AmputationNCT05560061
An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation
A study testing Gait practice on an uneven terrain surface and Gait practice on a flat terrain surface in people with Amputation, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Gait practice on an uneven terrain surface and Gait practice on a flat terrain surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
About this study
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.
Read the 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
- Being tested
- Gait practice on an uneven terrain surface, Gait practice on a flat terrain surface
- Keywords
- locomotion, gait, rehabilitation, motor learning, lower limb amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait practice on an uneven terrain surfaceOther
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.
Gait practice on a flat terrain surfaceOther
Participants will walk back and forth on a level surface wearing an overhead harness (with zero bodyweight support), at their self-selected comfortable speed.
| Study group | Role | What they receive |
|---|---|---|
| Uneven terrain walking training | Experimental | Participants will complete walking practice on an uneven terrain surface. Receives: Other: Gait practice on an uneven terrain surface |
| Flat terrain walking | Active comparator | Participants will complete walking practice on a level surface. Receives: Other: Gait practice on a flat terrain surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Comfortable walking speed during traverses of 30ft laboratory
Measured: 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
Distance travelled on a low level narrow beam without stepping off
Measured: 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
Time to traverse a horizontal ladder with randomly separated rungs.
Measured: 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
Mean width of right and left steps during traverses of 30ft laboratory
Measured: 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
Mean length of right and left steps during traverses of 30ft laboratory
Measured: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
Change from baseline in step width variability during level walking
Standard deviation of right and left step widths during traverses of 30ft laboratory
Measured: Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jul 2022
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Substantial redesign of protocol and training warranted new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Kent, University of Nevada, Las Vegas
- Investigators
- Jenny A Kent, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560061
- Sponsor's protocol ID
- UNLV-2021-52
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26594739Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.
PubMed 14617445
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation
- ClinicalTrials.gov ID
- NCT05560061
- Acronym / sponsor ID
- UNLV-2021-52
- Conditions
- Amputation
- Keywords
- locomotion, gait, rehabilitation, motor learning, lower limb amputation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Substantial redesign of protocol and training warranted new study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Uneven terrain walking training | Experimental | Other: Gait practice on an uneven terrain surfaceParticipants will complete walking practice on an uneven terrain surface. |
| Flat terrain walking | Active comparator | Other: Gait practice on a flat terrain surfaceParticipants will complete walking practice on a level surface. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait practice on an uneven terrain surfaceParticipants will walk back and forth on an uneven terrain surface wearing an overhead harness (with zero bodyweight support), at their self-selected comfortable speed. | Other | Uneven terrain walking training |
| Gait practice on a flat terrain surfaceParticipants will walk back and forth on a level surface wearing an overhead harness (with zero bodyweight support), at their self-selected comfortable speed. | Other | Flat terrain walking |
Primary outcome
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.
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.
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 26594739Orsmond 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.
- Background: PubMed 14617445Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny A Kent, PhD principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait practice on an uneven terrain surface and Gait practice on a flat terrain surface in people with Amputation, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560061, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.