Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182202
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2022-07-08
Brief Title:
Comparing Intact and Residual Amputated Muscle
Sponsor:
North Carolina State University
Organization:
North Carolina State University
Study Overview
Official Title:
Comparing Intact and Residual Amputated Neuromuscular Physiology
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Lower limb amputees rely on their prosthetic to remain active and lead an independent life In recent years measuring residual muscle activity has been used to interpret a users intent and thereby modulate prosthesis control However little knowledge is held on how residual muscle activity differs from non-amputated muscle The research team will analyze and compare neuromuscular physiology in non-amputee individuals and amputees non-amputated and residual muscles across functional tasks to better understand how amputees control their muscles Such information will inform design of modern prosthesis controllers
Detailed Description:
There will be approximately 80 participants in this study 40 who have lower-limb amputations and 40 who do not
A minimum of 48 hours will separate each testing session
A warm-up is incorporated into every session and subjects will regularly take breaks between trials The research team will check in with them regularly and they are welcome to tell us when they want a break or stop at any time for any reason
Subjects will be asked to conducted controlled isolated muscle activity of their ankle muscles given feedback of their muscle activation to control their effort and prevent fatigue Following activity of isolated muscles subjects will be asked to conduct functional tasks including quiet standing postural sways sitting down and standing up squats heel-raises and walking
Individuals with amputation will conduct the tasks with their personal passive prosthesis device as well as a powered active prosthesis following socket fitting and appropriate adjustment to comfort by a certified trained prosthetist to compare muscle activity in functional tasks Individuals without amputation will conduct the tasks for further comparison
Surface electromyography ultrasound and motion capture data will be used to record muscle activation muscle architecture and joint biomechanics respectively and evaluate observations and effects between residual and intact muscles
More details are below
-- The following sensorsdevices will be attached for the study The sensors will be fixed via a double-sided adhesive self-adhesive wraps or straps All are easily removable and adjustable for their comfort Wearing shorts is recommended to simplify the process of adding sensors
1 Muscle Activation While Sitting Session 1
a Muscle Activity Sensors i Number 4 ii Placement 1 on the front and back of the leg below the knee
2 Muscle Activation While Sitting Sessions 2-3
a Muscle Activity Sensors i Same as Session 1 b Joint Dynamics Device i Subjects on-amputated foot will be strapped into a platform that measures how much they are pullingpushing or moving their ankle On tasks thinking about activating the phantom limb the research team will ask participants to match activities with both limbs so that the research team can record what the participants are thinking about with the phantom limb via the non-amputated foot
c Muscle shape sensors i Number 2 ultrasound probes ii Placement On the front and back of their leg switching legs between sessions
3 Prosthesis Fitting Sessions 4-6
a Muscle Activity Sensors i Same as Session 1 b Socket i A trained prosthetist will cast and fit a socket designed to safely fit the muscle activity sensors
c Powered Prosthesis Device i A trained prosthetist will assist aligning the casted socket with a powered prosthesis the research team have in the lab
4 Functional Tasks Sessions 7-16
a Muscle Activity Sensors i Number 18 ii Placement 1 on the front and back of the leg below the knee 2 on the front of the leg above the knee 1 on the back of the leg below the knee 5 per leg 2 on the arm above and below the elbow 4 per arm b Socket i Fitted in earlier sessions c Powered Prosthesis Device i Fitted and aligned in earlier sessions d Movement measurement markers i Number 40 in total ii Placement 4 on head 5 on torso 7 on each arm 5 on hips 3 on each leg 1 on each ankle toes and heels on the shoe
e Harness i A harness attached to the ceiling will be used to catch subjects case of any fall during the experiment
During each visit the research team will ask subjects to do all the following
1 Muscle Activation While Sitting Sessions 1-3 Come to the lab for 3 initial sessions where they will
1 Practice muscle activation of their ankle muscles while wearing sensors measuring their muscle activity and shape There will be a brief calibration to their maximum effort to ensure muscle activation will be less than maximum effort throughout the rest of the study
2 The research team will provide them with visual biosignal feedback to guide them how to control their muscles
2 Prosthesis Fitting Sessions 4-6 Attend a session where a trained prosthetist will cast their residual limb for a socket followed by 1 2 or 3 fitting up to 3 total sessions with their socket and a powered prosthesis with a certified prosthetist Each visit will last up to two hours The prosthetist will duplicate their current socket and ask them to wear it with a powered prosthesis The prosthetist will also conduct modifications if they do not like the socket to ensure fit and their comfort while wearing the socket
3 Functional Tasks Sessions 7-16 Once the fit has been finalized the participants will come to the lab for up to 10 additional sessions for functional tasks During each visit the participants will be asked to practice modulating and controlling the activation of the amputated and non-amputated muscles After training and practicing activating and controlling the muscles the research team will then ask the participants to conduct the following tasks
1 Quiet standing not moving
2 Postural sway leaning forward and backward
3 Sitting down and standing up repeatedly
4 Squatting
5 Standing up on toes heel-raises
6 Walking on a treadmill at their preferred walking speed
Handrails both left and right will be always available to allow balance support if needed and additional harness protection is available
Individuals without amputation will conduct the functional tasks set once Individuals with amputation will be asked to do the functional task set both with their passive prosthesis and a powered prosthesis to determine if the powered device improves functional performance in addition to compare to individuals without amputation At times the research team will give them auditory feedback to help the participants time the motion and visual biosignal feedback to guide them on how the participants place the weight between legs
