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

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 9 11 12 13}

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

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

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.

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

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+

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.

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Functional Outcomes After the Prosthetic Training Phase of Rehabilitation After Dysvascular Lower Extremity Amputation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of terrain on metabolic and temporal gait characteristics of unilateral transtibial amputees. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Physical Performance Limitations After Severe Lower Extremity Trauma in Military Service Members. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Variations in 2-Minute Walk Test outcomes for people with lower limb amputation in the outpatient clinic and research settings. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Lead limb loading during a single-step descent in persons with and without a transtibial amputation in the trailing limb. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An Experimental Approach to Induce Trips in Lower-Limb Amputees. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Amputee locomotion: lower extremity loading using running-specific prostheses. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Kinematic analysis of males with transtibial amputation carrying military loads. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The effects of ground-irregularity-cancelling prosthesis control on balance over uneven surfaces. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Obstacle crossing in lower limb amputees. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

A Unified Controller for Walking on Even and Uneven Terrain With a Powered Ankle Prosthesis. [2019]