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New treatment option for Lower Limb Amputation Below Knee (Injury)
Official title Restoration of Normative Postural Control
ClinicalTrials.gov ID: NCT06452186
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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...
- Amputation occurred over 2 years ago
- At least 1 year of experience using their prosthetic leg
You likely can't join if
- 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...
- Congenital amputees
- Amputees who use powered prosthetic ankles
- Weight more than 300lbs
See the full eligibility criteria
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Raleigh, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Raleigh, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.