Prosthetic Performance Enhancement Trial (PROSPER)

Nevada System of Higher Education (NSHE)

Status: Enrolling

Conditions: Lower Limb Amputation Knee; Amputation; Lower Limb Amputation at Ankle (Injury); Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation at Hip (Injury); Lower Limb Amputation Above Knee (Injury)

Treatments: Other: Flat terrain locomotor training; Other: Uneven terrain locomotor training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT06419920

CDMRP-OP230011 (Other Grant/Funding Number)

UNLV-2023-595

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Flat terrain training

Active Comparator group

Description:

Walking on a standard, flat treadmill or mat.

Treatment:

Other: Flat terrain locomotor training

Uneven terrain training

Experimental group

Description:

Walking on an uneven terrain treadmill or mat.

Treatment:

Other: Uneven terrain locomotor training