Prosthetic Performance Enhancement Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nevada, Las Vegas

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Flat terrain locomotor training

    Other intervention

    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 intervention

    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.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Flat terrain trainingActive comparator 1 intervention
Group B: Uneven terrain trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Session adherence

Percentage of planned sessions attended, per participant.

Time frame
Through study completion, over 4 weeks

Secondary outcomes

1

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.

Time frame
Pre-intervention, within 5 days post intervention
2

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).

Time frame
Pre-intervention, within 5 days post intervention
3

Average daily activity

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

Time frame
Pre-intervention, within 5 days post intervention
4

Four Square Step Test time

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

Time frame
Pre-intervention, within 5 days post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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