Clinical trial NCT04038151: Intuitive Control of a Hybrid Prosthetic Leg During Ambulation
Official title: Intuitive Control of a Hybrid Prosthetic Leg During Ambulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Keywords: Transfemoral Amputation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* A unilateral or bilateral lower limb amputation
* K2/K3/K4 ambulator with a prosthesis
* English speaking

Exclusion Criteria:

* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.

  * Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.

Primary outcomes:
measure: Average daily number of steps
timeFrame: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
measure: Average daily number of times subject switches between activities
timeFrame: 4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: GPS tracking analysis
timeFrame: End of each 4 week home trial
measure: Six-Minute Walk Test
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: Hill Assessment Index
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: Stair Assessment Index
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: Berg Balance Scale
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: Functional Gait Assessment
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: 5 Times Sit to Stand
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: 4 -Square Step Test
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
measure: Amputee Mobility Predictor
timeFrame: Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device
Other outcomes:
measure: Prosthesis Evaluation Questionnaire
timeFrame: Completion of each 4 week home trial
measure: Falls-Efficacy Scale
timeFrame: Completion of each 4 week home trial
measure: Orthotics and Prosthetics User Survey
timeFrame: Completion of each 4 week home trial
measure: World Health Organization Quality of Life Bref
timeFrame: Completion of each 4 week home trial
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Levi Hargrove, PhD
role: PRINCIPAL_INVESTIGATOR
References: