Personalized Mobility Interventions for Amputation

Not currently recruiting at 2 trial locations

Overseen By Arun Jayaraman, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Stroke, Obesity, Severe TBI, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with leg amputations who use prosthetics but face mobility challenges. Researchers will analyze data from wearable sensors and smartphones to identify factors limiting prosthetic use, such as the prosthetic itself, physical issues, or psychological factors. Participants not meeting their mobility goals will receive personalized, needs-based interventions, like physical therapy or motivational support, to enhance their daily activities. Individuals with a lower limb amputation who can wear a prosthesis and have been struggling with its use might be well-suited for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could improve prosthetic mobility solutions for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these personalized mobility interventions are safe?

Research shows that people using artificial limbs for their legs have different needs. A detailed review of studies has identified these main needs. Understanding them helps researchers create better support methods for using prostheses. The personalized methods tested in this trial aim to meet these specific needs. Importantly, similar methods used in the past have not shown any major safety issues. These methods may include care for the prosthesis, physical therapy, or psychological support, which are generally safe and commonly used in regular care. Therefore, these treatments are considered safe for participants and focus on improving daily activities without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these personalized mobility interventions for amputation because they tailor treatment based on the individual's unique needs. Unlike standard approaches that might offer a one-size-fits-all solution like basic physical therapy or prosthetic adjustments, this intervention uses detailed sensor monitoring and expert panel assessments to customize the care plan. The treatment might include a mix of prosthetic care, physical therapy, and even psychological support like motivational interviewing. This bespoke approach aims to significantly improve prosthesis use and enhance overall mobility, offering hope for better long-term outcomes.

What evidence suggests that these personalized mobility interventions could be effective for improving prosthesis use?

Research has shown that personalized mobility programs can help people with amputations. In a previous study, 68% of participants who received these customized programs improved their ability to move or reached their mobility goals. Among those who improved, 46% exceeded expectations. In this trial, participants not meeting mobility goals after initial monitoring will receive a needs-based intervention tailored to their individual requirements. This intervention may include prosthetic care, physical therapy, or motivational support. The goal is to help people use their prostheses more effectively and achieve their daily activity goals. ^{6 7 8 9 10}

Who Is on the Research Team?

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-89 with lower-limb amputations at the transtibial or transfemoral level, who can wear a prosthesis and are classified as K-level 2 - 4. It's open to Veterans Affairs participants receiving care through their system. People with conditions like stroke, severe obesity, or neuralgia that limit prosthesis use independently of training aren't eligible.

Inclusion Criteria

I have had one or both of my legs amputated above or below the knee.

I can wear and use a prosthesis.

My mobility level is moderately to fully active.

Exclusion Criteria

Residing in an area with poor cell phone coverage

Unable or unwilling to provide informed consent

Unable or unwilling to learn to use the smartphone app or to allow transmission of study data

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Monitoring

Participants are monitored using sensors to assess prosthesis use and mobility goals

12 weeks

Regular monitoring through sensors

Intervention

Participants not meeting mobility goals receive targeted interventions such as prosthetic care, physical therapy, or motivational interviewing

12 weeks

Intervention visits as needed

Post-Intervention Monitoring

Participants are monitored to assess the maintenance of prosthesis use after intervention

12 weeks

Regular monitoring through sensors

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Needs-based intervention

Trial Overview

The study aims to improve how lower-limb prostheses are used by analyzing sensor data from smartphones and wearables using machine learning. The goal is to create tools for clinicians to identify usage issues and provide interventions based on real-world activity monitoring.

How Is the Trial Designed?

Group I: Not Meeting Mobility Goals Experimental Treatment 1 Intervention

After the first three months of sensor monitoring, participants not meeting goals will receive an intervention (others will be removed from the study). The intervention assigned is not pre-determined, but will be assigned by an expert panel based on the individual needs determined from the assessment results and monitoring data. The intervention may include prosthetic care, physical therapy, motivational interviewing or other related psychological interventions, or a combination thereof. After three months of intervention, assessments are performed again and if improvement in prosthesis use is determined, participants are monitored for another three months to assess maintenance of prosthesis use (participants showing no improvement are removed from the study before these final three months of monitoring).

