Terrain Locomotor Training for Amputation

(PROSPER Trial)

Overseen By Jenny A Kent, PhD, CSci

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Leg/foot ulcer, Poor skin integrity, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new walking program for people with lower limb prostheses. The program emphasizes walking over uneven surfaces to enhance walking skills and boost confidence. Participants will walk on either flat terrain (flat terrain locomotor training) or uneven terrain (uneven terrain locomotor training) to compare the effects. The trial seeks individuals with a lower leg amputation who regularly use a prosthetic and can walk for three minutes at a time, even with an assistive device. As an unphased trial, this study provides a unique opportunity to improve mobility and confidence through a new walking program.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this uneven terrain locomotor training is safe for lower limb prosthesis users?

Research has shown that people with lower limb prostheses generally handle walking on uneven ground well. One study found that this type of walking can enhance safety by reducing pressure on the residual limb, resulting in less stress.

Although large-scale data is limited, smaller studies and personal stories suggest that individuals adapt to uneven surfaces over time. This training helps them become more confident and skilled at navigating various types of terrain.

Overall, while users may experience some initial discomfort during adjustment, training on uneven terrain appears safe and beneficial for improving mobility in those with prosthetic limbs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about uneven terrain locomotor training for amputation rehabilitation because it mimics real-world walking conditions more effectively than traditional flat surface training. Unlike walking on a flat treadmill, which doesn't challenge balance and coordination, uneven terrain training helps individuals adapt to the unpredictable surfaces they encounter daily. This innovative approach could significantly improve mobility and confidence, providing a more comprehensive rehabilitation experience for those with amputations.

What evidence suggests that this trial's treatments could be effective for improving walking skill and confidence in lower limb prosthesis users?

This trial will compare flat terrain training with uneven terrain training for individuals with lower limb prostheses. Research has shown that walking on uneven ground can enhance walking skills for these individuals. One study found that when people with amputations walk on bumpy surfaces, their joints move slightly differently, indicating the body's ability to adjust to these challenges. Another study highlighted that walking on uneven ground is crucial for prosthesis users, as it boosts confidence in everyday movement. Although uneven terrain might seem more challenging, it can train the body to handle various surfaces better, potentially reducing falls and improving overall mobility. ^{1 3 4 6 7}

Who Is on the Research Team?

Jenny A Kent, PhD, CSci

Principal Investigator

University of Nevada, Las Vegas

Are You a Good Fit for This Trial?

This trial is for individuals with lower limb prostheses due to amputations ranging from below the knee to hip disarticulation. It aims to help them improve their walking skills and confidence on different terrains.

Inclusion Criteria

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

I use a walking aid for daily activities.

Good socket fit, assessed by a score of 8-10 on the socket fit comfort scale

Exclusion Criteria

Pregnancy

I have a leg or foot ulcer, or another condition that hurts when I stand or walk.

My skin is fragile and could be damaged by walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo walking practice on either flat or uneven terrain three times per week for four weeks

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flat terrain locomotor training
• Uneven terrain locomotor training

Trial Overview The study tests a walking program that trains participants on uneven terrain, compared to traditional flat terrain training, in order to enhance mobility and safety for prosthesis users.

How Is the Trial Designed?

Group I: Uneven terrain training Experimental Treatment 1 Intervention

Walking on an uneven terrain treadmill or mat.

Group II: Flat terrain training Active Control 1 Intervention

Walking on a standard, flat treadmill or mat.

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Chapman University

Collaborator

Trials

10

Recruited

920+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A structured protocol for testing lower limb prostheses emphasizes safety, requiring users to meet specific graded safety levels before progressing to more challenging environments.

This approach aims to reduce the risk of falls and injuries, thereby enhancing user confidence and overall experience with active prosthetic legs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. Thesleff, A., Ahkami, B., Anderson, J., et al.[2022]

In a study of 42 patients with dysvascular lower extremity amputation, significant improvements were observed in physical function measures during the prosthetic training phase, including walking distance, gait speed, and timed mobility tasks, all showing statistically significant enhancements (P < .001).

Despite these improvements, patients' gait speed and mobility remained below clinically important thresholds, suggesting ongoing limitations in community ambulation and an increased risk of falls, highlighting the need for tailored rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Outcomes After the Prosthetic Training Phase of Rehabilitation After Dysvascular Lower Extremity Amputation. Christiansen, CL., Fields, T., Lev, G., et al.[2022]

The study developed a safe and effective method to induce unexpected trips in lower-limb amputees, using a polypropylene wire and a safety harness to prevent falls, allowing for the analysis of balance recovery responses.

Results showed that recovery strategies differed based on which limb was tripped; participants could adjust their movements to recover from trips on their sound limb but struggled to do so when tripped on their prosthetic limb, highlighting the need for improved prosthetic design to enhance balance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Experimental Approach to Induce Trips in Lower-Limb Amputees. Rodacki, ALF., Buckley, JG., Passos de Oliveira, AC., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-lower-limb-amputation-below-knee-injury-6-2024-84a45

Terrain Locomotor Training for Amputation (PROSPER 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0167945725000533

Effects of prosthetic ankle stiffness on adaptation to uneven ... On average, individuals with amputation exhibited relatively small changes in joint dynamics when walking on uneven terrain compared to level ground.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6360756/

Uneven terrain exacerbates the deficits of a passive ... The aim of this study was to explore L in individuals with a transtibial amputation, when challenged by an uneven surface.

4. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2022.2138989

Exploring meaningful outcome domains of recovery ... For example, the ability to manage stairs, slopes, and uneven ground were viewed as essential skills, which then enabled the valued outcome of being able to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7646606/

Effects of microprocessor-controlled prosthetic knees on ... Increased metabolic energy expenditures, decreased walking speeds, increased stumble and fall frequencies, and increased difficulty negotiating uneven terrains, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6664837/

Prosthetic Rehabilitation in the Lower Limb - PMC Amputation Techniques and Predictors of Rehabilitation Outcomes ... safety especially on uneven terrain, and reduced peak pressures on the residual limb.

7. physio-pedia.com physio-pedia.com/Older_People_with_Amputations

Older People with Amputations ... uneven terrain with his prosthetic limb, on discharge from rehab. Pain: moderate to severe in residual limb for 2 days post-op, minimal pain since then. Nil ...