Pediatric Neural Sleeve Validation

NCT05660096 | Withdrawn DMC FDA Device

• 1 other identifier: IRB#22-000971
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  1 to 2 hours for follow-up clinical visit

Study Arms (2)

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.

Device: Cionic Neural Sleeve NS-100

Interventions

Cionic Neural Sleeve NS-100 DEVICE

Sleeve applies neuromuscular stimulation as patients walk to help contract appropriate muscles at appropriate times.

Also known as: External functional neuromuscular stimulator

Patient with Cerebral Palsy, with sleeve

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Cionic, Inc.: collaborator

Study Sites (1)

University of California - Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rachel Thompson

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: William and Patricia Oppenheim Presidential Chair in Pediatric Orthopaedics and Assistant Professor-in-Residence, UCLA Department of Orthopaedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)