Community mobility using walking and wheeled devices after lower limb amputation
Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation
Researchers will use wearable GPS and activity sensors to see how adults with lower limb amputation combine walking and wheeled mobility when they move around their communities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT07387744 on ClinicalTrials.gov |
What this trial studies
This interventional protocol provides participants with GPS and activPAL activity monitors, collects clinical descriptive measures, and administers questionnaires to capture real-world mobility behavior. Participants include people at least six months after major lower limb amputation who use a prosthesis and also use a wheelchair or scooter at least part of the week. The study links objectively monitored movement patterns to contextual factors and patient- and clinic-level measures to clarify how ambulatory and wheeled modes are used together. Results are intended to inform targeted rehabilitation strategies and assistive-technology decisions.
Who should consider this trial
Good fit: Adults with unilateral or bilateral major lower limb amputation who are >6 months post-amputation, fitted with a prosthetic limb, and who use a wheelchair or scooter at least part of a day each week are ideal candidates.
Not a fit: People who are medically unstable, institutionalized, decisionally impaired, undergoing active cancer treatment, actively engaged in prosthetic rehabilitation, or otherwise excluded by the investigators are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could help clinicians tailor rehabilitation and mobility-device choices so people with limb loss can get out into their communities more reliably.
How similar studies have performed: Prior research has largely focused on walking alone and used limited objective monitoring, so combining continuous GPS and activity-sensor monitoring with contextual and clinical data is relatively novel in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral or bilateral major lower limb amputation (e.g., proximal to or through the ankle joint) * \>6 months since LLA Fitted with a prosthetic limb * Fitted with a prosthetic limb * Use a wheelchair or scooter for mobility for part of a day at least once per week Exclusion Criteria: * Unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis) * Acute systemic infection Prisoner or institutionalized such that self-determined mobility is restricted * Prisoner or institutionalized such that self-determined mobility is restricted * Decisionally challenged individuals (Modified Telephone Interview for Cognitive Status score ≤24) * Undergoing active cancer treatment * Participating in prosthetic rehabilitation * Clinical discretion of the principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the protocol * Inability to communicate verbally in English
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Paul Kline — Virginia Commonwealth University
- Study coordinator: Paul Kline
- Email: klinep@vcu.edu
- Phone: 804-828-4483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.