Powered Prosthesis for Use With TF Osseointegration Recipients

Amputation Clinical Trial

Official title: Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate functional mobility, control, and user satisfaction from persons who have an amputation above the knee and have received osseo-integration (OI) and targeted muscle reinnervation (TMR) surgery, while walking with a powered knee and ankle prosthesis.

Clinical Trial Description

The objective of this study is to evaluate functional mobility, non-weight-bearing neural control, and user satisfaction from individuals with unilateral transfemoral amputation who have received osseo-integration (OI) and targeted muscle reinnervation (TMR), while ambulating with a fully powered prosthesis. The hypothesis is that OI will show perceived benefits for participants including: 1) lower perceived weight of the prosthesis due to the more secure OI interface over a traditional socket, 2) decreased energy expenditure during ambulation and transitions, and 3) electromyographic (EMG) signals will be higher quality and more robust than signals measured from within a socket, potentially allowing for improved pattern recognition driven prostheses in future device design and studies. Prior to surgical intervention, amputee participants will visit the lab up to 3 times for socket fitting, and at most 7 times to practice using the powered prosthesis and collect experimental data. There is no time limitation between sessions and each session will last a maximum of 4 hours. Aim 1: Pre-Surgery Fitting and Powered Leg Prosthesis Training: Participants will be fit for a custom instrumented socket that allows for collection of surface EMG signals and for use with the powered lower limb prosthesis. The socket that is fabricated is solely for the purpose of this study, will be used only in the research lab. The participant will continue to use their clinically prescribed socket and prosthesis when not attending study visits. EMG control sites over the semitendinosus, biceps femoris, tensor fasciae latae, rectus femoris, vastus lateralis, and adductor magnus will be located using clinical best practices. Once socket fit is completed, the prosthetist will attach and align the powered prosthesis. The participant will be instructed to walk with the powered prosthesis for level ground walking, incline walking, stair climbing and non-weight bearing independence control activities. The walkway, ramps and stairs are equipped with handrails and the amputee with be wearing either an overhead harness or gait belt for safety. Additionally, a non-weight bearing independent control system will be configured. The participant will be instructed to attempt to move their 'phantom' limb through knee flexion/extension and ankle plantarflexion/dorsiflexion range movements while EMG data are collected. These data are used to train a pattern recognition control system which can control the leg knee and ankle joints respectively, either in a virtual environment or with the physical prosthesis. The participants will then complete functional, biomechanical, metabolic, and qualitative patient reported outcome measures using the instrumented socket and the powered leg prosthesis. The investigator will use an extensive list of standard clinical assessments and participant-reported measures that assess physical function, mobility, balance, fall risk, quality of life, and metabolic expenditure. OI TMR surgery 1 and recovery: participants will undergo the first osseointegration (OI) and targeted muscle reinnervation (TMR) surgery at Northwestern Memorial Hospital. OI surgery 2 and recovery: Participants will undergo the second OI surgery where the abutment will be connected to the fixture with in the femur. The participant will again be monitored for full recovery (typically 4-6 weeks). No outcome measures or assessments will be performed prior to 12 weeks' post-surgery Aim 2: Post-Surgery Fitting and Powered Leg Prosthesis Training: After osseointegration and TMR surgery and recovery, the study participant no longer requires a standard prosthetic socket. EMG signals can now be measured using a custom fit electrode band on the residual limb that is tethered to the prosthesis. Participants will be fit with the powered prosthesis using their OI interface and trained on its use. Participants will receive instruction on use of the powered prosthesis, now attached via their OI interface with the electrode band. The participants will walk under the supervision of a clinician while device parameters are configured as prior to OI/TMR surgery. The participant will progress to walking over slopes, perform stairclimbing with a reciprocal gait and sit to and from standing transitions. The clinician will provide verbal instruction and cues on how to best make use of the power and how to safely perform all activities. The investigators will repeat the same measures as previously performed to evaluate the functional, metabolic, and biomechanical benefits conferred by OI over a traditional socket when using a powered leg device. At the end of each visit, the study participant will return to their clinically prescribed prosthesis. ;

Related Conditions & MeSH terms

• Amputation

• NCT number: NCT06160882
• Study type: Interventional
• Source: Shirley Ryan AbilityLab
• Contact: Suzanne Finucane, MS, PTA
• Phone: 312-238-0937
• Email: sfinucane@sralab.org
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: October 2028