About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
lower limb amputation at ankle (Symes) level and above
age 18+ years
fitted with a walking prosthesis and use it regularly for home and/or community ambulation
good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
Disqualifiers
leg/foot ulcer or other conditions that cause pain during weight-bearing
poor skin integrity that could cause tissue breakdown by walking
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 that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
Trial design
Parallel
Treatments tested in this trial
Flat terrain locomotor training
Other interventionThe 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.
Uneven terrain locomotor training
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Session adherence
Percentage of planned sessions attended, per participant.
Secondary outcomes
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.
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).
Average daily activity
Mean number of steps per day over 7 days, collected using ankle worn activity monitor.
Four Square Step Test time
Time to complete forwards, lateral and backwards stepping pattern, in s.
Sponsors and contacts
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University of Nevada, Las Vegas
Lead sponsor
University of Washington
Collaborator
Chapman University
Collaborator
United States Department of Defense
Collaborator
National Institutes of Health (NIH)
Collaborator