Uneven terrain walking training for Amputation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
AmputationGait practice on an uneven terrain surface - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: During training session on days 1 and 2 (each up to 45 minutes)

Day 1
Protocol acceptability assessed by session duration
Training protocol feasibility assessed by ability to complete 2-min bouts of walking on flat terrain
Training protocol feasibility assessed by ability to complete 2-min bouts of walking on uneven terrain
Day 2
Training protocol acceptability assessed by training acceptability questionnaire
Day 1
Assessment protocol feasibility assessed by ability to take two steps or more on narrow beam
Day 2
Change from baseline in average step length during level walking
Change from baseline in average step width during level walking
Change from baseline in average walking speed
Change from baseline in horizontal ladder completion time
Change from baseline in narrow beam walking distance
Change from baseline in step width variability during level walking
Change in balance self-efficacy from baseline
Limb structure

Trial Safety

Trial Design

2 Treatment Groups

Flat terrain walking
1 of 2
Uneven terrain walking training
1 of 2

Active Control

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Uneven terrain walking training · No Placebo Group · N/A

Uneven terrain walking training
Other
Experimental Group · 1 Intervention: Gait practice on an uneven terrain surface · Intervention Types: Other
Flat terrain walking
Other
ActiveComparator Group · 1 Intervention: Gait practice on a flat terrain surface · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during training session on days 1 and 2 (each up to 45 minutes)

Who is running the clinical trial?

University of Nevada, Las VegasLead Sponsor
53 Previous Clinical Trials
11,031 Total Patients Enrolled
Jenny A Kent, PhDPrincipal InvestigatorUniversity of Nevada, Las Vegas

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to walk with a prosthesis that is properly fitted and used regularly for home and/or community ambulation.
You are able to walk for two minutes at a time with or without an assistive device.
You are willing to travel to the test site two times for training and testing.