Precision Gait Retraining for Children With Cerebral Palsy

NCT ID: NCT04717323

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2021-01-31

Brief Summary

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

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.

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients

Gait with and without pelvic assistance

Group Type: EXPERIMENTAL

mPAD (or TPAD) Pelvic Assist Device

Intervention Type: DEVICE

Gait retraining device that applies pelvic forces and measures response

No Intervention

Intervention Type: DEVICE

Gait with no pelvic assistance

Controls

Gait with no pelvic assistance

Group Type: EXPERIMENTAL

No Intervention

Intervention Type: DEVICE

Gait with no pelvic assistance

Interventions

mPAD (or TPAD) Pelvic Assist Device

Gait retraining device that applies pelvic forces and measures response

Intervention Type: DEVICE

No Intervention

Gait with no pelvic assistance

Intervention Type: DEVICE

Other Intervention Names

mPAD (or TPAD)

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Altec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Contessa, PhD

Role: PRINCIPAL_INVESTIGATOR

Altec Inc.

Locations

Altec Inc.

Natick, Massachusetts, United States

CUMC Harkness Pavillion

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

mPAD Phase 1

Identifier Type: -

Identifier Source: org_study_id