Thinking of joining a study?

Register your interest

NCT05560061 | Recruiting | Amputation


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

University of Nevada, Las Vegas

Information provided by (Responsible Party):

Jenny Kent

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.

Condition or disease

Amputation

Intervention/treatment

Gait practice on an uneven terrain surface

Gait practice on a flat terrain surface

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 10 participants
Masking : Single
Masking Description : Outcomes assessor will be blinded to arm.
Primary Purpose : Treatment
Official Title : An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : December 31, 2023
Arm Intervention/treatment

Experimental: Uneven terrain walking training

Participants will complete walking practice on an uneven terrain surface.

Other: Gait practice on an uneven terrain surface

Active Comparator: Flat terrain walking

Participants will complete walking practice on a level surface.

Other: Gait practice on a flat terrain surface

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Nevada

University of Nevada Las Vegas

Las Vegas, Nevada, United States, 89154

Loading...