American company conducts a clinical trial of Precision Gait Retraining for Children With Cerebral Palsy

Photo by Jessica Rockowitz

Altec Inc. is starting a new clinical trial of Precision Gait Retraining for Children With Cerebral Palsy.

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.

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.

Among the exclusion criteria are (children with CP):

• 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 test42 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.

and others.

The clinical trial started in November 11, 2020 and will continue throughout January 2021.

The contacts and locations are the Altec Inc, Natick, Massachusetts and CUMC Harkness Pavillion, New York, New York, United States.

For more complete information please follow the link to the study: https://ichgcp.net/clinical-trials-registry/NCT04717323