Precision Gait Retraining for Children With Cerebral Palsy

This project will develop the first sensor-based mobile Pelvic Assist Device (mPAD) that can deliver precise, adaptable, pelvic control to restore natural coordination of upper- and lower-limb movements during gait in children with Cerebral Palsy

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Gait Disorders, Neurologic
• Intervention / Treatment: Device: mPAD (or TPAD) Pelvic Assist Device; Device: No Intervention

Detailed Description

Gait impairments hinder mobility for more than 760,000 children and adults living with cerebral palsy (CP) in the US. Motor relearning is possible for these individual but typically requires numerous training sessions with a team of physical therapists and assistants to restore coupling between upper- and lower-body segments while assisting spastic uncoordinated limb movement to improve gait kinematics. This clinical trial will meet the overall objective of testing the feasibility of developing a smart-robotic exoskeleton that is effective at providing guided pelvic assistance and support while biofeedback mediated training is facilitated under the supervision of a physiotherapist. The project will test a novel tethered Pelvic Assist Device (TPAD) with integratable electromyographic (EMG) and inertial (IMU) biofeedback that is uniquely capable of delivering precise, adaptable, multi-degree-of-freedom pelvic control to promote natural intersegmental coupling, restore coordination of upper- and lower-limb movement, and improve normal gait kinematics in children with CP. Because of its proximity to the center of mass and critical role in coordinating upper- and lower-limb control, the pelvis provides an ideal access point for physiotherapists to manually improve gait. The investigators will test the hypothesis that accurate sensor-based metrics of gait can be derived from EMG and IMU wearable sensors to develop a biofeedback system for motor learning that are integratable with TPAD to develop a new mobile mPAD device that is compliant with the target population.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Altec Inc.
  • New York
    • New York, New York, United States, 10032
      • CUMC Harkness Pavillion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (children with CP):

• Children (6-18 years of age)
• Male or Female
• Confirmed diagnosis of Cerebral Palsy by a neurologist;
• CT or MRI imaging consistent with clinical presentation;
• Clinical evidence of preserved cognition as determined by the child's neurologist;
• Clinical evidence of Mild to Moderate spastic (pyramidal) diplegia as determined by the child's neurologist;
• Gross Motor Function Classification System (GMFS) GMFCS Level II ("walks with limitations. Limitations include walking long distances and balancing, but not as able as Level I to run or jump; may require use of mobility devices when first learning to walk, usually prior to age 4; and may rely on wheeled mobility equipment when outside of home for traveling long distances."
• Spasticity being controlled by pharmaceutical or surgical correction; or has Modified Ashworth scale (MAS) = 0-2 ("More marked increase in muscle tone through most of the range of motion (ROM), but affected part(s) easily moved
• Ambulatory without assistive devices (except for long distances or on uneven terrain).
• No allergies to skin tape such as Band-Aid.

Exclusion Criteria (children with CP):

• Inability to follow simple instructions in English, or through a Spanish-speaking translator;
• Medical history of other neurological conditions;
• Medical history of cardiac or respiratory complications, or disorders that would place the subject at risk for conducting the different motor activities;
• Contractures present in lower limb - evaluated based on Tardieu Scale test where joint range of motion is measured during slow velocity movements and where contracture is operationally defined as being present if the angle at the end of range is 5 -10 degrees less than full range at ankle; and 5 -20 degrees less than full range at hip and knee.
• Skin disorders that result in open lesions or hyper-sensitive/fragile skin, preventing the use of medical-grade adhesive tapes to secure the sensors to the skin;
• Unable to provide Informed Consent from subject and Assent from parent or guardian using English or Spanish-translation informed consent form.

Inclusion Criteria (healthy volunteers):

• Adults or Children (age≥6 y.o.)
• Male or Female;
• Able to walk independently and without assistive devices;
• No history of musculoskeletal or neurological disorders;
• Able to follow directions in English.

Exclusion criteria (healthy volunteers):

• Non-English speaker;
• Unable to walk independently and without assistive devices;
• Medical history of neurological or musculoskeletal conditions (arthritis, spondylosis, etc.);
• Inability to follow simple instructions;
• Unable to provide informed consent in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Gait with and without pelvic assistance	Device: mPAD (or TPAD) Pelvic Assist Device; Gait retraining device that applies pelvic forces and measures response; Other Names: mPAD (or TPAD); Device: No Intervention; Gait with no pelvic assistance
Experimental: Controls; Gait with no pelvic assistance	Device: No Intervention; Gait with no pelvic assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Metric Accuracy	Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture	1 day
Pelvis Range of Motion During Walking	Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture	1 day
Muscle Activation During Walking	Measures electromyographic (EMG) signals of trunk and lower limb muscles during gait which are necessary for designing and implementing a mobile pelvic assist device (mPAD) system with biofeedback	1 day
Rating of Perceived Difficulty	Structured interviews will be used to grade the perception of difficulty in using the technology	1 day
Trunk Range of Motion During Walking	Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture	1 day
Hip Range of Motion During Walking	Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture	1 day
Knee Range of Motion During Walking	Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture	1 day

Collaborators and Investigators

• Sponsor: Altec Inc.
• Collaborators: Columbia University
• Investigators: Principal Investigator: Paola Contessa, PhD, Altec Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Gait Disorders; CP (Cerebral Palsy); Diplegia, Spastic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Nervous System Diseases; Paralysis; Gait Disorders, Neurologic
• Other Study ID Numbers: mPAD Phase 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data access requests will be made through conferencing
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No