Intuitive Control of a Hybrid Prosthetic Leg During Ambulation

NCT04038151 | Recruiting

• 2 other identifiers: STU002095222R01HD079428-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Transfemoral Amputation

Outcome Measures

Primary Outcomes (2)

• Average daily number of steps

  This outcome will be assessed using an accelerometery data measured using a mobile phone during the entire 4-week home trial of each device (Hybrid Leg and prescribed home device), resulting in a pair of outcomes for each subject. Statistical analysis will be done , first using a paired t-test (which assumes no carry-over and no device sequence effects), followed by the analysis using a linear mixed model with device and sequence group as fixed effects, and subject as the random effect. We expect that sequence will not be a statistically significant predictor, but that average daily steps will be significantly different between devices, with subjects taking significantly more steps when using the Hybrid Leg.

  4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial

• Average daily number of times subject switches between activities

  This outcome will be assessed using an accelerometery data measured using a mobile phone during the entire 4-week home trial of each device (Hybrid Leg and prescribed home device), resulting in a pair of outcomes for each subject. Statistical analysis will be done , first using a paired t-test (which assumes no carry-over and no device sequence effects), followed by the analysis using a linear mixed model with device and sequence group as fixed effects, and subject as the random effect. We expect that sequence will not be a statistically significant predictor, but that average transitions will be significantly different between devices, with subjects taking significantly more transitioning between activities more when using the Hybrid Leg.

  4 weeks - data collected during 4 week home trial of each device, analyzed upon completion of 4 week home trial

Secondary Outcomes (10)

• 10 Meter Walk Test

  Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device

• GPS tracking analysis

  End of each 4 week home trial

• Six-Minute Walk Test

  Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device

• Hill Assessment Index

  Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device

• Stair Assessment Index

  Lab visit prior to start of home trial and lab visit upon completion of 4 week trial with each device

Other Outcomes (4)

• Prosthesis Evaluation Questionnaire

  Completion of each 4 week home trial

• Falls-Efficacy Scale

  Completion of each 4 week home trial

• Orthotics and Prosthetics User Survey

  Completion of each 4 week home trial

Study Arms (2)

Condition A: Hybrid Leg

EXPERIMENTAL

Subject will be trained on use of the experimental device, the Hybrid Leg.

Device: Hybrid Leg

Condition B: Passive Leg

OTHER

Subject will use their currently prescribed home passive prosthesis

Device: Prescribed Passive Prosthesis

Interventions

Hybrid Leg DEVICE

The Hybrid Knee uses an actively variable transmission in combination of a passive spring/damper system. This allows the motor torque output to be adapted to the requirements of active dynamic tasks - changing the effective transmission ration from zero (fully passive) for level ground walking to a maximum value (fully active) for sit-to-stand transfers. This provides physiological knee torque and speed with a small motor and primary transmission system while also maximizing electrical efficiency, which minimized battery weight. The knee prototype weights 1.7kg. The Semi-active ankle can actively reposition during non-weight bearing phases of gait and uses a non back driveable transmission to maintain its set point during weight bearing activities.

Condition A: Hybrid Leg

Prescribed Passive Prosthesis DEVICE

Participants will participate in training sessions of community skills and advanced ambulation training for their home, prescribed passive prosthesis.

Condition B: Passive Leg

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Study Officials

• Levi Hargrove, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Finucane

CONTACT

312-238-0937; sfinucane@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Regenstein Center for Bionic Medicine

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 30, 2019
• Study Start: December 1, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 2 years of study completion
• Access Criteria: Data requests will be reviewed by the NU IRB and requester may need to sign a data access agreement.

Locations

US (1)