NCT04717323

Precision Gait Retraining for Children With Cerebral Palsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Altec Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cerebral Palsy
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
DEVICE	mPAD (or TPAD) Pelvic Assist Device	Gait retraining device that applies pelvic forces and measures response
DEVICE	No Intervention	Gait with no pelvic assistance

Timeline

• Start date: 2020-11-11
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2021-01-22
• Last updated: 2022-03-04
• Results posted: 2021-11-10

Locations

2 sites across 1 country: United States