The research team expect the participants to come in for up to additional 10 sessions for these activities to account for adaptations in performance when using a powered prosthesis and post-training evaluations of their amputated and non-amputated muscles This estimate also accommodates necessary setup and take-down time that subjects must be present for while maintaining reasonable individual session periods
A minimum of 48 hours will separate each testing session
A warm-up is incorporated into every session and subjects will regularly take breaks between trials The research team will check in with them regularly and they are welcome to tell us when they want a break or stop at any time for any reason
Subjects will be asked to conducted controlled isolated muscle activity of their ankle muscles given feedback of their muscle activation to control their effort and prevent fatigue Following activity of isolated muscles subjects will be asked to conduct functional tasks including quiet standing postural sways sitting down and standing up squats heel-raises and walking
Individuals with amputation will conduct the tasks with their personal passive prosthesis device as well as a powered active prosthesis following socket fitting and appropriate adjustment to comfort by a certified trained prosthetist to compare muscle activity in functional tasks Individuals without amputation will conduct the tasks for further comparison
Surface electromyography ultrasound and motion capture data will be used to record muscle activation muscle architecture and joint biomechanics respectively and evaluate observations and effects between residual and intact muscles
More details are below
-- The following sensorsdevices will be attached for the study The sensors will be fixed via a double-sided adhesive self-adhesive wraps or straps All are easily removable and adjustable for their comfort Wearing shorts is recommended to simplify the process of adding sensors
1 Muscle Activation While Sitting Session 1
a Muscle Activity Sensors i Number 4 ii Placement 1 on the front and back of the leg below the knee
2 Muscle Activation While Sitting Sessions 2-3
a Muscle Activity Sensors i Same as Session 1 b Joint Dynamics Device i Subjects on-amputated foot will be strapped into a platform that measures how much they are pullingpushing or moving their ankle On tasks thinking about activating the phantom limb the research team will ask participants to match activities with both limbs so that the research team can record what the participants are thinking about with the phantom limb via the non-amputated foot
c Muscle shape sensors i Number 2 ultrasound probes ii Placement On the front and back of their leg switching legs between sessions
3 Prosthesis Fitting Sessions 4-6
a Muscle Activity Sensors i Same as Session 1 b Socket i A trained prosthetist will cast and fit a socket designed to safely fit the muscle activity sensors
c Powered Prosthesis Device i A trained prosthetist will assist aligning the casted socket with a powered prosthesis the research team have in the lab
4 Functional Tasks Sessions 7-16
a Muscle Activity Sensors i Number 18 ii Placement 1 on the front and back of the leg below the knee 2 on the front of the leg above the knee 1 on the back of the leg below the knee 5 per leg 2 on the arm above and below the elbow 4 per arm b Socket i Fitted in earlier sessions c Powered Prosthesis Device i Fitted and aligned in earlier sessions d Movement measurement markers i Number 40 in total ii Placement 4 on head 5 on torso 7 on each arm 5 on hips 3 on each leg 1 on each ankle toes and heels on the shoe
e Harness i A harness attached to the ceiling will be used to catch subjects case of any fall during the experiment
During each visit the research team will ask subjects to do all the following
1 Muscle Activation While Sitting Sessions 1-3 Come to the lab for 3 initial sessions where they will
1 Practice muscle activation of their ankle muscles while wearing sensors measuring their muscle activity and shape There will be a brief calibration to their maximum effort to ensure muscle activation will be less than maximum effort throughout the rest of the study
2 The research team will provide them with visual biosignal feedback to guide them how to control their muscles
2 Prosthesis Fitting Sessions 4-6 Attend a session where a trained prosthetist will cast their residual limb for a socket followed by 1 2 or 3 fitting up to 3 total sessions with their socket and a powered prosthesis with a certified prosthetist Each visit will last up to two hours The prosthetist will duplicate their current socket and ask them to wear it with a powered prosthesis The prosthetist will also conduct modifications if they do not like the socket to ensure fit and their comfort while wearing the socket
3 Functional Tasks Sessions 7-16 Once the fit has been finalized the participants will come to the lab for up to 10 additional sessions for functional tasks During each visit the participants will be asked to practice modulating and controlling the activation of the amputated and non-amputated muscles After training and practicing activating and controlling the muscles the research team will then ask the participants to conduct the following tasks
1 Quiet standing not moving
2 Postural sway leaning forward and backward
3 Sitting down and standing up repeatedly
4 Squatting
5 Standing up on toes heel-raises
6 Walking on a treadmill at their preferred walking speed
Handrails both left and right will be always available to allow balance support if needed and additional harness protection is available
Individuals without amputation will conduct the functional tasks set once Individuals with amputation will be asked to do the functional task set both with their passive prosthesis and a powered prosthesis to determine if the powered device improves functional performance in addition to compare to individuals without amputation At times the research team will give them auditory feedback to help the participants time the motion and visual biosignal feedback to guide them on how the participants place the weight between legs
The research team expect the participants to come in for up to additional 10 sessions for these activities to account for adaptations in performance when using a powered prosthesis and post-training evaluations of their amputated and non-amputated muscles This estimate also accommodates necessary setup and take-down time that subjects must be present for while maintaining reasonable individual session periods
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