Adaptive Recalibration of Prosthetic Leg Neural Control System

NCT ID: NCT02355912

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-01-31

Brief Summary

The purpose of this study is for transfemoral amputees to walk with an experimental robotic prosthesis. Electric signals will be measured from their muscles and used to help control an artificial leg. The investigators will record from sensors placed on a prosthesis and electric signals measured from muscles in the participants leg to see if the investigators can develop better computer programs to help predict subject actions and prostheses function.

Detailed Description

The investigators propose to use a powered knee-ankle prosthesis that is not yet commercially available. The hierarchical control framework the investigators are developing will be equally applicable to any prosthetic leg that needs to be transitioned between ambulation modes, including microprocessor-controlled passive devices.

The overall objective is to develop and evaluate an adaptive framework for controlling lower limb prostheses that compensates for changes in EMG signals. When a participant walks on a lower limb prosthesis, the output of the high-level controller (or ambulation mode predictor) directly influences patterns generated by the participant. After the participant has completed the subsequent stride, a gait pattern estimator (GPE), will provide a label of what the participant actually did. This may differ from the ambulation mode predictor output if there was a misclassification. The label will then be used to update the ambulation mode predictor algorithm such that future steps are predicted with higher accuracies. Finally, the resulting system will be transferred to an embedded system and tested in real-time with transfemoral amputees and compared to a non-adaptive system.

Conditions

Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Evaluate a real-time adaptive neural control system

The prosthesis will be tuned, for each subject: level-ground walking, walking up and down slopes and walking up and down stairs. We anticipate that participants will visit the laboratory approximately 6-9 times over 2 months (2-3 visits for socket duplications and modifications, 2-3 visits for control system tuning, and an additional 2-3 visits for practice using the tuned system). By the end of these visits, the goal is to have a properly fitting socket and for the subjects to ambulate proficiently with the powered prosthesis. After tuning, the subjects will complete 20 ambulation circuits (level ground walking, walking up and down slopes, up and down stairs). This will provide training data for our pattern recognition control systems.

Group Type: EXPERIMENTAL

Powered knee and ankle prosthesis

Intervention Type: DEVICE

A powered knee and ankle prosthesis developed by Vanderbilt University.

Interventions

Powered knee and ankle prosthesis

A powered knee and ankle prosthesis developed by Vanderbilt University.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Lower Limb Amputees
• K2/K3/K4 ambulators

• no injury on either lower extremity

Exclusion Criteria

• Over 250lbs body weight
• Inactive, physically unfit
• cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments
• Pregnant women
• co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

Able-bodied Subjects:

• inactive, physically unfit
• over 250 lbs body weight
• cognitive deficits or visual impairment that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments
• Pregnant women (status determined by self-reporting)
• co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Levi Hargrove

Director, Neural Engineering for Prosthetics and Orthotics Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Levi Hargrove, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00101767

Identifier Type: -

Identifier Source: org_study_id