Cerebral PalsyNCT05660096
Pediatric Neural Sleeve Validation
A study testing Cionic Neural Sleeve NS-100 in people with Cerebral Palsy, run by University of California, Los Angeles at 1 site in United States.
Trial summary
In individuals with cerebral palsy (CP), signals from the brain to the muscles that are required for coordinated walking are either poorly controlled or absent. This results in abnormal walking (or gait) patterns and difficulty with independent movement. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Cionic Neural Sleeve NS-100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2024to Dec 2026
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-14 years
- Diagnosis of spastic cerebral palsy affecting one or both legs
- Able to independently sit, stand and walk with or without assistive device or bracing
- Able to walk at least 50 feet with or without assistive device or bracing
- Able to understand and follow basic instructions in English
- A Parent/Guardian must accompany and be present with the child participant
Who cannot join
- Cognitive impairment that would preclude participation
- Lower motor neuron disease or injury that may impair response to stimulation
- Diagnosis of any neurologic disease aside from spastic cerebral palsy
- Dyskinetic movement disorder
- Have skin conditions of the affected lower limb, including cuts, burns or lesions that would preclude placement of electrodes
- Have a latex allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California - Los Angeles
Los Angeles, California, 90095
About this study
Official title: Validation of Cionic Neural Sleeve for Use in Pediatric Patients With Cerebral Palsy
In individuals with cerebral palsy (CP), signals from the brain to the muscles that are required for coordinated walking are either poorly controlled or absent. This results in abnormal walking (or gait) patterns and difficulty with independent movement. The purposes of this study is to test a device - a wearable leg sleeve - that can measure the abnormal signals sent from the brain to the muscles and the resulting movements and then send signals to the muscles to help make walking easier and smoother.
20 participants with, and 10 participants without, CP are being asked to come to test the device at the Kameron Gait and Motion Analysis Center. This requires one visit, which will last approximately 2-4 hours. During this visit, participants will undergo a physical exam and will be fit for the device on their leg. The participant will be asked to move their legs while the device is on to calibrate the device, and then the participants will walk while the device is interpreting their movement patterns. Participants with cerebral palsy will additionally walk with the device on their leg in a "corrective mode," where the device will provide stimulation to certain muscles in their leg in order to improve the patient's walking pattern.
Last, participants will complete an instrumented gait analysis. Gait analysis involves recording movement patterns during walking using small reflective markers and sensor taped to the participant's legs and trunk. A series of cameras and computers are used to record the leg position and the walking speed. This data will be compared to the data provided from the device.
Read the detailed description
This is a comparative cohort study testing the accuracy of a wearable Neural Sleeve in collecting kinematic data in children (age 8-14 years) with CP and healthy control subjects as well as the Sleeve's ability to normalize gait patterns in patients with CP. The Cionic Neural Sleeve measures information on how people move. The system consists of 4 leg straps, 2 foot sensors, and 2 foot insoles (or pressure sensors), connected by insulated wires to a battery-powered control box worn on the thigh. The Cionic sensing devices are made up of sensors that are either part of wearable garments held snugly in place with Velcro and sticky electrode gel, or attached to the shoes. This system will measure and record electromyographic data from the muscles as well as kinematic data in the lower extremities during normal walking speeds in all participants.
All subjects will be examined by a licensed physician or physical therapist prior to fitting the Neural Sleeve. This will consist of lower extremity range of motion, strength testing and selective motor control (all components are part of a typical pediatric orthopaedic neuromuscular physical exam). Thereafter, each participant will be fit for the components of the Cionic Neural Sleeve. Two stretchy leg straps containing multiple sensors will be secured to each leg with Velcro. One strap will be secured around each thigh and one around each shank (lower leg). These straps will measure two things: (1) the activity levels of the muscles underneath the straps, and (2) the physical orientation of the legs. One additional foot sensor will also be attached to the top of each shoe to measure the physical orientation of the subjects feet. The straps and foot sensors will be connected by stretchable wires. Last, thin pressure-sensing pressure pads will be inserted inside each shoe underneath your regular shoe insoles (which will be temporarily removed). The pressure sensors measure where the foot is applying downward pressure inside the shoes at all times. All wires/outputs from sensors will be connected to a battery-powered control box worn at the hip, capable of stimulating muscle contractions (manually or algorithmically). These devices connect wirelessly via Bluetooth to an application running on a smartphone utilized only in the laboratory. The smartphone's camera will record video of the lower body. We will not record the face.
The sleeve will be calibrated through completing a series of tasks while wearing the sleeve for up to 5 minutes, including dorsiflexion/plantarflexion, knee extension and knee flexion. Thereafter, subjects will be asked to then walk at their preferred speed for 2 minutes while the Neural Sleeve collects data only.
