Clinical trial NCT06419920: Prosthetic Performance Enhancement Trial
Official title: Prosthetic Performance Enhancement Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Chapman University
name: United States Department of Defense
name: National Institutes of Health (NIH)
First posted: 2024-05-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Session adherence
timeFrame: Through study completion, over 4 weeks
Secondary outcomes:
measure: L-test time
timeFrame: Pre-intervention, within 5 days post intervention
measure: Activities-specific Balance Confidence Scale summary score
timeFrame: Pre-intervention, within 5 days post intervention
measure: Average daily activity
timeFrame: Pre-intervention, within 5 days post intervention
measure: Four Square Step Test time
timeFrame: Pre-intervention, within 5 days post intervention
measure: Single leg stand time
timeFrame: Pre-intervention, within 5 days post intervention
measure: Two-minute walk test distance
timeFrame: Pre-intervention, within 5 days post intervention
measure: Protocol acceptability
timeFrame: End of intervention week 4
measure: Recruitment feasibility - recruitment rate
timeFrame: From start of recruitment period, to 12 month time point.
measure: Recruitment feasibility - participating clinics
timeFrame: Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
measure: Recruitment feasibility - sample characteristics
timeFrame: Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
measure: Activity data evaluation
timeFrame: Throughout activity monitoring period, over 2 weeks
measure: Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking
timeFrame: Through study completion, over 4 weeks
measure: Contour depth at maximum relative variability
timeFrame: Through study completion, over 4 weeks
measure: Maximum relative step width variability during uneven terrain in comparison to overground walking
timeFrame: Through study completion, over 4 weeks
measure: Prosthesis Users Survey of Mobility t-score
timeFrame: Pre-intervention, within 5 days post intervention
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Jenny A Kent, PhD, CSci
role: PRINCIPAL_INVESTIGATOR
References: