Restoration of Normative Postural Control

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNorth Carolina State University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • direct EMG controlled prosthetic ankle
  • PT guided prosthetic training

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

North Carolina State University

Lead sponsor

University of North Carolina, Chapel Hill

Collaborator