University of Nevada Las Vegas
Las Vegas, Nevada, 89154, United States
Location status: Recruiting
NCT Number: NCT06419920
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Las Vegas, Nevada, 89154, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through study completion, over 4 weeks
Percentage of planned sessions attended, per participant.
Time frame: Pre-intervention, within 5 days post intervention
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
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
Mean number of steps per day over 7 days, collected using ankle worn activity monitor.
Time frame: Pre-intervention, within 5 days post intervention
Time to complete forwards, lateral and backwards stepping pattern, in s.
Time frame: Pre-intervention, within 5 days post intervention
Time standing on one leg up to a maximum of 20s, in s.
Time frame: Pre-intervention, within 5 days post intervention
Walking distance traveled in two minutes, in m.
Time frame: End of intervention week 4
Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively.
Time frame: From start of recruitment period, to 12 month time point.
Number of participants recruited within one year
Time frame: Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
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.
Sample characteristics of all participants enrolled in the study, regardless of completion.
Time frame: Throughout activity monitoring period, over 2 weeks
Completeness and quality of activity monitor data, measured as number of days with valid (non-erroneous) monitoring data.
Time frame: Through study completion, over 4 weeks
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
Terrain contour depth at which the maximum relative variability was recorded, in m.
Time frame: Through study completion, over 4 weeks
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: Pre-intervention, within 5 days post intervention
12-item self report tool measuring prosthesis users' mobility.
Contact information is provided by the study sponsor or research team.
University of Nevada, Las Vegas
Other
Acronym: PROSPER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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