Intent Recognition for Prosthesis Control

Sponsor

Georgia Institute of Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05537792

Collaborator

(none)

Enrollment

Location

Arm

18.9

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. The study will compare the performance of the advanced algorithm with their take-home device, as well as with the robotic system that does not use an advanced algorithm.

Condition or Disease	Intervention/Treatment	Phase
Amputation	Device: Robotic Knee/Ankle Prosthesis	N/A

Detailed Description

The focus of this work is a proposed novel artificial intelligence (AI) system to self-adapt an intent recognition system in powered prostheses to aid deployment of intent recognition systems that personalize to individual patient gait. The investigators hypothesize that the prosthesis using our self-adaptive intent recognition system will improve walking speed. Independent community ambulation is known to be more challenging for individuals with transfemoral amputation (TFA), and so the study will measure self-selected walking speed (SSWS) which is a correlate with overall health and is a predictor of functional dependence, mobility disability and falls; furthermore, slow SSWS are correlated to lower quality of life (QOL), decreased participation and symptoms of depression. Self-adapting intent recognition has great potential to restore gait in community settings and improve embodiment, which has been associated with improved QOL and increased device usage in patients who use advanced upper limb prostheses. In this experiment, patients with TFA will be fit with the robotic knee/ankle prosthesis and proceed to walk over a circuit to include level walking, ramp ascent and ramp descent at varying grades and speeds, while the investigators capture 3D biomechanics and completion times with both the self-adaptive and static user-independent system (control condition). A third condition, the patient's clinically prescribed passive prosthetic device (every-day use) will be tested to serve as a baseline to the powered technology. The investigators expect the self-adaptive system to learn the best prediction of the patient's unique gait, leading to advantages in functional and patient reported outcomes over the control and baseline conditions.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The model used is a repeated measures single arm study.The model used is a repeated measures single arm study.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

User-Independent Intent Recognition on a Powered Transfemoral Prosthesis

Anticipated Study Start Date :

Jan 1, 2026

Anticipated Primary Completion Date :

Apr 30, 2027

Anticipated Study Completion Date :

Jul 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Smart Robotic Knee/Ankle Prothesis This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures).	Device: Robotic Knee/Ankle Prosthesis The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.

Arm

Intervention/Treatment

Experimental: Smart Robotic Knee/Ankle Prothesis

This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures).

Device: Robotic Knee/Ankle Prosthesis

The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.

Outcome Measures

Primary Outcome Measures

Self-selected Walking Speed [1 year]
This measures the individuals preferred overground walking speed which indicates their physical capability with a device.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A unilateral transfemoral amputation of the lower limb
Aged between 18 to 75 years, inclusive
K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of the physiatrist and/or prosthetist)

Exclusion Criteria:

Individuals with any significant neuromuscular or musculoskeletal disorder or other comorbidity that would interfere with participation (based on assessment of the physiatrist and/or prosthetist and patient self-report)
Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Exoskeleton and Prosthetic Intelligent Controls Lab	Atlanta	Georgia	United States	30332

Sponsors and Collaborators

Georgia Institute of Technology

Investigators

Principal Investigator: Aaron Young, Ph.D., Georgia Institute of Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgia Institute of Technology

ClinicalTrials.gov Identifier:

NCT05537792

Other Study ID Numbers:

H21117

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Georgia Institute of Technology

Protheses

Amputation

Study Results

No Results Posted as of Sep 13, 2022