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Published Research Related to This Trial

The WiiNWalk intervention, which involved modified Wii Fit activities, significantly improved balance confidence in older adults with lower limb amputation, but did not show a difference in walking capacity compared to a cognitive control group.

Despite no improvements in walking-related physical function, the intervention demonstrated potential benefits for balance confidence, particularly after the unsupervised phase, suggesting that rehabilitation games may need to be tailored specifically for individuals with amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based telerehabilitation intervention using Wii Fit to improve walking in older adults with lower limb amputation (WiiNWalk): A randomized control trial. Tao, G., Miller, WC., Eng, JJ., et al.[2022]

A review of 16 studies on interventions for increasing physical activity in individuals with lower limb amputation found that both behavioral and prosthetic approaches had similar methodological quality but mixed results in effectiveness.

There is a lack of comprehensive studies on the efficacy of behavioral interventions, and prosthetic interventions may require more advanced technology to achieve significant improvements in physical activity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Physical Activity Outcomes in Rehabilitation Interventions for Lower Limb Amputees: a Systematic Review. Jamieson, AG., Murray, L., Buis, A.[2023]

The Turkish version of the Prosthetic Limb Users Survey of Mobility (PLUS-M-T) has been validated as a reliable tool for assessing mobility in lower-limb amputees, showing high test-retest reliability (ICC = 0.85) and internal consistency (Cronbach alpha = 0.94).

There is a strong correlation between the PLUS-M-T scores and the Amputee Mobility Scale scores (r = 0.84), indicating that the PLUS-M-T effectively measures mobility in individuals using prosthetic limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and reliability of Turkish transcultural adaptation of the Prosthetic Limb Users Survey of Mobility. Yosmaoglu, S., Yazicioglu, G., Demir, Y., et al.[2023]

The Locomotor Capabilities Index-5 (LCI-5) demonstrated high reliability and sensitivity to change in assessing locomotor capabilities in 110 patients with lower limb amputation undergoing prosthetic training.

The study established a minimal clinically important difference (MCID) of 7 points on the LCI-5, indicating a meaningful improvement in locomotor function, with a larger improvement threshold set at 12 points, which can help guide patient assessments post-training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity to change and minimal clinically important difference of the Locomotor Capabilities Index-5 in people with lower limb amputation undergoing prosthetic training. Franchignoni, F., Traballesi, M., Monticone, M., et al.[2022]

Citations

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clinicaltrials.gov/study/NCT03930199

NCT03930199 | Personalized Mobility Interventions Using ...

The result of these assessments and analysis of sensor data will determine if the participant is meeting mobility goals and expected prosthesis use.

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medrxiv.org/content/10.1101/2025.07.21.25331936v1.full-text

Characterizing Response to Personalized Intervention in ...

Results Following intervention, 68% of participants improved in functional outcomes, goal attainment, or both. Among Responders, 46% exceeded ...

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Personalized Mobility Interventions for Amputation

The Needs-based intervention for amputation is unique because it focuses on personalized mobility interventions tailored to the specific needs of individuals ...

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The objective of this study was to determine whether the Evidence-Based Amputee Rehabilitation program would improve functional mobility of people with ...

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REVIEW ARTICLE Effectiveness and Equity in Community- ...

A beneficial effect was observed after (1) an 8-week evidence-based amputation rehabilitation exercise intervention compared to waitlist control at intervention ...

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pmc.ncbi.nlm.nih.gov/articles/PMC9636812/

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We have conducted a systematic review of the literature to extract important needs of the users of lower-limb prostheses. The review included 56 ...

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pmc.ncbi.nlm.nih.gov/articles/PMC8451817/

The Role of Earlier Receipt of a Lower Limb Prosthesis on ...

This study's results demonstrate that having a prosthesis earlier is protective against using the ED while controlling for age, sex, amputation level, and ...

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Virtual Assessment of Functional Mobility in Lower ...

Most participants reported significant ease of completing basic indoor ambulation and toileting tasks (66%-75%) and significant difficulty in running or ...

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clinicaltrials.gov/study/NCT03930199

Personalized Mobility Interventions Using Smart Sensor ...

The result of these assessments and analysis of sensor data will determine if the participant is meeting mobility goals and expected prosthesis use.

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Background/Objective: The most effective strategy for addressing users' prosthetic needs is a comprehensive clinical assessment that provides a holistic ...