- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05560061
An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jenny A Kent, PhD
- Phone Number: 702-895-5949
- Email: jenny.kent@unlv.edu
Study Contact Backup
- Name: Szu-Ping Lee, PT, PhD
- Phone Number: 702-895-3086
- Email: szu-ping.lee@unlv.edu
Study Locations
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Nevada
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Las Vegas, Nevada, United States, 89154
- Recruiting
- University of Nevada Las Vegas
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Contact:
- Jenny Kent, PhD
- Phone Number: 702-895-5949
- Email: jenny.kent@unlv.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Uneven terrain walking training
Participants will complete walking practice on an uneven terrain surface.
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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.
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ACTIVE_COMPARATOR: Flat terrain walking
Participants will complete walking practice on a level surface.
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Participants will walk back and forth on a level surface wearing an overhead harness (with zero bodyweight support), at their self-selected comfortable speed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in single limb stand time from baseline
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
|
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.
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Change in balance self-efficacy from baseline
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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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.
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in average walking speed
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
|
Comfortable walking speed during traverses of 30ft laboratory
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Change from baseline in narrow beam walking distance
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Distance travelled on a low level narrow beam without stepping off
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Change from baseline in horizontal ladder completion time
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Time to traverse a horizontal ladder with randomly separated rungs.
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Change from baseline in average step width during level walking
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Mean width of right and left steps during traverses of 30ft laboratory
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Change from baseline in average step length during level walking
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Mean length of right and left steps during traverses of 30ft laboratory
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Change from baseline in step width variability during level walking
Time Frame: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Standard deviation of right and left step widths during traverses of 30ft laboratory
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Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training protocol feasibility assessed by ability to complete 2-min bouts of walking on flat terrain
Time Frame: During training session on days 1 and 2 (each up to 45 minutes)
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Assessment of proposed duration of walking training bouts on flat terrain.
For each of six training bouts, successful completion of 2-min of walking without trial termination will be recorded (yes/no).
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During training session on days 1 and 2 (each up to 45 minutes)
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Training protocol feasibility assessed by ability to complete 2-min bouts of walking on uneven terrain
Time Frame: During training session on days 1 and 2 (each up to 45 minutes)
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Assessment of proposed duration of walking training bouts on uneven terrain.
For each of six training bouts, successful completion of 2-min of walking without trial termination will be recorded (yes/no).
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During training session on days 1 and 2 (each up to 45 minutes)
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Assessment protocol feasibility assessed by ability to take two steps or more on narrow beam
Time Frame: Immediately post- training sessions on days 1 and 2
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Assessment of feasibility of narrow beam-walking task.
Ability to take at least two steps on a narrow beam after training session (yes/no).
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Immediately post- training sessions on days 1 and 2
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Protocol acceptability assessed by session duration
Time Frame: During training session on days 1 and 2 (each up to 45 minutes)
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Duration of each session including testing and training in minutes.
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During training session on days 1 and 2 (each up to 45 minutes)
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Training protocol acceptability assessed by training acceptability questionnaire
Time Frame: Immediately after training on either day 1 or day 2
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Five item self-report Likert-style acceptability questionnaire, assessing the following components for uneven terrain training: 1) enjoyment, 2) challenge, 3) perceived safety, 4) tiredness after training, 5) desire to practice further
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Immediately after training on either day 1 or day 2
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenny A Kent, PhD, University of Nevada, Las Vegas
Publications and helpful links
General Publications
- 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.
- Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UNLV-2021-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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