Clinical trial NCT05560061: An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation
Official title: An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amputation
Keywords: locomotion
gait
rehabilitation
motor learning
lower limb amputation
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized into two groups - 1) uneven - flat; 2) flat - uneven. Uneven and flat sessions will occur on separate days, 12-72 hours apart.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* lower limb amputation at ankle level or above
* properly fitted with a walking prosthesis, used regularly for home and/or community ambulation
* good socket fit assessed by a score of 7-10 on the socket fit comfort score (Hanspal et at., 2003).
* able to walk for two minutes at a time with or without an assistive device
* willing to travel to the test site two times for training and testing.

Exclusion Criteria:

* leg/foot ulcer/sore or other conditions that cause pain during weight-bearing
* 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
* diagnosis of cognitive disturbances
* allergy to medical adhesives
* women who are pregnant or think they may be pregnant
* acute illness
* dizziness on the day of testing

Primary outcomes:
measure: Change in single limb stand time from baseline
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
measure: Change in balance self-efficacy from baseline
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
Secondary outcomes:
measure: Change from baseline in average walking speed
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
measure: Change from baseline in narrow beam walking distance
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
measure: Change from baseline in horizontal ladder completion time
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
measure: Change from baseline in average step width during level walking
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
measure: Change from baseline in average step length during level walking
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
measure: Change from baseline in step width variability during level walking
timeFrame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
Other outcomes:
measure: Training protocol feasibility assessed by ability to complete 2-min bouts of walking on flat terrain
timeFrame: During training session on days 1 and 2 (each up to 45 minutes)
measure: Training protocol feasibility assessed by ability to complete 2-min bouts of walking on uneven terrain
timeFrame: During training session on days 1 and 2 (each up to 45 minutes)
measure: Assessment protocol feasibility assessed by ability to take two steps or more on narrow beam
timeFrame: Immediately post- training sessions on days 1 and 2
measure: Protocol acceptability assessed by session duration
timeFrame: During training session on days 1 and 2 (each up to 45 minutes)
measure: Training protocol acceptability assessed by training acceptability questionnaire
timeFrame: Immediately after training on either day 1 or day 2
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Jenny A Kent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. doi: 10.1177/1539449215578649.
citation: Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.