Intuitive Control of a Hybrid Prosthetic Leg During Ambulation

Status Recruiting

Clinical Trial Summary

The objective of this research is to determine the clinical benefits of an innovative and lightweight powered leg controlled using our intent recognition framework in laboratory and community environments.

Clinical Trial Description

The hypothesis of this study is that using the Hybrid Leg with seamless, automatic transitions will result in participants choosing to become more active and improve their community participation compared to when using their own passive prosthetic leg. The Hybrid Leg is an an innovative and lightweight powered leg that has 2 operating modes: active and passive. When in active mode, the Hybrid Leg is capable of supplying 120 NM of knee torque and actively repositioning the ankle during non-weight bearing phases of gait. When in passive mode, the motor and transmission are decoupled from the knee, which then behaves like an Ottobock 3R95 passive prosthetic knee, and the non-backdriveable mechanism of the ankle allows it to behave as an energy return foot. Allowing the device to behave passively if the battery becomes depleted or the actuators become damaged is an important enabling safety factor that will allow us to complete our study. Phase 1: We will enroll 20 subjects a clinical trial of the leg and control system who will be fit with the Hybrid Leg and receive in-lab therapy to learn how to ambulate with the device. Phase 2: Subjects will be randomized into a clinical trial of the leg and control system with an AB-BA design; condition A - subjects own device; condition B - Hybrid Leg. Subjects will complete an extensive ambulation and community mobility training to learn optimal use of their own passive device or the Hybrid Leg. After training the subjects will complete a full biomechanical analysis for each device as they complete ambulation circuits that include standing, level-ground walking, walking on slopes and on stairs, sit-stand transitions and transitions between these activities. Phase 3: After completing phase 2 subjects will complete 4-week trials using their assigned prosthesis (Condition A or B) at home and within their community. During the trials subjects will be monitored using mobile phone based sensors and socket mounted activity monitor to determine how often the user performs the ambulation activities. ;

Study Design

Related Conditions & MeSH terms

Amputation

Clinical Trial Details

NCT number	NCT04038151
Study type	Interventional
Source	Shirley Ryan AbilityLab
Contact	Suzanne Finucane
Phone	312-238-0937
Email	sfinucane@sralab.org
Status	Recruiting
Phase	N/A
Start date	December 1, 2018
Completion date	June 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.