Clinical trial NCT04717323: Precision Gait Retraining for Children With Cerebral Palsy
Official title: Precision Gait Retraining for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Gait Disorders, Neurologic
Keywords: CP (Cerebral Palsy)
Diplegia, Spastic
Gait Disorders
Lead sponsor: Altec Inc.
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
First posted: 2021-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Gait Metric Accuracy
timeFrame: 1 day
measure: Pelvis Range of Motion During Walking
timeFrame: 1 day
measure: Muscle Activation During Walking
timeFrame: 1 day
measure: Rating of Perceived Difficulty
timeFrame: 1 day
measure: Trunk Range of Motion During Walking
timeFrame: 1 day
measure: Hip Range of Motion During Walking
timeFrame: 1 day
measure: Knee Range of Motion During Walking
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Natick
country: United States
facility: Altec Inc.
state: Massachusetts
city: New York
country: United States
facility: CUMC Harkness Pavillion
state: New York
Study officials:
affiliation: Altec Inc.
name: Paola Contessa, PhD
role: PRINCIPAL_INVESTIGATOR
References: