Stability Measurement for Lower Limb Amputation

(CS Trial)

Overseen By Jason Maikos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active wounds, Rapid limb volume changes, Cognitive deficits, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a simple method for healthcare providers to measure stability in individuals who have lost a lower limb. Stability is vital for physical activity and strength, both crucial for enhancing mobility and quality of life. The trial will test whether wearable technology can reliably measure this stability, simplifying progress tracking in clinics. It seeks participants who have lost a lower leg, have a well-fitting prosthesis, and can move independently. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility tracking and improve quality of life for many.

What prior data suggests that this method is safe for measuring inter-limb stability in Veterans with lower limb loss?

Research has shown that using 3D motion capture and wearable devices in clinical settings is generally safe for people. These technologies often study and understand human movement, which proves especially useful in medical and rehabilitation settings. No reports have indicated harm from these technologies in these environments.

Wearable devices commonly track walking and movement, effectively collecting accurate information without causing major side effects or discomfort.

This study aims to assess how well people with lower limb amputations can maintain balance using these technologies. Strong evidence supports the safety and comfort of these methods for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on understanding the stability of lower limbs after amputation using cutting-edge technology. Unlike traditional methods that rely heavily on subjective assessments, this trial employs 3D motion capture and wearable devices to objectively measure inter-limb stability. This approach offers a comprehensive and precise analysis of movement, which could lead to more personalized rehabilitation strategies and improved functional outcomes for amputees. By harnessing these advanced tools, the trial has the potential to redefine how stability is measured and enhance the quality of life for those with limb amputations.

What evidence suggests that this method is effective for measuring stability in lower limb amputation?

Research has shown that 3D motion capture and wearable devices can track balance in individuals who have lost a leg. This trial will assess participants for the reliability and validity of inter-limb stability using these tools. These devices measure steadiness, aiding in improved mobility. Wearable sensors hold promise as they track movement in daily life, proving useful for recovery. They offer insights that can enhance physical activity and strength. Although data on the reliability of these tools remains limited, early studies suggest they could benefit people with leg amputations. ^{6 7 8 9 10}

Who Is on the Research Team?

Alexis Sidiropoulos, PhD

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

This trial is for Veterans who have lost a lower limb and are seeking to improve their mobility. Participants should be interested in using technology like 3D motion capture and wearable devices to track their stability during movement.

Inclusion Criteria

I have lost one leg below the knee.

Well-fitting prosthesis for a minimum of one month as determined by a board-certified prosthetist

I can move around and transfer with minimal help.

Exclusion Criteria

My prosthetic socket does not fit well.

I have wounds or severe joint issues on my intact limb affecting movement tests.

I have no mental conditions that affect my understanding or ability to follow directions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including TUG, 6MWT, SAI, HAI, and AMPPro tests

1 week

1 visit (in-person)

Reliability Testing

Participants undergo 3 sessions of 3-D gait analysis and wearable technology assessment to measure test re-test reliability

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main assessments

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview The study aims to test the reliability and validity of measuring continuous inter-limb stability in individuals with lower limb loss. It will use accessible technologies, such as wearable devices, compared to expensive lab equipment.

How Is the Trial Designed?

Group I: Reliability and Validity Experimental Treatment 1 Intervention

Reliability and Validity of Inter-limb Stability using 3D motion capture, functional outcome measures, and wearable devices

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06987019

Reliability and Validity of Continuous Inter-limb Stability To date, there is no valid and reliable measure of continuous inter-limb stability available to healthcare teams treating people with lower limb loss.

2. withpower.com withpower.com/trial/stability-measurement-for-lower-limb-amputation-9ad8b

Stability Measurement for Lower Limb Amputation (CS Trial) Participants should be interested in using technology like 3D motion capture and wearable devices to track their stability during movement. Inclusion Criteria.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32356753/

Wearable Sensors Quantify Mobility in People With Lower ... The purpose of this study was to explore the clinical viability of using wearable sensors to characterize the functional mobility of people with lower limb ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8955603/

Reported Outcome Measures in Studies of Real-World ... This scoping review aims to provide an overview of the purpose of use of wearable activity monitors in people with a Lower Limb Amputation (LLA) in the real ...

5. pastel.hal.science pastel.hal.science/tel-03136343/document

Contribution to the development and validation of wearable ... One key objective during the rehabilitation of people with lower-limb amputation fitted with a prosthesis is the restoration of a physiological ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10416907/

Motion Capture Technologies for Ergonomics Motion capture (MoCap) is used for recording the movement of people for clinical, ergonomic and rehabilitation solutions.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0268003323001195

Using embedded prosthesis sensors for clinical gait ... The purpose of this study was to investigate the possibility of accurately measuring gait parameters using embedded sensors in a microprocessor-controlled knee ...

8. nature.com nature.com/articles/s41597-020-0494-7

A kinematic and kinetic dataset of 18 above-knee ... Motion capture is necessary to quantify gait deviations in individuals with lower-limb amputations. However, access to the patient ...

9. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01530-7

Methods to assess lower limb prosthetic adaptation The predominant methods for assessing lower-limb prosthetic fitting include mobility evaluation, gait analysis, measurement of physical variables, and ...

10. mdpi.com mdpi.com/2076-3417/15/12/6703

A Comparative Study of the Effects of Augmented Reality ... Ten individuals with unilateral lower limb amputations participated. Joint range of motion during exercises was measured using a 3D motion capture system.