Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452186
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-01-29
Brief Title:
Restoration of Normative Postural Control
Sponsor:
North Carolina State University
Organization:
North Carolina State University
Study Overview
Official Title:
Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles
Status:
RECRUITING
Status Verified Date:
2024-06
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 objective of this proposal is to investigate the effects of training to use direct electromyographic dEMG control of a powered prosthetic ankle on transtibial amputees
The aimed questions to answer
1 whether dEMG control will improve balance and postural stability of amputees
2 whether dEMG control will lead to more natural neuromuscular control and coordination 3 whether dEMG control will reduce cognitive processes
Participants will go through PT guided training on using dEMG controlled prosthetic ankles and are evaluated for their capability on functional tasks
The results will be compared with a comparison group which goes through the same training but with their everyday passive prostheses on balance capability neuromuscular coordination and cognitive load during locomotion
The aimed questions to answer
1 whether dEMG control will improve balance and postural stability of amputees
2 whether dEMG control will lead to more natural neuromuscular control and coordination 3 whether dEMG control will reduce cognitive processes
Participants will go through PT guided training on using dEMG controlled prosthetic ankles and are evaluated for their capability on functional tasks
The results will be compared with a comparison group which goes through the same training but with their everyday passive prostheses on balance capability neuromuscular coordination and cognitive load during locomotion
Detailed Description:
Lab Visit Experience for Participants with lower limb amputation
Number of Lab Visits 15 visits Clinicians may recommend skipping some of the visits or tasks based on clinical evaluation and status of the participants
Length of Lab Visit three hours maximum
1 First visit the purpose of the first visit is to conduct consent and conduct measurements to decide walking speed and ABC amputee balance confidence score
2 Second visit this visit is to ensure that the amputees own socket system can be integrated into the powered prosthetic leg and validate the effectiveness of the EMG interface
3 Third and fourth visits baseline evaluation with powered prosthesis and passive prosthesis Each participant will finish the two visits One of the visits is dedicated to their own passive prosthesis and the other visit is for the powered prosthesis The sequence of the evaluation is randomized The tasks conducted in the two visits are generally identical The only difference is that one of the visits uses the participants everyday prosthetic foot and the other uses the powered prosthetic ankle
4 Fifth and sixth visits these visits are dedicated to have the participants trained to regain muscle coordination which is critical to use the powered prosthetic ankle All the participants will go through these trainings Based on whether the participants are selected as the powered prosthetic group Group A or the passive group Group B the participants will finish this training with the powered prosthetic leg or a passive prosthetic leg
5 Seven - eleventh visits These visits are designed to give participants needed training so participants are able to integrate the action of the powered prosthetic ankle with their full body motion for various tasks To ensure that contribution of the training procedure to the performance changes are considered all the participants will go through the training with the prostheses aligned with their group
6 Twelfth-thirteenth visit duplicate of Third and fourth visit These visits are used to evaluate the impact of the training program on the performance of the participants to conduct tasks which are not included in the training procedure Each participant will conduct the task with both passive and powered prosthetic legs on different days
7 Fourteenth-fifteenth visits duplicate of Third and fourth visit These visits are used to understand the long term effects of the training program on the participants These visits will be conducted three months after the 13th visits
Number of Lab Visits 15 visits Clinicians may recommend skipping some of the visits or tasks based on clinical evaluation and status of the participants
Length of Lab Visit three hours maximum
1 First visit the purpose of the first visit is to conduct consent and conduct measurements to decide walking speed and ABC amputee balance confidence score
2 Second visit this visit is to ensure that the amputees own socket system can be integrated into the powered prosthetic leg and validate the effectiveness of the EMG interface
3 Third and fourth visits baseline evaluation with powered prosthesis and passive prosthesis Each participant will finish the two visits One of the visits is dedicated to their own passive prosthesis and the other visit is for the powered prosthesis The sequence of the evaluation is randomized The tasks conducted in the two visits are generally identical The only difference is that one of the visits uses the participants everyday prosthetic foot and the other uses the powered prosthetic ankle
4 Fifth and sixth visits these visits are dedicated to have the participants trained to regain muscle coordination which is critical to use the powered prosthetic ankle All the participants will go through these trainings Based on whether the participants are selected as the powered prosthetic group Group A or the passive group Group B the participants will finish this training with the powered prosthetic leg or a passive prosthetic leg
5 Seven - eleventh visits These visits are designed to give participants needed training so participants are able to integrate the action of the powered prosthetic ankle with their full body motion for various tasks To ensure that contribution of the training procedure to the performance changes are considered all the participants will go through the training with the prostheses aligned with their group
6 Twelfth-thirteenth visit duplicate of Third and fourth visit These visits are used to evaluate the impact of the training program on the performance of the participants to conduct tasks which are not included in the training procedure Each participant will conduct the task with both passive and powered prosthetic legs on different days
7 Fourteenth-fifteenth visits duplicate of Third and fourth visit These visits are used to understand the long term effects of the training program on the participants These visits will be conducted three months after the 13th visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None