) falls daily, with more than half of the falls occurring while walking. To avoid falling, the nervous system must continuously monitor how the body moves and, when an imbalance is detected, activate muscles for an appropriate correction. In this project, we will use small electrical stimulation of muscles and tendons that enhances the sense of body positioning, to allow children with CP to generate more accurate balance corrections.
- Conditions
- Cerebral Palsy
- Being tested
- Stochastic Resonance (SR)
- Keywords
- locomotor control, balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic Resonance (SR)Device
The system consists of six linear isolated stimulators (STMISOLA, Biopac Systems, Inc., Goleta, USA). The SR signal (Gaussian White Noise, zero mean) will be generated through a 16 bit PCI 6733 National Instruments multifunction data acquisition card by a custom LabView program. The stimulation sites include the ankle, lateral soleus, peroneus longus, and tibialis anterior muscles and the hip.
| Study group | Role | What they receive |
|---|---|---|
| Stochastic Resonance (SR) | Experimental | During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations. Receives: Device: Stochastic Resonance (SR) |
| No Stochastic Resonance (noSR) | No intervention | During this condition, participants will walk on the treadmill while receiving no SR stimulation (noSR) with and without visual perturbations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Margin of Stability(MOS)
MOS refers to the distance between extrapolated center of mass (which includes center of mass position and velocity) and the base of support. It has been previously used to measure balance in children with cerebral palsy, patients with stroke, Parkinson Disease, and Multiple Sclerosis. We will measure center of mass using kinetics and kinematic computed through a motion capture system(Qualysis).
For the visual perturbation conditions, we will use center of mass excursion as the primary outcome measure (since it has been used in prior studies in children and adults using visual perturbation protocols).
Measured: At the end of the session after 6 minutes of stimulation i.e Pre stimulation MOS - Post stimulation MOS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start30 Oct 2020
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross sectional study of responses to visual perturbations in two groups, children with CP and age-and sex- matched TD (typical development). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a control / no stochastic resonance (noSR) condition while walking with and without visual perturbations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Jeka, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233748
- Sponsor's protocol ID
- 1125634
- Status last verified
- Sep 2022
- First submitted
- 14 Oct 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromotor Control During Walking in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05233748
- Acronym / sponsor ID
- 1125634
- Conditions
- Cerebral Palsy
- Keywords
- locomotor control, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- 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.
One out of every three children with cerebral palsy (CP) falls daily, with more than half of the falls occurring while walking. To avoid falling, the nervous system must continuously monitor how the body moves and, when an imbalance is detected, activate muscles for an appropriate correction. In this project, we will use small electrical stimulation of muscles and tendons that enhances the sense of body positioning, to allow children with CP to generate more accurate balance corrections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cross sectional study of responses to visual perturbations in two groups, children with CP and age-and sex- matched TD (typical development). Each group will undergo two stimulation conditions, stochastic resonance (SR) stimulation and a control / no stochastic resonance (noSR) condition while walking with and without visual perturbations.
| Arm | Type | Receives |
|---|---|---|
| Stochastic Resonance (SR) | Experimental | Device: Stochastic Resonance (SR)During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations. |
| No Stochastic Resonance (noSR) | No intervention | –During this condition, participants will walk on the treadmill while receiving no SR stimulation (noSR) with and without visual perturbations. |
Who may qualify
- Ages
- 8 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 8 - 24 years
- Diagnosis of spastic diplegic or hemiplegic CP (for participants with CP group only)
- GMFCS classification level I or II (ability to walk independently with using any assistive device)
- Visual, perceptual, and cognitive/ communication skills to follow multiple step commands
- Seizure-free or well controlled seizures
Key exclusion criteria (9 listed)
- Diagnosis of athetoid, ataxic or quadriplegic CP
- Significant scoliosis (scoliometer angle > 9°)
- History of selective dorsal root rhizotomy
- Botox injections in the lower limb within the past 6 months
- Severe spasticity of the lower extremity muscles (e.g. a score of 4 on the Modified Ashworth Scale)
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 |
|---|---|---|
| Stochastic Resonance (SR)The system consists of six linear isolated stimulators (STMISOLA, Biopac Systems, Inc., Goleta, USA). The SR signal (Gaussian White Noise, zero mean) will be generated through a 16 bit PCI 6733 National Instruments multifunction data acquisition card by a custom LabView program. The stimulation sites include the ankle, lateral soleus, peroneus longus, and tibialis anterior muscles and the hip. | Device | Stochastic Resonance (SR) |
Primary outcome
Change in Margin of Stability(MOS)
Time frame: At the end of the session after 6 minutes of stimulation i.e Pre stimulation MOS - Post stimulation MOS.
MOS refers to the distance between extrapolated center of mass (which includes center of mass position and velocity) and the base of support. It has been previously used to measure balance in children with cerebral palsy, patients with stroke, Parkinson Disease, and Multiple Sclerosis. We will measure center of mass using kinetics and kinematic computed through a motion capture system(Qualysis). For the visual perturbation conditions, we will use center of mass excursion as the primary outcome measure (since it has been used in prior studies in children and adults using visual perturbation protocols).
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 30 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
John Jeka, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic Resonance (SR) in people with Cerebral Palsy, run by University of Delaware 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 7 inclusion and 9 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 30 Sep 2022. 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?
Change in Margin of Stability(MOS) (time frame: At the end of the session after 6 minutes of stimulation i.e Pre stimulation MOS - Post stimulation MOS.). 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 30 Sep 2022.