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Pediatric Neural Sleeve Validation

Studies

Study First Submitted Date 2022-11-28
Study First Posted Date 2022-12-21
Last Update Posted Date 2023-06-13
Start Month Year January 2024
Primary Completion Month Year December 2026
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-13

Detailed Descriptions

Sequence: 20547211
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.

Facilities

Sequence: 198389182
Name University of California – Los Angeles
City Los Angeles
State California
Zip 90095
Country United States

Conditions

Sequence: 51723215
Name Cerebral Palsy
Downcase Name cerebral palsy

Id Information

Sequence: 39802589
Id Source org_study_id
Id Value IRB#22-000971

Countries

Sequence: 42201370
Name United States
Removed False

Design Groups

Sequence: 55142819 Sequence: 55142820
Group Type No Intervention Group Type Active Comparator
Title Patient with Cerebral Palsy, no intervention Title Patient with Cerebral Palsy, with sleeve
Description Gait analysis of cerebral palsy patients without any intervention. Description Gait analysis of cerebral palsy patients while wearing neural sleeve.

Interventions

Sequence: 52044744
Intervention Type Device
Name Cionic Neural Sleeve NS-100
Description Sleeve applies neuromuscular stimulation as patients walk to help contract appropriate muscles at appropriate times.

Design Outcomes

Sequence: 175919170 Sequence: 175919171 Sequence: 175919172
Outcome Type primary Outcome Type primary Outcome Type secondary
Measure Range of motion (degrees) in lower extremities Measure Neuromodulation activity (motor unit potential) Measure Patient-reported physical function (PROMIS score)
Time Frame 2 to 4 hours for formal gait analysis visit Time Frame 2 to 4 hours for formal gait analysis visit, data collection continuously for 12 weeks after study visit Time Frame 1 to 2 hours for follow-up clinical visit
Description 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. Description 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. Description 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.

Browse Conditions

Sequence: 191685205 Sequence: 191685206 Sequence: 191685207 Sequence: 191685208 Sequence: 191685209
Mesh Term Cerebral Palsy Mesh Term Brain Damage, Chronic Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases
Downcase Mesh Term cerebral palsy Downcase Mesh Term brain damage, chronic Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47903560 Sequence: 47903561
Agency Class OTHER Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of California, Los Angeles Name Cionic, Inc.

Overall Officials

Sequence: 29024814
Role Principal Investigator
Name Rachel Thompson
Affiliation University of California, Los Angeles

Central Contacts

Sequence: 11918167 Sequence: 11918168
Contact Type primary Contact Type backup
Name Jennifer Kallini Name Christina Sun
Phone 3109401353 Phone 2137421057
Email jrkallini@mednet.ucla.edu Email cksun@mednet.ucla.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 67602215
Design Group Id 55142820
Intervention Id 52044744

Eligibilities

Sequence: 30504366
Gender All
Minimum Age 8 Years
Maximum Age 14 Years
Healthy Volunteers No
Criteria Inclusion Criteria: 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 Exclusion Criteria: 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
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254049416
Number Of Facilities 1
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 8
Maximum Age Num 14
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30253454
Allocation Non-Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention 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.

Intervention Other Names

Sequence: 26453820
Intervention Id 52044744
Name External functional neuromuscular stimulator

Responsible Parties

Sequence: 28633937
Responsible Party Type Principal Investigator
Name Rachel Thompson, MD
Title William and Patricia Oppenheim Presidential Chair in Pediatric Orthopaedics and Assistant Professor-in-Residence, UCLA Department of Orthopaedic Surgery
Affiliation University of California, Los Angeles