Recruiting

Observational Study

Sponsor:

North Carolina State University

Code:

NCT06182202

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Powered Prosthesis

Study Details

Brief summary:

Lower limb amputees rely on their prosthetic to remain active and lead an independent life. In recent years, measuring residual muscle activity has been used to interpret a user's intent and thereby modulate prosthesis control. However, little knowledge is held on how residual muscle activity differs from non-amputated muscle. The research team will analyze and compare neuromuscular physiology in non-amputee individuals and amputees' non-amputated and residual muscles across functional tasks to better understand how amputees control their muscles. Such information will inform design of modern prosthesis controllers.

Conditions

Amputation

Study ID

NCT06182202

Start date

Jun 17, 2022

Status verified date

Dec, 2023

Completion date

May 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria for Individuals without Amputation:

  • Live in the United States
  • Are 18 years of age or older
  • Can walk across low-level environmental barriers such as curbs, stairs, or uneven surfaces unassisted and without much difficulty

Exclusion Criteria for Individuals without Amputation:

- Have any cognitive, visual, or balance impairments that affects your ability to provide informed consent or to follow instructions during the experiments

  • Have had a stroke
  • Have heart disease
  • Weigh 450 pounds or more (for harness safety)
  • Have a girth/waist circumference more than 49 inches (124.4 cm) (for harness safety)
  • Have allergies to adhesives

Inclusion Criteria for Individuals with Amputation:

  • Live in the United States
  • Are a unilateral lower-limb amputee
  • Have lower limb length from the knee to where the amputation occurred at least 10cm long
  • Can walk across low-level environmental barriers such as curbs, stairs, or uneven surfaces unassisted and without much difficulty

Exclusion Criteria for Individuals with Amputation:

- Have any cognitive, visual, or balance impairments that affects your ability to provide consent or to follow instructions during the experiments

  • Have had a stroke
  • Have heart disease
  • Had skin lesions/incomplete healing following amputation
  • Have ulcers
  • Have lower limb length from the knee to where the amputation occurred less than 10cm long
  • Weigh 450 pounds or more (for harness safety)
  • Have a girth/waist circumference more than 49 inches (124.4 cm) (for harness safety)
  • Have allergies to adhesives

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Individuals Without Amputation

No Intervention Tested in identical tasks for comparison to Individuals with Amputation

experimental: Individuals With Amputation

Tasks with a passive prosthesis Tasks with a powered active prosthesis

Interventions

Powered Prosthesis

Custom in-house powered prosthetic device (used in prior studies, see Citations).

Primary outcome measure

  • Motor Unit Action Potential Amplitudes [ Time Frame: Through study completion (an average of 36 months). ]
  • Motor Unit Coherence [ Time Frame: Through study completion (an average of 36 months). ]

Central Contacts and Locations

Central contacts

Ming Liu, PhD

919-515-8541mliu10@ncsu.edu

Noah Rubin, BA

nrubin@ncsu.edu

Locations

North Carolina State University

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

He Huang, PhD

919-515-5218hhuang11@ncsu.edu

Laura Rohrbaugh

919-513-3840lasmith6@ncsu.edu

More Information

Sponsor

North Carolina State University

Last update posted

Dec 26, 2023

Last verified

Dec, 2023

Keywords

  • Amputees
  • Electromyography
  • Ultrasound
  • Neuromuscular Physiology
  • Prostheses
  • Muscle Activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2023-12-26.