Precision Gait Retraining for Children With Cerebral Palsy

Not Applicable

Completed

Conditions: Gait Disorders, Neurologic
Cerebral Palsy

Interventions: Device: mPAD (or TPAD) Pelvic Assist Device
Device: No Intervention

Registration Number: NCT04717323

Lead Sponsor: Altec Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	No Intervention	Gait with and without pelvic assistance
Patients	mPAD (or TPAD) Pelvic Assist Device	Gait with and without pelvic assistance
Controls	No Intervention	Gait with no pelvic assistance

Primary Outcome Measures

Name	Time	Method
Rating of Perceived Difficulty	1 day	Structured interviews will be used to grade the perception of difficulty in using the technology
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
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
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