An interventional study of Flat terrain locomotor training and Uneven terrain locomotor training in Amputation, Lower Limb Amputation Below Knee (Injury) and Lower Limb Amputation Above Knee (Injury), sponsored by University of Nevada, Las Vegas. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University of Nevada, Las Vegas · Not applicable, Interventional, and Other
The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.
Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users.
Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven.
The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 35 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Nevada, Las Vegas is the lead sponsor of 75 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Walking on a standard, flat treadmill or mat.
Other: Flat terrain locomotor training
Walking on an uneven terrain treadmill or mat.
Other: Uneven terrain locomotor training
The training will be comprised of up to 12 sets of 2-min continuous walking on a level treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.
The training will be comprised of up to 12 sets of 2-min continuous walking on an uneven terrain treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.
Session adherence
Percentage of planned sessions attended, per participant.
Time frame: Through study completion, over 4 weeks
L-test time
Time to complete L-test, in s. Participant rises from a chair and guided by cones, walks 10m forward, turns 90 degrees, walks a further 10m, turns 180 degrees, then follows the same path back to the chair and sits. Result from a single test following one practice trial is recorded.
Time frame: Pre-intervention, within 5 days post intervention
Activities-specific Balance Confidence Scale summary score
16-item self report measure recording confidence in performing activities during daily life that require balance, on numerical ratings scale, recorded as a percentage (out of 100).
Time frame: Pre-intervention, within 5 days post intervention
Average daily activity
Mean number of steps per day over 7 days, collected using ankle worn activity monitor.
Time frame: Pre-intervention, within 5 days post intervention
Four Square Step Test time
Time to complete forwards, lateral and backwards stepping pattern, in s.
Time frame: Pre-intervention, within 5 days post intervention
Single leg stand time
Time standing on one leg up to a maximum of 20s, in s.
Time frame: Pre-intervention, within 5 days post intervention
Two-minute walk test distance
Walking distance traveled in two minutes, in m.
Time frame: Pre-intervention, within 5 days post intervention
Protocol acceptability
Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively.
Time frame: End of intervention week 4
Recruitment feasibility - recruitment rate
Number of participants recruited within one year
Time frame: From start of recruitment period, to 12 month time point.
Recruitment feasibility - participating clinics
Number of clinics from which at least one participant is recruited.
Time frame: Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
Recruitment feasibility - sample characteristics
Sample characteristics of all participants enrolled in the study, regardless of completion.
Time frame: Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
Activity data evaluation
Completeness and quality of activity monitor data, measured as number of days with valid (non-erroneous) monitoring data.
Time frame: Throughout activity monitoring period, over 2 weeks
Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking
Medial-lateral trunk variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of peak per-step lateral trunk velocity during UT walking sessions relative to that of overground walking, in m/s.
Time frame: Through study completion, over 4 weeks
Contour depth at maximum relative variability
Terrain contour depth at which the maximum relative variability was recorded, in m.
Time frame: Through study completion, over 4 weeks
Maximum relative step width variability during uneven terrain in comparison to overground walking
Step width variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of step width during UT walking sessions relative to that of overground walking, in m.
Time frame: Through study completion, over 4 weeks
Prosthesis Users Survey of Mobility t-score
12-item self report tool measuring prosthesis users' mobility.
Time frame: Pre-intervention, within 5 days post intervention
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University of Nevada, Las Vegas