Precision Gait Retraining for Children With Cerebral Palsy

February 23, 2022 updated by: Altec Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gait Metric Accuracy
Time Frame: 1 day
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
Time Frame: 1 day
Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture
1 day
Muscle Activation During Walking
Time Frame: 1 day
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
Time Frame: 1 day
Structured interviews will be used to grade the perception of difficulty in using the technology
1 day
Trunk Range of Motion During Walking
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 1 day
Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Altec Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paola Contessa, PhD, Altec Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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