Intent Recognition for Prosthesis Control

NCT05537792 | Completed Results FDA Device

• 2 other identifiers: H21117DP2HD111709
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 investigators will compare the performance of the advanced algorithm with the robotic system that does not use an advanced algorithm.

Conditions

Amputation

Keywords

Protheses; Amputation

Outcome Measures

Primary Outcomes (1)

• Overground Self-selected Walking Speed

  This measures the individuals preferred overground walking speed which indicates their physical capability with a device.

  1 day

Secondary Outcomes (2)

• Overground Walking Speed Mean Absolute Error (MAE)

  1 day

• Treadmill Walking Speed Mean Absolute Error (MAE)

  1 day

Study Arms (1)

Smart Robotic Knee/Ankle Prothesis

EXPERIMENTAL

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

Interventions

Robotic Knee/Ankle Prosthesis DEVICE

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.

Smart Robotic Knee/Ankle Prothesis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A unilateral 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)
• If a prosthesis is used, the participant must use a prosthetic knee and foot in their clinically prescribed prosthesis.

You may not qualify if:

• Individuals with history of neurological injury, gait pathology, or cardiovascular condition that would limit ability to ambulate for multiple hours
• Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Exoskeleton and Prosthetic Intelligent Controls Lab

Atlanta, Georgia, 30332, United States

Location

Limitations and Caveats

A limitation of this study involved the lack of real-time adaptation and evaluation of forward estimators during overground walking. Future studies should evaluate forward estimators in real-time for longer bouts of walking.

Results Point of Contact

• Title: Dr. Aaron Young
• Organization: Georgia Institute of Technology

aaron.young@me.gatech.edu

404.385.5306

Study Officials

• Aaron Young, Ph.D.

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The model used is a repeated measures single arm study.

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: September 1, 2023
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: October 2, 2024
• Results First Posted: October 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)