Cerebral Palsy, Gait Disorders, Neurologic
Conditions
Keywords
CP (Cerebral Palsy), Diplegia, Spastic, Gait Disorders
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.
Interventions
DEVICEmPAD (or TPAD) Pelvic Assist Device
Gait retraining device that applies pelvic forces and measures response
DEVICENo Intervention
Gait with no pelvic assistance
Sponsors
Columbia University
Altec Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Metric Accuracy | 1 day | 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 | 1 day | Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture |
| Muscle Activation During Walking | 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 |
| Rating of Perceived Difficulty | 1 day | Structured interviews will be used to grade the perception of difficulty in using the technology |
| Trunk Range of Motion During Walking | 1 day | Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture |
| Hip Range of Motion During Walking | 1 day | Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture |
| Knee Range of Motion During Walking | 1 day | Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Gait with and without pelvic assistance | 0 |
| Controls Gait with no pelvic assistance | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Controls | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants |
| Age, Continuous | 27.3 years STANDARD_DEVIATION 2.8 | 27.3 years STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants |
| Region of Enrollment United States | 10 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 10 |
| other Total, other adverse events | 0 / 0 | 0 / 10 |
| serious Total, serious adverse events | 0 / 0 | 0 / 10 |
Outcome results
Primary
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
Time frame: 1 day
Population: Analysis was conducted for control participants that completed the study procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | Gait Metric Accuracy | 2.01 percentage of error | Standard Deviation 1.44 |
Primary
Hip Range of Motion During Walking
Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture
Time frame: 1 day
Population: Analysis was conducted for control participants that completed the study procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | Hip Range of Motion During Walking | 2.09 degrees | Standard Deviation 0.9 |
Primary
Knee Range of Motion During Walking
Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture
Time frame: 1 day
Population: Analysis was conducted for control participants that completed the study procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | Knee Range of Motion During Walking | 3.12 degrees | Standard Deviation 1.27 |
Primary
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
Time frame: 1 day
Population: Analysis was not conducted since patient participants in need of EMG biofeedback were not recruited.
Primary
Pelvis Range of Motion During Walking
Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture
Time frame: 1 day
Population: Analysis was conducted for control participants that completed the study procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | Pelvis Range of Motion During Walking | 1.40 degrees | Standard Deviation 0.6 |
Primary
Rating of Perceived Difficulty
Structured interviews will be used to grade the perception of difficulty in using the technology
Time frame: 1 day
Population: Analysis was not conducted since patient participants assigned to the pelvic assistance intervention were not recruited.
Primary
Trunk Range of Motion During Walking
Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture
Time frame: 1 day
Population: Analysis was conducted for control participants that completed the study procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | Trunk Range of Motion During Walking | 1.34 degrees | Standard Deviation 0.5 |