Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160882
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-08-29
Brief Title:
Powered Prosthesis for Use With TF Osseointegration Recipients
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 flexionextension and ankle plantarflexiondorsiflexion 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 OITMR 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
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 flexionextension and ankle plantarflexiondorsiflexion 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 OITMR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None