Next, all patients will complete a limited instrumented gait analysis. Gait analysis involves recording movement patterns during walking using small reflective markers and sensor taped to the limbs of the subjects. A series of cameras and computers are used to record the kinematic output and temporospatial parameters (speed, cadence, stride width, stride length). Kinematic data from the instrumented gait analysis will be compared to kinematic data collected from the Cionic Neural Sleeve.
Last, in the CP cohort, subjects will be fit with a Functional Electrical Stimulation (FES) control box clipped to the hip or thigh and a maximum of eight pairs (16 total) of sticky electrode pads worn on the shins, calves, quadriceps, and/or hamstrings. These electrodes will connect to the FES control box via insulated wires. FES will then be calibrated to the subject. While seated or lying down, subjects will move their legs and experience targeted FES. FES applies small electrical charges to stimulate the muscle to perform the usual movement, similar to an over-the-counter TENs unit.This will be repeated on each of the 4 main muscle groups: quadriceps, hamstrings, calf, and tibialis anterior (front of lower leg). Each stimulation will last approximately 1 minute long and there will be as much time for rest between stimulations as needed.
CP subjects will then be asked to walk at their preferred speed for up to 2 minutes while the previously-collected EMG data will be used to inform the FES assistance. Kinematic data from collected from the Cionic Neural Sleeve on recording mode only will be compared to FES-assisted kinematic data from the sleeve and from formal gait analysis. They will be sent home with the sleeve to allow for a continuation of the aforementioned analyses over a 12-week period. PROMIS scores will then be collected.
---
sleeve settings: Frequency: 5 Hz to 125 0Hz (5 Hz increments) Pulse width: 100 µs to 400µs (100 µs increments) Intensity: 0 mA to 100 mA (5 mA increments)
A member of the Cionic team will facilitate the configuration and protocol/parameters for the first 2-3 patients while concurrently training members of the study staff. The trained staff member(s) will then take over with device configuration for subsequent patients.
- Conditions
- Cerebral Palsy
- Being tested
- Cionic Neural Sleeve NS-100
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cionic Neural Sleeve NS-100Device
Also called External functional neuromuscular stimulator
Sleeve applies neuromuscular stimulation as patients walk to help contract appropriate muscles at appropriate times.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Cerebral Palsy, no intervention | No intervention | Gait analysis of cerebral palsy patients without any intervention. |
| Patient with Cerebral Palsy, with sleeve | Active comparator | Gait analysis of cerebral palsy patients while wearing neural sleeve. Receives: Device: Cionic Neural Sleeve NS-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (degrees) in lower extremities
Participants will be evaluated on range of motion in degrees by performing dorsiflexion, plantarflexion, knee extension, and knee flexion exercises. The physical orientation of both legs and feet, selective motor control, and lower extremity strength will also be evaluated while participants walk for up to two minutes. Specific measures include ambulation speed (km per hour), walking cadence (steps per minute), stride width (inches), and stride length (inches).
Baseline measures will be obtained in a standard neuromuscular physical exam performed by a licensed physician or physical therapist. During the intervention phase of the study, these measures will be obtained in a formal limited instrument gait analysis while wearing a neural sleeve. Movement patterns will be captured using small reflective markers and sensors to record kinematic output.
Measured: 2 to 4 hours for formal gait analysis visit
Neuromodulation activity (motor unit potential)
Kinematic data from the instrumented gait analysis will be compared to kinematic data collected from the Cionic Neural Sleeve. Specifically, electrical activity, measured by motor unit potential (E-MUP) waveforms and their magnitudes, obtained via electromyography during the gait analysis will be compared to the electrical activity obtained from neuromodulation via the neural sleeve. Neuromodulation will be assessed on the four main muscle groups: quadriceps, hamstrings, calf, and tibialis anterior.
Measured: 2 to 4 hours for formal gait analysis visit, data collection continuously for 12 weeks after study visit
Secondary outcomes (1)
Patient-reported physical function (PROMIS score)
Patient-Reported Outcomes Measurement Information System (PROMIS) scores will be collected from cerebral palsy patients at the conclusion of the 12-week neural sleeve data collection period. The PROMIS questionnaire will generate patient-reported scores to measure physical function.
Measured: 1 to 2 hours for follow-up clinical visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study startJan 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: unable to obtain neural sleeve through partner company
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 California, Los AngelesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Cerebral palsy patients will undergo gait analysis without the sleeve in the first phase of the study. The same patients will then under gait analysis with the sleeve in the second phase of the study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Cionic, Inc.
