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Substantial redesign of protocol and training warranted new study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uneven terrain walking training | Experimental | Participants will complete walking practice on an uneven terrain surface. |
|
| Flat terrain walking | Active Comparator | Participants will complete walking practice on a level surface. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average walking speed | Comfortable walking speed during traverses of 30ft laboratory | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Training protocol feasibility assessed by ability to complete 2-min bouts of walking on flat terrain | 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). | During training session on days 1 and 2 (each up to 45 minutes) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny A Kent, PhD | University of Nevada, Las Vegas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada Las Vegas | Las Vegas | Nevada | 89154 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26594739 | Background | 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. | |
| 14617445 | 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. |
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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.
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Outcomes assessor will be blinded to arm.
| 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. |
|
Distance travelled on a low level narrow beam without stepping off |
| 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. | 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 | 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 | 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 | Pre- and immediately post- training session on day 1 and pre- and immediately post- training session on day 2. |
| Training protocol feasibility assessed by ability to complete 2-min bouts of walking on uneven terrain | 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). | 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 | Assessment of feasibility of narrow beam-walking task. Ability to take at least two steps on a narrow beam after training session (yes/no). | Immediately post- training sessions on days 1 and 2 |
| Protocol acceptability assessed by session duration | Duration of each session including testing and training in minutes. | During training session on days 1 and 2 (each up to 45 minutes) |
| Training protocol acceptability assessed by training acceptability questionnaire | 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 | Immediately after training on either day 1 or day 2 |