Lower Limb Amputation Below Knee (Injury)NCT06452186
Restoration of Normative Postural Control
A study testing PT guided prosthetic training in people with Lower Limb Amputation Below Knee (Injury), run by North Carolina State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- PT guided prosthetic training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older;
- unilateral bower limb amputee
- K-level 2 or higher (who are frequent prosthesis users and may benefit from the proposed prosthesis training and use of dEMG controlled powered prosthesis)
- Amputation occurred over 2 years ago
- At least 1 year of experience using their prosthetic leg
- Has used the current socket for at least 6 months without a significant skin issue or major modification
- Are willing to come to NC State University's Centennial Campus to participate in research and be photographed while doing research activities
Who cannot join
- Have a very short residual shank (the length of the residual limb is ≤15% of the length of intact limb)
- Cannot perform functional ambulation in the community on a daily basis without assistive devices
- Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
- Congenital amputees
- Amputees who use powered prosthetic ankles
- Weight more than 300lbs
- Pregnant Person
- Allergic to latex, which is often contained in medical tapes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Carolina State University
Raleigh, North Carolina, 27695
He Huang, PhD, 919-515-5218, hhuang11@ncsu.edu
Laura Rohrbaugh, 919-513-3840, lasmith6@ncsu.edu
About this study
Official title: Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles
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:
Read more
- whether dEMG control will improve balance and postural stability of amputees,
- 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.
Read the 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- Being tested
- direct EMG controlled prosthetic ankle, PT guided prosthetic training
- Keywords
- powered ankle prosthesis, direct EMG control, balance, cognitive load, muscle synergy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct EMG controlled prosthetic ankleDevice
Patients are trained to use the powered prosthetic ankles
PT guided prosthetic trainingBehavioural
Amputees are trained to use prosthetic ankles
| Study group | Role | What they receive |
|---|---|---|
| dEMG group | Experimental | Patients go through the training procedure with the direct EMG controlled powered prosthetic ankle. Receives: Device: direct EMG controlled prosthetic ankle; Behavioral: PT guided prosthetic training |
| Passive group | Active comparator | Patients go through the training procedure with their own passive prosthetic ankles Receives: Behavioral: PT guided prosthetic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices
Secondary outcomes (6)
Frequency of stepping responses
Number of amputees to conduct steps to recover from disturbance divided by total number of disturbance, which they experienced.
Measured: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Oct 2023
- Primary completion30 May 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups amputees go through the same training procedure with different prostheses. Their functionality will be compared before and the after the training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, He Huang, North Carolina State University
- Investigators
- He Huang, PhD, Principal investigator, NC State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452186
- Sponsor's protocol ID
- 26076
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles
- ClinicalTrials.gov ID
- NCT06452186
- Acronym / sponsor ID
- 26076
- Keywords
- powered ankle prosthesis, direct EMG control, balance, cognitive load, muscle synergy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- whether dEMG control will improve balance and postural stability of amputees,
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups amputees go through the same training procedure with different prostheses. Their functionality will be compared before and the after the training.
| Arm | Type | Receives |
|---|---|---|
| dEMG group | Experimental | Device: direct EMG controlled prosthetic ankle, Behavioral: PT guided prosthetic trainingPatients go through the training procedure with the direct EMG controlled powered prosthetic ankle. |
| Passive group | Active comparator | Behavioral: PT guided prosthetic trainingPatients go through the training procedure with their own passive prosthetic ankles |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older;
- unilateral bower limb amputee
- K-level 2 or higher (who are frequent prosthesis users and may benefit from the proposed prosthesis training and use of dEMG controlled powered prosthesis)
- Amputation occurred over 2 years ago
- At least 1 year of experience using their prosthetic leg
Key exclusion criteria (8 listed)
- Have a very short residual shank (the length of the residual limb is ≤15% of the length of intact limb)
- Cannot perform functional ambulation in the community on a daily basis without assistive devices
- Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
- Congenital amputees
- Amputees who use powered prosthetic ankles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct EMG controlled prosthetic anklePatients are trained to use the powered prosthetic ankles | Device | dEMG group |
| PT guided prosthetic trainingAmputees are trained to use prosthetic ankles | Behavioural | Passive group, dEMG group |
Primary outcome
aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced
Time frame: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices
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.
6 secondary outcomes
Frequency of stepping responses
Time frame: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices
Zero-time-lag cross correlation coefficients for bilateral ankle torque
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 )
Time frame: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
He Huang, PhD principal investigator
NC State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PT guided prosthetic training in people with Lower Limb Amputation Below Knee (Injury), run by North Carolina State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neuromuscular Rehabilitation Engineering Laboratory (919-513-3840, nrel.ncsu.contact@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced (time frame: Pre-training (before the training starts), Post-training (immediately after the training), and follow-up evaluation (one month) with both passive and dEMG devices). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.