AmputationPROSPERNCT06419920
Prosthetic Performance Enhancement Trial
A study testing Flat terrain locomotor training and Uneven terrain locomotor training in people with Amputation and Lower Limb Amputation Below Knee (Injury), run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
- What is being tested?
- Flat terrain locomotor training and Uneven terrain locomotor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2025to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- able to walk for three minutes at a time with or without an assistive device
Who cannot join
- 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.
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
Jenny A Kent, PhD, CSci, 7028955949, jenny.kent@unlv.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Amputation, Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation at Ankle (Injury), Lower Limb Amputation Knee, Lower Limb Amputation at Hip (Injury)
- Being tested
- Flat terrain locomotor training, Uneven terrain locomotor training
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flat terrain locomotor trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Flat terrain training | Active comparator | Walking on a standard, flat treadmill or mat. Receives: Other: Flat terrain locomotor training |
| Uneven terrain training | Experimental | Walking on an uneven terrain treadmill or mat. Receives: Other: Uneven terrain locomotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session adherence
Percentage of planned sessions attended, per participant.
Measured: Through study completion, over 4 weeks
Secondary outcomes (15)
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.
Measured: 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).
Measured: 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.
Measured: Pre-intervention, within 5 days post intervention
Four Square Step Test time
Time to complete forwards, lateral and backwards stepping pattern, in s.
Measured: Pre-intervention, within 5 days post intervention
Single leg stand time
Time standing on one leg up to a maximum of 20s, in s.
Measured: Pre-intervention, within 5 days post intervention
Two-minute walk test distance
Walking distance traveled in two minutes, in m.
Measured: 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.
Measured: End of intervention week 4
Recruitment feasibility - recruitment rate
Number of participants recruited within one year
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, over 4 weeks
Prosthesis Users Survey of Mobility t-score
12-item self report tool measuring prosthesis users' mobility.
Measured: Pre-intervention, within 5 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start26 Jun 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility study incorporating a single-blinded Phase I clinical trial with a parallel groups design, involving two treatment conditions: uneven terrain training (UT) and flat terrain (FT) training. Participants will be allocated randomly to UT and FT arms in a 6:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Chapman University, United States Department of Defense, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jenny A Kent, PhD, CSci, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419920
- Sponsor's protocol ID
- UNLV-2023-595
- Other IDs
- CDMRP-OP230011
- Acronym
- PROSPER
- Status last verified
- Dec 2025
- First submitted
- 2 May 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No