Status:
COMPLETED
Precision Gait Retraining for Children With Cerebral Palsy
Lead Sponsor:
Altec Inc.
Collaborating Sponsors:
Columbia University
Conditions:
Cerebral Palsy
Gait Disorders, Neurologic
Eligibility:
All Genders
6+ years
Phase:
NA
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 movemen...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04717323
Start Date
November 11 2020
End Date
January 31 2021
Last Update
March 4 2022
Active Locations (2)
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1
Altec Inc.
Natick, Massachusetts, United States, 01760
2
CUMC Harkness Pavillion
New York, New York, United States, 10032