Restoration of Normative Postural Control

Part of paid clinical trials in Raleigh, North Carolina.

Sponsor
North Carolina State University
Study ID
NCT06452186
Status
Recruiting
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Conditions

  • Lower Limb Amputation Below Knee (Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • direct EMG controlled prosthetic ankle — DEVICE
    Patients are trained to use the powered prosthetic ankles
  • PT guided prosthetic training — BEHAVIORAL
    Amputees are trained to use prosthetic ankles

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Apr 2026
Primary completion
Jul 1, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: dEMG group
    Patients go through the training procedure with the direct EMG controlled powered prosthetic ankle.
  • Active Comparator: Passive group
    Patients go through the training procedure with their own passive prosthetic ankles

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
North Carolina State UniversityRaleighNorth Carolina27695
He Huang, PhD
[email protected]
919-515-5218
Laura Rohrbaugh
[email protected]
919-513-3840

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By research site
North Carolina State University· Raleigh, NC

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