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

NCT05560061 | Withdrawn

• 1 other identifier: UNLV-2021-52
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in single limb stand time from baseline

  The duration the participant is able to stand on one limb without touching the floor with the raised foot, out of a maximum of 30 seconds.

  Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.

• Change in balance self-efficacy from baseline

  Participants will rate on a scale of 0 (not confident at all) to 10 (extremely confident) their confidence in their ability to walk specified distances on the narrow beam.

  Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.

Secondary Outcomes (6)

• Change from baseline in average walking speed

  Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.

• Change from baseline in narrow beam walking distance

  Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.

• Change from baseline in horizontal ladder completion time

  Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.

• Change from baseline in average step width during level walking

  Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.

• Change from baseline in average step length during level walking

  Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.

Other Outcomes (5)

• Training protocol feasibility assessed by ability to complete 2-min bouts of walking on flat terrain

  During training session on days 1 and 2 (each up to 45 minutes)

• Training protocol feasibility assessed by ability to complete 2-min bouts of walking on uneven terrain

  During training session on days 1 and 2 (each up to 45 minutes)

• Assessment protocol feasibility assessed by ability to take two steps or more on narrow beam

  Immediately post- training sessions on days 1 and 2

Study Arms (2)

Uneven terrain walking training

EXPERIMENTAL

Participants will complete walking practice on an uneven terrain surface.

Other: Gait practice on an uneven terrain surface

Flat terrain walking

ACTIVE COMPARATOR

Participants will complete walking practice on a level surface.

Other: Gait practice on a flat terrain surface

Interventions

Gait practice on an uneven terrain surface 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.

Uneven terrain walking training

Gait practice on a flat terrain surface 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.

Flat terrain walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Publications (2)

• 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.

  PMID: 26594739 BACKGROUND

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

  PMID: 14617445 BACKGROUND

Study Officials

• Jenny A Kent, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 29, 2022
• Study Start: July 1, 2022
• Primary Completion: August 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)