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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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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:
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dEMG group | Experimental | Patients go through the training procedure with the direct EMG controlled powered prosthetic ankle. |
|
| Passive group | Active Comparator | Patients go through the training procedure with their own passive prosthetic ankles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| direct EMG controlled prosthetic ankle | Device | Patients are trained to use the powered prosthetic ankles |
|
| Measure | Description | Time Frame |
|---|---|---|
| aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced | This measurement is to quantify the movement of the COM at the time when the disturbance is introduced and represents an important element of the capability of the participants to conduct anticipatory. Higher value indicates better capacity to conduct anticipatory postural control. | Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of stepping responses | Number of amputees to conduct steps to recover from disturbance divided by total number of disturbance, which they experienced. | Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neuromuscular Rehabilitation Engineering Laboratory | Contact | 919-513-3840 | nrel.ncsu.contact@gmail.com | |
| Ming Liu, PhD | Contact | 919-515-8543 | mliu10@ncsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| He Huang, PhD | NC State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina State University | Recruiting | Raleigh | North Carolina | 27695 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2024 | Jun 4, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2024 | Jun 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Two groups amputees go through the same training procedure with different prostheses. Their functionality will be compared before and the after the training.
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The PT, who evaluates the participants, is blinded for their previous training experience.
| PT guided prosthetic training | Behavioral | Amputees are trained to use prosthetic ankles |
|
| Zero-time-lag cross correlation coefficients for bilateral ankle torque |
Torque in the anterior-posterior direction. This outcome quantify the symmetry between the prosthetic ankle and the unaffected ankle when the participants try to maintain balance under expected disturbance |
| Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices |
| Prosthesis Embodiment Scale | The Prosthesis Embodiment Scale for Lower Limb Amputees (PEmbS-LLA) measures amputees' feeling of ownership, sense of agency, and anatomical plausibility of a lower limb prosthetic device. This scale has been tested on lower limb amputees using daily prescribed prosthesis (not neurally controlled) with established validity and reliability. The score range is -3~3 and high value indicates better embodiment. | Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices |
| Average muscle modules structure correlation | Correlation coefficient of muscle modules structures identified using nonnegative matrix factorization (NNMF) during a voluntary postural sway task. This measure is used to determine whether muscle modules employed between populations are meaningfully similar. | Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices |
| Scores from Amputee Mobility Predictor (AMP) Test | Clinical balance outcomes used to measure the capacity of participants to conduct functional tasks, which are related to balance. The score ranges from 0-47. Higher values indicate better performance. | Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices |
| Scores from MiniBES Test (Balance Evaluation Systems Test ) | Clinical balance outcomes used to measure the capacity of participants to conduct functional tasks, which are related to balance. The score ranges from 0 to 28. The higher value indicates better balance capability | Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices |