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Clinical Trials/NCT04717323
NCT04717323
Completed
Not Applicable

Precision Gait Retraining for Children With Cerebral Palsy

Altec Inc.2 sites in 1 country10 target enrollmentNovember 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Altec Inc.
Enrollment
10
Locations
2
Primary Endpoint
Rating of Perceived Difficulty
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2020
End Date
January 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Altec Inc.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rating of Perceived Difficulty

Time Frame: 1 day

Structured interviews will be used to grade the perception of difficulty in using the technology

Knee Range of Motion During Walking

Time Frame: 1 day

Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture

Gait Metric Accuracy

Time Frame: 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

Time Frame: 1 day

Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture

Muscle Activation During Walking

Time Frame: 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

Time Frame: 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

Time Frame: 1 day

Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture

Study Sites (2)

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