- Responsible party
- Principal investigator, Rachel Thompson, MD, University of California, Los Angeles
- Investigators
- Rachel Thompson, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660096
- Sponsor's protocol ID
- IRB#22-000971
- Status last verified
- Jul 2024
- First submitted
- 28 Nov 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data and gait analytics of individual participants with other researchers will not be shared at this time. De-identified IPD may be shared in the future.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cionic Neural Sleeve for Use in Pediatric Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05660096
- Acronym / sponsor ID
- IRB#22-000971
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to obtain neural sleeve through partner company
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Cionic, Inc.
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Dec 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.
In individuals with cerebral palsy (CP), signals from the brain to the muscles that are required for coordinated walking are either poorly controlled or absent. This results in abnormal walking (or gait) patterns and difficulty with independent movement. The purposes of this study is to test a device - a wearable leg sleeve - that can measure the abnormal signals sent from the brain to the muscles and the resulting movements and then send signals to the muscles to help make walking easier and smoother.
20 participants with, and 10 participants without, CP are being asked to come to test the device at the Kameron Gait and Motion Analysis Center. This requires one visit, which will last approximately 2-4 hours. During this visit, participants will undergo a physical exam and will be fit for the device on their leg. The participant will be asked to move their legs while the device is on to calibrate the device, and then the participants will walk while the device is interpreting their movement patterns. Participants with cerebral palsy will additionally walk with the device on their leg in a "corrective mode," where the device will provide stimulation to certain muscles in their leg in order to improve the patient's walking pattern.
Last, participants will complete an instrumented gait analysis. Gait analysis involves recording movement patterns during walking using small reflective markers and sensor taped to the participant's legs and trunk. A series of cameras and computers are used to record the leg position and the walking speed. This data will be compared to the data provided from the device.
Detailed description
This is a comparative cohort study testing the accuracy of a wearable Neural Sleeve in collecting kinematic data in children (age 8-14 years) with CP and healthy control subjects as well as the Sleeve's ability to normalize gait patterns in patients with CP. The Cionic Neural Sleeve measures information on how people move. The system consists of 4 leg straps, 2 foot sensors, and 2 foot insoles (or pressure sensors), connected by insulated wires to a battery-powered control box worn on the thigh. The Cionic sensing devices are made up of sensors that are either part of wearable garments held snugly in place with Velcro and sticky electrode gel, or attached to the shoes. This system will measure and record electromyographic data from the muscles as well as kinematic data in the lower extremities during normal walking speeds in all participants.
All subjects will be examined by a licensed physician or physical therapist prior to fitting the Neural Sleeve. This will consist of lower extremity range of motion, strength testing and selective motor control (all components are part of a typical pediatric orthopaedic neuromuscular physical exam). Thereafter, each participant will be fit for the components of the Cionic Neural Sleeve. Two stretchy leg straps containing multiple sensors will be secured to each leg with Velcro. One strap will be secured around each thigh and one around each shank (lower leg). These straps will measure two things: (1) the activity levels of the muscles underneath the straps, and (2) the physical orientation of the legs. One additional foot sensor will also be attached to the top of each shoe to measure the physical orientation of the subjects feet. The straps and foot sensors will be connected by stretchable wires. Last, thin pressure-sensing pressure pads will be inserted inside each shoe underneath your regular shoe insoles (which will be temporarily removed). The pressure sensors measure where the foot is applying downward pressure inside the shoes at all times. All wires/outputs from sensors will be connected to a battery-powered control box worn at the hip, capable of stimulating muscle contractions (manually or algorithmically). These devices connect wirelessly via Bluetooth to an application running on a smartphone utilized only in the laboratory. The smartphone's camera will record video of the lower body. We will not record the face.
The sleeve will be calibrated through completing a series of tasks while wearing the sleeve for up to 5 minutes, including dorsiflexion/plantarflexion, knee extension and knee flexion. Thereafter, subjects will be asked to then walk at their preferred speed for 2 minutes while the Neural Sleeve collects data only.
Next, all patients will complete a limited instrumented gait analysis. Gait analysis involves recording movement patterns during walking using small reflective markers and sensor taped to the limbs of the subjects. A series of cameras and computers are used to record the kinematic output and temporospatial parameters (speed, cadence, stride width, stride length). Kinematic data from the instrumented gait analysis will be compared to kinematic data collected from the Cionic Neural Sleeve.
