Comparison of Various Prosthetic Foot-Ankle Mechanisms

NCT05964855 | Enrolling By Invitation FDA Device

• 1 other identifier: 2306001029
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In summary, subjects will be asked to wear a number of sensors and use different ankle-foot prostheses in place of their customary prosthesis. Data will be collected from the wearable sensors, VICON motion capture system, video cameras, and force sensors in the ground as they walk on level-ground, on a treadmill, and on stairs. The controller of any powered prosthesis will be electronically adjusted between trials or while the subject walks to determine how their gait changes in response to these changes. Trials will also be conducted with a standard passive prosthesis that would be prescribed for a person of similar height and weight.

Conditions

Transtibial Amputation - Unilateral

Keywords

Foot-ankle device; prosthesis; mobility

Outcome Measures

Primary Outcomes (3)

• User device preference for level-ground walking

  Determine which device the users prefer for level-ground walking by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.

  From enrollment to the end of trial (2 sessions, 8 hours total per patient)

• User device preference for stair ascent & descent

  Determine which device the users prefer for stair ascent \& descent by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.

  From enrollment to the end of trial (2 sessions, 8 hours total per patient)

• User device preference for sloped ground ascent & descent

  Determine which device the users prefer for 8-degree sloped ground ascent \& descent by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.

  From enrollment to the end of trial (2 sessions, 8 hours total per patient)

Secondary Outcomes (4)

• Effect of device on level-ground walking gait

  From enrollment to the end of trial (2 sessions, 8 hours total per patient)

• Effect of device on stair ascent & descent gait

  From enrollment to the end of trial (2 sessions, 8 hours total per patient)

• Effect of device on sloped ground walking gait

  From enrollment to the end of trial (2 sessions, 8 hours total per patient)

• Effect of device on ground reaction force during ambulation

  From enrollment to the end of trial (2 sessions, 8 hours total per patient)

Study Arms (1)

Unilateral Subject Group

EXPERIMENTAL

Foot-ankle devices will be given to this group to evaluate and compare the devices.

Device: MIT Variable Stiffness Prosthesis; Device: MIT Variable Equilibrium Angle Prosthesis; Device: MIT Sliding Beam Passive Prosthesis; Device: Ossur Pro-flex XC; Device: Blatchford Elan Variable-Dampening Prosthesis

Interventions

MIT Variable Stiffness Prosthesis DEVICE

Proprietary electronically-controlled prosthesis that can vary its effective stiffness.

Unilateral Subject Group

MIT Variable Equilibrium Angle Prosthesis DEVICE

Proprietary manually-controlled prosthesis that can vary its effective ankle equilibrium angle.

Unilateral Subject Group

MIT Sliding Beam Passive Prosthesis DEVICE

Proprietary fixed-stiffness passive foot-ankle prosthesis.

Unilateral Subject Group

Ossur Pro-flex XC DEVICE

Commercially-available passive fixed-stiffness foot-ankle prosthesis by Ossur.

Unilateral Subject Group

Blatchford Elan Variable-Dampening Prosthesis DEVICE

Commercially-available electronically-controlled prosthesis that can vary its effective dampening.

Also known as: Elan

Unilateral Subject Group

Eligibility Criteria

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

You may qualify if:

• Person with unilateral transtibial amputation
• K3 or K4 Medicare mobility rating
• Ages 18-65

You may not qualify if:

• Below K3 Medicare mobility rating
• Outside of age range (liability and safety reasons)

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead

Study Sites (1)

MIT Media Laboratory

Cambridge, Massachusetts, 02139, United States

Location

Study Design

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

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 28, 2023
• Study Start: July 28, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (1)