NCT06419920

Prosthetic Performance Enhancement Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Nevada, Las Vegas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users. Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven. The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.

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)

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2025-06-26
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-05-17
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States