Precision Gait Retraining for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Precision Gait Retraining for Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04717323
• Other study ID #: mPAD Phase 1
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2022
• Source: Altec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders, Neurologic
• Nervous System Diseases
• Paralysis

Intervention

Device:
• mPAD (or TPAD) Pelvic Assist Device
Gait retraining device that applies pelvic forces and measures response
• No Intervention
Gait with no pelvic assistance

Locations

Country	Name	City	State
United States	Altec Inc.	Natick	Massachusetts
United States	CUMC Harkness Pavillion	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Altec Inc.	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Rating of Perceived Difficulty	Structured interviews will be used to grade the perception of difficulty in using the technology	1 day
Primary	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
Primary	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
Primary	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