35 Participants Needed

Terrain Locomotor Training for Amputation

(PROSPER Trial)

JA
Overseen ByJenny A Kent, PhD, CSci
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nevada, Las Vegas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of this treatment?

The study on the influence of terrain on walking in amputees shows that different ground surfaces affect walking speed and energy use, suggesting that training on various terrains could help improve walking ability and energy efficiency for amputees.12345

Is Terrain Locomotor Training for Amputation safe for humans?

Research on lower limb prostheses highlights the importance of safety protocols to prevent falls and injuries during training. Studies suggest that while there are risks like balance loss and increased load on certain limbs, safety measures such as harnesses and stepwise protocols can help manage these risks effectively.678910

How is uneven terrain locomotor training different from other treatments for amputation?

Uneven terrain locomotor training is unique because it focuses on helping individuals with lower-limb amputations walk on uneven surfaces by using a specialized prosthesis controller that adjusts to changes in terrain height. This approach aims to reduce disturbances and improve balance, which is not typically addressed by standard prosthetic devices.29111213

What is the purpose of 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.

Research Team

JA

Jenny A Kent, PhD, CSci

Principal Investigator

University of Nevada, Las Vegas

Eligibility Criteria

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
See 2 more

Exclusion Criteria

I have a leg or foot ulcer, or another condition that hurts when I stand or walk.
Pregnancy
My skin is fragile and could be damaged by walking.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Uneven terrain trainingExperimental Treatment1 Intervention
Walking on an uneven terrain treadmill or mat.
Group II: Flat terrain trainingActive Control1 Intervention
Walking on a standard, flat treadmill or mat.

Find a Clinic Near You

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+

Findings from Research

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

References

Functional Outcomes After the Prosthetic Training Phase of Rehabilitation After Dysvascular Lower Extremity Amputation. [2022]
Influence of terrain on metabolic and temporal gait characteristics of unilateral transtibial amputees. [2009]
Physical Performance Limitations After Severe Lower Extremity Trauma in Military Service Members. [2022]
Variations in 2-Minute Walk Test outcomes for people with lower limb amputation in the outpatient clinic and research settings. [2022]
Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. [2019]
Lead limb loading during a single-step descent in persons with and without a transtibial amputation in the trailing limb. [2022]
An Experimental Approach to Induce Trips in Lower-Limb Amputees. [2023]
Amputee locomotion: lower extremity loading using running-specific prostheses. [2022]
Kinematic analysis of males with transtibial amputation carrying military loads. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. [2022]
The effects of ground-irregularity-cancelling prosthesis control on balance over uneven surfaces. [2021]
Obstacle crossing in lower limb amputees. [2013]
13.United Statespubmed.ncbi.nlm.nih.gov
A Unified Controller for Walking on Even and Uneven Terrain With a Powered Ankle Prosthesis. [2019]
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