NCT05560061

An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nevada, Las Vegas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To attain high levels of mobility, people with lower limb amputation must build both the skill and the confidence to rely on their prosthesis in the environments that they will encounter in daily life. The purpose of this research is to determine whether practicing walking on an uneven terrain surface, specifically designed to present a modest, manageable disturbance to walking, can improve balance, locomotor flexibility (i.e. the ability to adapt walking to different walking contexts) and balance confidence, to a greater extent than walking on level ground alone. This preliminary study aims to determine whether uneven terrain walking is feasible and acceptable in the target population, and also to establish preliminary efficacy.

Detailed description

The long-term focus of this research is to investigate an uneven terrain training paradigm as an intervention to improve locomotor skill and confidence in lower limb prosthesis users; specifically to determine whether by inducing step-to-step variability in a safe environment, through training on an uneven terrain surface, individuals may develop more adaptable gait, and greater confidence in their mobility. We hypothesize that inducing a manageable level of variability into walking patterns during training will lead to greater balance, locomotor flexibility, and balance confidence. The surface has shallow contours that alter foot-ground interactions at each step, disrupting habitual movement patterns. The aim of this study is to establish feasibility, acceptability and preliminary efficacy of the uneven surface as a mobility training tool for lower limb prosthesis users. Ambulatory lower limb prosthesis users will attend a biomechanics laboratory on two occasions, during which they will complete walking practice sessions on a flat surface and on an uneven surface. A crossover design will be employed, with walking surface order randomized across participants. Preliminary efficacy will be established based on functional tasks and self-efficacy questions administered before and after the sessions on each day. Feasibility and acceptability will be established based on feasibility study objectives from Orsmond \& Cohn's feasibility framework.

Conditions

• Amputation

Interventions

Type	Name	Description
OTHER	Gait practice on an uneven terrain surface	Participants will walk back and forth on an uneven terrain surface wearing an overhead harness (with zero bodyweight support), at their self-selected comfortable speed.
OTHER	Gait practice on a flat terrain surface	Participants will walk back and forth on a level surface wearing an overhead harness (with zero bodyweight support), at their self-selected comfortable speed.

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-08-30
• Completion: 2025-12-31
• First posted: 2022-09-29
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States