Precision Gait Retraining for Children With Cerebral Palsy

NCT04717323 | Completed Results

• 1 other identifier: mPAD Phase 1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Keywords

CP (Cerebral Palsy); Diplegia, Spastic; Gait Disorders

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Patients

EXPERIMENTAL

Gait with and without pelvic assistance

Device: mPAD (or TPAD) Pelvic Assist Device; Device: No Intervention

Controls

EXPERIMENTAL

Gait with no pelvic assistance

Device: No Intervention

Interventions

mPAD (or TPAD) Pelvic Assist Device DEVICE

Gait retraining device that applies pelvic forces and measures response

Also known as: mPAD (or TPAD)

Patients

No Intervention DEVICE

Gait with no pelvic assistance

Controls; Patients

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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;

Sponsors & Collaborators

• Altec Inc.: lead
• Columbia University: collaborator

Study Sites (2)

Altec Inc.

Natick, Massachusetts, 01760, United States

Location

CUMC Harkness Pavillion

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic; Mobility Limitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Intervention was not assigned due to mandated patient recruitment restrictions resulting from the Covid-19 emergency.

Results Point of Contact

• Title: Dr. Paola Contessa
• Organization: Altec Inc.

pcontessa@altecresearch.com

5085458236

Study Officials

• Paola Contessa, PhD

  Altec Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: January 22, 2021
• Study Start: November 11, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: March 4, 2022
• Results First Posted: November 10, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be made through conferencing

Locations

US (2)