Last, in the CP cohort, subjects will be fit with a Functional Electrical Stimulation (FES) control box clipped to the hip or thigh and a maximum of eight pairs (16 total) of sticky electrode pads worn on the shins, calves, quadriceps, and/or hamstrings. These electrodes will connect to the FES control box via insulated wires. FES will then be calibrated to the subject. While seated or lying down, subjects will move their legs and experience targeted FES. FES applies small electrical charges to stimulate the muscle to perform the usual movement, similar to an over-the-counter TENs unit.This will be repeated on each of the 4 main muscle groups: quadriceps, hamstrings, calf, and tibialis anterior (front of lower leg). Each stimulation will last approximately 1 minute long and there will be as much time for rest between stimulations as needed.
CP subjects will then be asked to walk at their preferred speed for up to 2 minutes while the previously-collected EMG data will be used to inform the FES assistance. Kinematic data from collected from the Cionic Neural Sleeve on recording mode only will be compared to FES-assisted kinematic data from the sleeve and from formal gait analysis. They will be sent home with the sleeve to allow for a continuation of the aforementioned analyses over a 12-week period. PROMIS scores will then be collected.
---
sleeve settings: Frequency: 5 Hz to 125 0Hz (5 Hz increments) Pulse width: 100 µs to 400µs (100 µs increments) Intensity: 0 mA to 100 mA (5 mA increments)
A member of the Cionic team will facilitate the configuration and protocol/parameters for the first 2-3 patients while concurrently training members of the study staff. The trained staff member(s) will then take over with device configuration for subsequent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cerebral palsy patients will undergo gait analysis without the sleeve in the first phase of the study. The same patients will then under gait analysis with the sleeve in the second phase of the study.
| Arm | Type | Receives |
|---|---|---|
| Patient with Cerebral Palsy, no intervention | No intervention | –Gait analysis of cerebral palsy patients without any intervention. |
| Patient with Cerebral Palsy, with sleeve | Active comparator | Device: Cionic Neural Sleeve NS-100Gait analysis of cerebral palsy patients while wearing neural sleeve. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 8-14 years
- Diagnosis of spastic cerebral palsy affecting one or both legs
- Able to independently sit, stand and walk with or without assistive device or bracing
- Able to walk at least 50 feet with or without assistive device or bracing
- Able to understand and follow basic instructions in English
Key exclusion criteria (6 listed)
- Cognitive impairment that would preclude participation
- Lower motor neuron disease or injury that may impair response to stimulation
- Diagnosis of any neurologic disease aside from spastic cerebral palsy
- Dyskinetic movement disorder
- Have skin conditions of the affected lower limb, including cuts, burns or lesions that would preclude placement of electrodes
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 |
|---|---|---|
| Cionic Neural Sleeve NS-100Also: External functional neuromuscular stimulatorSleeve applies neuromuscular stimulation as patients walk to help contract appropriate muscles at appropriate times. | Device | Patient with Cerebral Palsy, with sleeve |
Primary outcome
Range of motion (degrees) in lower extremities
Time frame: 2 to 4 hours for formal gait analysis visit
Participants will be evaluated on range of motion in degrees by performing dorsiflexion, plantarflexion, knee extension, and knee flexion exercises. The physical orientation of both legs and feet, selective motor control, and lower extremity strength will also be evaluated while participants walk for up to two minutes. Specific measures include ambulation speed (km per hour), walking cadence (steps per minute), stride width (inches), and stride length (inches). Baseline measures will be obtained in a standard neuromuscular physical exam performed by a licensed physician or physical therapist. During the intervention phase of the study, these measures will be obtained in a formal limited instrument gait analysis while wearing a neural sleeve. Movement patterns will be captured using small reflective markers and sensors to record kinematic output.
Neuromodulation activity (motor unit potential)
Time frame: 2 to 4 hours for formal gait analysis visit, data collection continuously for 12 weeks after study visit
Kinematic data from the instrumented gait analysis will be compared to kinematic data collected from the Cionic Neural Sleeve. Specifically, electrical activity, measured by motor unit potential (E-MUP) waveforms and their magnitudes, obtained via electromyography during the gait analysis will be compared to the electrical activity obtained from neuromodulation via the neural sleeve. Neuromodulation will be assessed on the four main muscle groups: quadriceps, hamstrings, calf, and tibialis anterior.
1 secondary outcome
Patient-reported physical function (PROMIS score)
Time frame: 1 to 2 hours for follow-up clinical visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No. De-identified data and gait analytics of individual participants with other researchers will not be shared at this time. De-identified IPD may be shared in the future.
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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.
Rachel Thompson principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cionic Neural Sleeve NS-100 in people with Cerebral Palsy, run by University of California, Los Angeles 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 6 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: withdrawn, as of the sponsor's last update on 25 Jul 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Range of motion (degrees) in lower extremities (time frame: 2 to 4 hours for formal gait analysis visit). The study lists 2 primary outcomes in all. 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 25 Jul 2024.