Personalized Mobility Interventions for Amputation

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

66 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research is to analyze data from smartphone-based and wearable sensors, using advanced machine-learning and data-mining techniques, and to combine this information with performance-based measures, participant-reported measures, and structured interviews to create a clinical toolbox to (i) identify individuals who exhibit reduced prosthesis use (compared to expected usage levels based on K-level designation and/or participant goals of community mobility and social interaction), (ii) identify prosthetic/physical and psychological factors that limit prosthesis use, and (iii) determine the effect of targeted interventions to increase prosthesis use and facilitate achievement of participant goals. Objective sensor-based measurement of home and community activities will allow for the correlation of real-world function to in-clinic assessments and to monitor changes resulting from rehabilitation interventions in real time. Machine-learning and data mining techniques will be used to identify a subset of measures from this toolbox that sensitively and accurately reflect real-world function, enabling clinicians to predict and assess activity and provide effective interventions to optimize prosthesis use. The goal of this project, to improve overall performance with respect to activities of daily living and other real-world activities, thus addresses the Fiscal Year 2017 (FY17) Orthotics and Prosthetics Outcomes Research Program (OPORP) Focus Area of Orthotic or Prosthetic Device Function.

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 data supports the effectiveness of the treatment Needs-based intervention for Personalized Mobility Interventions for Amputation?

The study on the WiiNWalk intervention shows that group-based telerehabilitation can improve walking in older adults with lower limb amputation, suggesting that personalized mobility interventions may also be effective in enhancing mobility for amputees. ^{1 2 3 4 5}

How is the Needs-based intervention treatment for amputation different from other treatments?

The Needs-based intervention for amputation is unique because it focuses on personalized mobility interventions tailored to the specific needs of individuals with lower limb amputations, unlike standard treatments that may not be as individualized. This approach aims to improve mobility by considering personal and environmental factors, which is not typically addressed in conventional prosthetic or behavioral-based interventions. ^{3 6 7 8 9}

Research Team

Arun Jayaraman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

Unable or unwilling to provide informed consent

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Predicting Prosthetic Mobility at Discharge From Rehabilitation Following Major Amputation in Vascular Surgery. [2023]

2. Netherlands 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. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Validity and reliability of Turkish transcultural adaptation of the Prosthetic Limb Users Survey of Mobility. [2023]

4. England 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. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Quality of Life Associated Factors in a North African Sample of Lower Limbs Amputees. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

The Use of Physical Activity Outcomes in Rehabilitation Interventions for Lower Limb Amputees: a Systematic Review. [2023]

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

Construct Validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in Adults With Lower Limb Amputation. [2022]

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

The influence of environmental and personal factors on participation of lower-limb prosthetic users in low-income countries: prosthetists' perspectives. [2022]

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

Clinical Resources for Assessing Mobility of People with Lower-Limb Amputation: Interviews with Rehabilitation Clinicians. [2023]