Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction

NCT03204513 | Active Not Recruiting

• 1 other identifier: STU00200842
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this research is to determine the efficacy of new powered prosthetic devices for individuals with transfemoral amputations. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics. The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using PKA prosthesis and quantify functional performance and quality of life changes.

Conditions

Transfemoral Amputees

Keywords

Prosthesis; Powered Prosthesis

Outcome Measures

Primary Outcomes (2)

• Change between devices of the Modified Graded Treadmill Test

  This test is used to determine participant's endurance while walking at different speeds on a motorized treadmill. Participants will be secured to an overhead safety harness during this test. Participants will walk for up to 2 minutes each at different speeds on the treadmill. The treadmill speeds will be varied between 0.2 meters/second up to 2.0 meters/second at increments of 0.2 meters/sec. Close to the end of every 2 minute walk period, the participant will be asked to rate the perceived exertion for the walking task. Before incrementing the speed and continuing with the test, participants will be asked if participants would like to continue to walk and if the speed can be incremented. Participants metabolic and heart rate will be monitored frequently and recorded during this test. A physical exertion rating scale will be used to record participant's perceived exertion during every 2 minutes throughout the trial.

  Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

• Change in Biomechanical Assessment [Gait Parameters and Surface Electromyography (EMG) Activation] Between Devices

  Surface EMG recording of specific muscles will be recorded during walking. The EMG electrodes detect electrical signals of the muscles. Reflective markers will be placed at specific locations on the upper and lower extremity joint/bony landmarks to record the motion while walking. The locations of the markers in space will be recorded by an infrared based multi-camera system during walking indoors on tile and over force plates.

  Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

Secondary Outcomes (14)

• Change in Manual Muscle Test (MMT)

  Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

• Change in Passive Range of Motion (PROM)

  Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

• Change in Active Range of Motion (AROM)

  Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

• 6 Minute Walk Test (6MWT) with COSMED K4B2 Metabolic unit

  Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

• Hill Assessment Index (HAI)

  Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

Other Outcomes (10)

• Modified Falls Efficacy Scale (mFES)

  Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

• Prosthesis Evaluation Questionnaire (PEQ)

  Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

• Orthotics & Prosthetics User Survey (OPUS)

  Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)

Study Arms (2)

Vanderbilt Powered Knee-Ankle Prosthesis

EXPERIMENTAL

Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using the Vanderbilt Powered Knee-Ankle (PKA) Prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions using the Vanderbilt Powered Knee-Ankle (PKA) Prosthesis. The device participants begin with will be randomly selected but there will be an equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.

Device: Vanderbilt Powered Knee-Ankle Prosthesis

Microprocessor (MP) Knee Prosthesis

ACTIVE COMPARATOR

Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using their own Microprocessor (MP) Knee Prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions using the Microprocessor (MP) Knee Prosthesis. The device participants begin with will be randomly selected but there will be an equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.

Device: Microprocessor (MP) Knee Prosthesis

Interventions

Vanderbilt Powered Knee-Ankle Prosthesis DEVICE

The Vanderbilt powered prosthesis is a transfemoral prosthesis with powered and coordinated knee and ankle joints. The Generation 3 prosthesis is actuated by two brushless direct current (DC) motors, providing up to 100 Nm of torque at the knee joint, and with the assistance of a parallel stiffness, up to 200 Nm in plantar flexion at the ankle. Sensors measure knee and ankle joint angles, axial load in the shank, and position and orientation of the prosthesis in space (via a 6-axis inertial measurement unit). An onboard lithium-ion battery provides sufficient energy for approximately 10,000 steps between battery charges. The prosthesis prototype weighs approximately 4.3 kg (9.5 lb), the mass of which is approximately equivalent to the intact limb of a 48 kg (105 lb) person.

Also known as: PKA Prosthesis, Powered Knee-Ankle Prosthesis

Vanderbilt Powered Knee-Ankle Prosthesis

Microprocessor (MP) Knee Prosthesis DEVICE

Participants enrolled will already have their own microprocessor controlled (MP) non-powered knee prostheses as per inclusion criteria. Examples: OttoBock's C-Leg, Ossur's Rheo, Freedom Plie, Endolite Orion,etc.

Microprocessor (MP) Knee Prosthesis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transfemoral level limb loss or limb difference
• K2/K3/K4 level ambulators
• Required to use a microprocessor knee on their prosthesis

You may not qualify if:

• Over 250 lbs body weight
• Inactive, physically unfit
• Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments
• Pregnant women
• Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Knee Prosthesis

Intervention Hierarchy (Ancestors)

Joint Prosthesis; Prostheses and Implants; Equipment and Supplies

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using their own microprocessor (MP) knee prosthesis and the powered knee-ankle (PKA) prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions per device. The device participants begin with will be randomly selected but there will be equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 2, 2017
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)