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NCT Number: NCT06419920

Prosthetic Performance Enhancement 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location status: Recruiting

Location contact

Jenny A Kent, PhD, CSci

CONTACT

[email protected]

7028955949

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Flat terrain locomotor training

Other

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

Other

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.

Primary outcomes

  1. Session adherence

    Time frame: Through study completion, over 4 weeks

    Percentage of planned sessions attended, per participant.

Secondary outcomes

  1. L-test time

    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.

  2. Activities-specific Balance Confidence Scale summary score

    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).

  3. Average daily activity

    Time frame: Pre-intervention, within 5 days post intervention

    Mean number of steps per day over 7 days, collected using ankle worn activity monitor.

  4. Four Square Step Test time

    Time frame: Pre-intervention, within 5 days post intervention

    Time to complete forwards, lateral and backwards stepping pattern, in s.

  5. Single leg stand time

    Time frame: Pre-intervention, within 5 days post intervention

    Time standing on one leg up to a maximum of 20s, in s.

  6. Two-minute walk test distance

    Time frame: Pre-intervention, within 5 days post intervention

    Walking distance traveled in two minutes, in m.

  7. Protocol acceptability

    Time frame: End of intervention week 4

    Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively.

  8. Recruitment feasibility - recruitment rate

    Time frame: From start of recruitment period, to 12 month time point.

    Number of participants recruited within one year

  9. Recruitment feasibility - participating clinics

    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.

  10. Recruitment feasibility - sample characteristics

    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.

  11. Activity data evaluation

    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.

  12. Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking

    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.

  13. Contour depth at maximum relative variability

    Time frame: Through study completion, over 4 weeks

    Terrain contour depth at which the maximum relative variability was recorded, in m.

  14. Maximum relative step width variability during uneven terrain in comparison to overground walking

    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.

  15. Prosthesis Users Survey of Mobility t-score

    Time frame: Pre-intervention, within 5 days post intervention

    12-item self report tool measuring prosthesis users' mobility.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny A Kent, PhD, CSci

CONTACT

[email protected]

7028955949

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Collaborators

  • Chapman University
  • National Institutes of Health (NIH)
  • United States Department of Defense
  • University of Washington

Registry information

Acronym: PROSPER

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 17, 2024
Registry last updated
Jun 23, 2026

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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