Prosthetic Performance Enhancement Trial

NCT06419920 | Recruiting

• 2 other identifiers: UNLV-2023-595CDMRP-OP230011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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; Lower Limb Amputation at Hip (Injury)

Outcome Measures

Primary Outcomes (1)

• Session adherence

  Percentage of planned sessions attended, per participant.

  Through study completion, over 4 weeks

Secondary Outcomes (15)

• L-test time

  Pre-intervention, within 5 days post intervention

• Activities-specific Balance Confidence Scale summary score

  Pre-intervention, within 5 days post intervention

• Average daily activity

  Pre-intervention, within 5 days post intervention

• Four Square Step Test time

  Pre-intervention, within 5 days post intervention

• Single leg stand time

  Pre-intervention, within 5 days post intervention

Study Arms (2)

Flat terrain training

ACTIVE COMPARATOR

Walking on a standard, flat treadmill or mat.

Other: Flat terrain locomotor training

Uneven terrain training

EXPERIMENTAL

Walking on an uneven terrain treadmill or mat.

Other: Uneven terrain locomotor training

Interventions

Flat terrain locomotor training OTHER

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.

Flat terrain training

Uneven terrain locomotor training OTHER

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.

Uneven terrain training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: collaborator
• Chapman University: collaborator
• National Institutes of Health (NIH): collaborator
• University of Nevada, Las Vegas: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jenny A Kent, PhD, CSci

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny A Kent, PhD, CSci

CONTACT

7028955949; jenny.kent@unlv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study incorporating a single-blinded Phase I clinical trial with a parallel groups design, involving two treatment conditions: uneven terrain training (UT) and flat terrain (FT) training. Participants will be allocated randomly to UT and FT arms in a 6:1 ratio.

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 17, 2024
• Study Start: June 26, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)