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Precision Gait Retraining for Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mPAD (or TPAD) Pelvic Assist Device
No Intervention
Sponsored by
Altec Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy focused on measuring CP (Cerebral Palsy), Diplegia, Spastic, Gait Disorders

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Altec Inc.
  • CUMC Harkness Pavillion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

Controls

Arm Description

Gait with and without pelvic assistance

Gait with no pelvic assistance

Outcomes

Primary Outcome Measures

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
Pelvis Range of Motion During Walking
Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture
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
Rating of Perceived Difficulty
Structured interviews will be used to grade the perception of difficulty in using the technology
Trunk Range of Motion During Walking
Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture
Hip Range of Motion During Walking
Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture
Knee Range of Motion During Walking
Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
February 23, 2022
Sponsor
Altec Inc.
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT04717323
Brief Title
Precision Gait Retraining for Children With Cerebral Palsy
Official Title
Precision Gait Retraining for Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altec Inc.
Collaborators
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Gait Disorders, Neurologic
Keywords
CP (Cerebral Palsy), Diplegia, Spastic, Gait Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Gait with and without pelvic assistance
Arm Title
Controls
Arm Type
Experimental
Arm Description
Gait with no pelvic assistance
Intervention Type
Device
Intervention Name(s)
mPAD (or TPAD) Pelvic Assist Device
Other Intervention Name(s)
mPAD (or TPAD)
Intervention Description
Gait retraining device that applies pelvic forces and measures response
Intervention Type
Device
Intervention Name(s)
No Intervention
Intervention Description
Gait with no pelvic assistance
Primary Outcome Measure Information:
Title
Gait Metric Accuracy
Description
Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture
Time Frame
1 day
Title
Pelvis Range of Motion During Walking
Description
Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture
Time Frame
1 day
Title
Muscle Activation During Walking
Description
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
Time Frame
1 day
Title
Rating of Perceived Difficulty
Description
Structured interviews will be used to grade the perception of difficulty in using the technology
Time Frame
1 day
Title
Trunk Range of Motion During Walking
Description
Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture
Time Frame
1 day
Title
Hip Range of Motion During Walking
Description
Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture
Time Frame
1 day
Title
Knee Range of Motion During Walking
Description
Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Contessa, PhD
Organizational Affiliation
Altec Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altec Inc.
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Facility Name
CUMC Harkness Pavillion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Precision Gait Retraining for Children With Cerebral Palsy

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