Adaptive Recalibration of Prosthetic Leg Neural Control System

NCT02355912 | Completed

• 1 other identifier: STU00101767
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Transfemoral

Outcome Measures

Primary Outcomes (1)

• Decreased error rates for pattern recognition system used to predict ambulation modes

  Pattern recognition algorithms have been used to allow seamless and automatic transitioning between ambulation modes. Classification errors result in the prosthesis predicting the wrong ambulation mode. A decrease in errors results in improved mode prediction by the prosthesis. EMG from the participant and mechanical sensor data from the prosthesis are processed with the use of a phase-based-dependent pattern recognition classification method. The data collection will yield three groups of 10 real-time trials. The investigators primary analysis will be a repeated measures ANOVA with a planned contrast between the groups. The investigators will also complete a secondary analysis using the data collected while the participants ambulated outside of the laboratory. The total number of misclassifications will be computed. This will allow the investigator to evaluate the rate at which the overall classification system adapted.

  Assessed at approximately 2 months and 6 months after enrollment

Study Arms (1)

Evaluate a real-time adaptive neural control system

EXPERIMENTAL

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.

Device: Powered knee and ankle prosthesis

Interventions

Powered knee and ankle prosthesis DEVICE

A powered knee and ankle prosthesis developed by Vanderbilt University.

Evaluate a real-time adaptive neural control system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower Limb Amputees
• K2/K3/K4 ambulators

You may not qualify if:

• 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:
• no injury on either lower extremity
• 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.)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Study Officials

• Levi Hargrove, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neural Engineering for Prosthetics and Orthotics Laboratory

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 4, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

US (1)