Prosthetic Performance Enhancement Trial

Not Applicable

Not yet recruiting

• Conditions: Amputation; Lower Limb Amputation at Hip (Injury); Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Knee; Lower Limb Amputation at Ankle (Injury)
• Interventions: Other: Flat terrain locomotor training; Other: Uneven terrain locomotor training

• Registration Number: NCT06419920
• Lead Sponsor: University of Nevada, Las Vegas

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.

Study Timeline

• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Study Start: 2025-01-02
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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
• willing to travel to the University of Nevada Las Vegas, Maryland Campus, for all training and assessment sessions

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flat terrain training	Flat terrain locomotor training	Walking on a standard, flat treadmill or mat.
Uneven terrain training	Uneven terrain locomotor training	Walking on an uneven terrain treadmill or mat.

Primary Outcome Measures

Name	Time	Method
Session adherence	Through study completion, over 4 weeks	Percentage of planned sessions attended, per participant.

Secondary Outcome Measures

Name	Time	Method
Beam walking distance	Pre-intervention, within 5 days post intervention	Distance traveled along a narrow beam, in m. Participants traverse a 3.66 m narrow beam. The distance traveled until the participant places a foot on the ground is measured. The mean of the final three of five trials is recorded.
Two-minute walk test distance	Pre-intervention, within 5 days post intervention	Walking distance traveled in two minutes, in m.
Average daily activity	Pre-intervention, within 5 days post intervention	Mean number of steps per day over 7 days, collected using ankle worn activity monitor.
Recruitment feasibility - sample characteristics	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.
Maximum relative step width variability during uneven terrain in comparison to overground walking	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.
L-test time	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.
Activities-specific Balance Confidence Scale summary score	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).
Recruitment feasibility - participating clinics	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.
Four Square Step Test time	Pre-intervention, within 5 days post intervention	Time to complete forwards, lateral and backwards stepping pattern, in s.
Protocol acceptability	End of intervention week 4	Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively.
Recruitment feasibility - recruitment rate	From start of recruitment period, to 12 month time point.	Number of participants recruited within one year
Activity data evaluation	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.
Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking	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.
Contour depth at maximum relative variability	Through study completion, over 4 weeks	Terrain contour depth at which the maximum relative variability was recorded, in m.

Trial Locations

Locations (1)

University of Nevada Las Vegas; 🇺🇸 Las Vegas, Nevada, United States