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

NCT ID: NCT05560061

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Amputation

Keywords

locomotion; gait; rehabilitation; motor learning; lower limb amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Uneven terrain walking training

Participants will complete walking practice on an uneven terrain surface.

Group Type: EXPERIMENTAL

Gait practice on an uneven terrain surface

Intervention Type: OTHER

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.

Flat terrain walking

Participants will complete walking practice on a level surface.

Group Type: ACTIVE_COMPARATOR

Gait practice on a flat terrain surface

Intervention Type: OTHER

Participants will walk back and forth on a level surface wearing an overhead harness (with zero bodyweight support), at their self-selected comfortable speed.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Jenny Kent

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny A Kent, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Las Vegas

Locations

University of Nevada Las Vegas

Las Vegas, Nevada, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26594739 (View on PubMed)

Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.

Reference Type: BACKGROUND

PMID: 14617445 (View on PubMed)

Other Identifiers

UNLV-2021-52

Identifier Type: -

Identifier Source: org_study_id