50 Participants Needed

Mobility Assessment for Amputation

PK
Overseen ByPaul Kline
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Virginia Commonwealth University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve understanding of how people with lower limb amputations navigate their communities. It focuses on both walking with a prosthetic limb and using wheeled devices like wheelchairs or scooters. This research is important because many people with amputations struggle to walk everywhere, especially outside their homes. Individuals who have had an amputation through or above the ankle, have a prosthetic limb, and use a wheelchair or scooter at least once a week might be suitable for this trial. As an unphased study, this trial offers participants the opportunity to contribute valuable insights that could enhance mobility solutions for amputees.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobility assessment is safe for individuals with lower limb amputation?

Research has shown that many people with lower limb amputation (LLA) experience difficulty with mobility. With rehabilitation and training, some regain the ability to walk, but only about 25 to 58% achieve this. Less than half of these individuals walk well enough to navigate their community. This trial examines both walking and the use of aids like wheelchairs to assist with mobility outside the home.

In terms of safety, the trial evaluates different ways to measure mobility rather than testing a new drug or medical device. Therefore, there is no risk of side effects or adverse events from the treatment itself. The goal is to understand how people with LLA move and how different methods can enhance their mobility and quality of life.12345

Why are researchers excited about this trial?

Researchers are excited about the Mobility Assessment for Amputation trial because it focuses on understanding how people with lower limb amputations navigate their communities, whether they walk or use other means. Unlike traditional approaches that might focus only on physical rehabilitation, this trial aims to provide insights into daily mobility challenges faced by amputees. By assessing both ambulatory and non-ambulatory community mobility, the trial could lead to personalized strategies that improve independence and quality of life for those with amputations.

What evidence suggests that assessing ambulatory and non-ambulatory community mobility is effective for improving mobility after lower limb amputation?

Research has shown that moving around after losing a leg is difficult, with only 25-58% of people able to walk again. Even with rehab and prosthetic training, many still use wheelchairs or scooters for some activities. This trial will assess both walking and wheeled mobility in participants with lower limb amputation. By examining both methods of movement, more people might find it easier to go out and about, potentially improving their quality of life.12467

Who Is on the Research Team?

PK

Paul Kline

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals who have had a lower limb amputation and are navigating community mobility, whether they walk or use wheeled assistance like wheelchairs. Specific eligibility criteria were not provided.

Inclusion Criteria

I use a wheelchair or scooter for mobility at least once a week.
It has been over 6 months since my leg amputation and I use a prosthetic.
I have had one or both of my legs amputated above the ankle.
See 1 more

Exclusion Criteria

I do not have an unstable heart condition.
I currently have a serious infection.
I am not a prisoner or institutionalized with restricted mobility.
See 5 more

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 WHOQOL-BREF, Locomotor Capabilities Index, and other questionnaires

1 day
1 visit (in-person)

GPS and Accelerometry Monitoring

Participants are provided with GPS and accelerometry devices to monitor community mobility over 10-21 days

10-21 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Assessing Ambulatory and Non-ambulatory Community Mobility

Trial Overview

The study measures how people with lower limb amputations move around in their communities. Participants will learn to use GPS and activPAL devices to track their movements and complete questionnaires about their mobility.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Lower Limb Amputation (LLA) ParticipantsExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Citations

Study Details | NCT07387744 | Assessing Ambulatory and ...

With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ...

Assessing Ambulatory and Non-ambulatory Community ...

Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain ...

Community ambulation in people with lower limb amputation

Literature reports dissimilar data on percentages of amputees who successfully use the artificial limb after rehabilitation, ranging from 5% to ...

REVIEW ARTICLE Effectiveness and Equity in Community ...

Effectiveness and Equity in Community-Based Rehabilitation on Pain, Physical Function, and Quality of Life After Unilateral Lower Limb Amputation: A Systematic ...

Reported Outcome Measures in Studies of Real-World ...

The use of wearable technology to monitor real-world ambulatory activity in people with a Lower Limb Amputation (LLA) has grown rapidly in the past decade.

Functional Mobility and Fall Risk Assessment in Lower Limb ...

Background: Lower limb amputation (LLA) significantly affects mobility and increases fall risk, particularly in individuals with higher-level ...

Ambulation and functional outcome after major lower ...

It is unknown whether postamputation functional outcomes and outcome predictability have changed with a population of increasingly aging and obese patients.