Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2025-06-26
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Flat terrain training
Walking on a standard, flat treadmill or mat.
Flat 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.
Uneven terrain training
Walking on an uneven terrain treadmill or mat.
Uneven terrain locomotor training
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.
Interventions
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Flat 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.
Uneven terrain locomotor training
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* able to walk for three minutes at a time with or without an assistive device
Exclusion Criteria
* 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.
* pregnancy
18 Years
ALL
No
Sponsors
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University of Washington
OTHER
Chapman University
OTHER
United States Department of Defense
FED
National Institutes of Health (NIH)
NIH
University of Nevada, Las Vegas
OTHER
Responsible Party
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Principal Investigators
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Jenny A Kent, PhD, CSci
Role: PRINCIPAL_INVESTIGATOR
University of Nevada, Las Vegas
Locations
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University of Nevada Las Vegas
Las Vegas, Nevada, United States
Countries
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Central Contacts
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Facility Contacts
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Jenny A Kent, PhD, CSci
Role: primary
Other Identifiers
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CDMRP-OP230011
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UNLV-2023-595
Identifier Type: -
Identifier Source: org_study_id