Recruiting

Prosthetic Performance

Sponsor:

University of Nevada, Las Vegas

Code:

NCT06419920

Conditions

Amputation

Lower Limb Amputation Below Knee (Injury)

Lower Limb Amputation Above Knee (Injury)

Lower Limb Amputation at Ankle (Injury)

Lower Limb Amputation Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Flat terrain locomotor training

Uneven terrain locomotor training

Study Details

Brief summary:

The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.

Conditions

Amputation

Lower Limb Amputation Below Knee (Injury)

Lower Limb Amputation Above Knee (Injury)

Lower Limb Amputation at Ankle (Injury)

Lower Limb Amputation Knee

Study ID

NCT06419920

Start date

Jun 26, 2025

Status verified date

Dec, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • lower limb amputation at ankle (Symes) level and above
  • age 18+ years
  • fitted with a walking prosthesis and use it regularly for home and/or community ambulation
  • good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
  • able to walk for three minutes at a time with or without an assistive device

Exclusion Criteria:

  • leg/foot ulcer or other conditions that cause pain during weight-bearing
  • poor skin integrity that could cause tissue breakdown by walking
  • cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
  • unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
  • pregnancy

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Flat terrain training

Walking on a standard, flat treadmill or mat.

experimental: Uneven terrain training

Walking on an uneven terrain treadmill or mat.

Interventions

Flat terrain locomotor training

The training will be comprised of up to 12 sets of 2-min continuous walking on a level treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.

Uneven terrain locomotor training

The training will be comprised of up to 12 sets of 2-min continuous walking on an uneven terrain treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.

Primary outcome measure

  • Session adherence [ Time Frame: Through study completion, over 4 weeks ]

Central Contacts and Locations

Central contacts

Jenny A Kent, PhD, CSci

7028955949jenny.kent@unlv.edu

Locations

University of Nevada Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89154

Contacts

Jenny A Kent, PhD, CSci

7028955949jenny.kent@unlv.edu

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Jun 23, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Nevada, Las Vegas on 2026-06-23.