Comorbidity Screening and Referral by Prosthetists

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

January 30, 2023

Study Completion Date

January 30, 2023

Conditions
Limb IschemiaLow Back PainDepressionNeuropathy;PeripheralAmputation
Interventions
OTHER

Standard-of-Care

Participants with a major unilateral transfemoral or transtibial amputation will undergo a standardized medical history and medication review, complete questionnaires evaluating prosthesis use, comfort, and mobility, receive a clinical examination of height, weight and limb circumference, and complete three performance-based mobility outcome measures.

OTHER

Clinical Screening

Participants will complete the following self-report questionnaires: (a) the Patient Health Questionnaire-9 item, which may suggest major depression and/or suicidal ideation; and (b) the STarT Back Screening Tool, a 6-item tool used to screen for greater than low-risk for persistent, bothersome and disabling low back pain. Prosthetists will perform palpation of the contralateral dorsalis pedis and posterior tibial pulses and note presence or absence, as an indicator of peripheral arterial disease. Prosthetists will evaluate protective sensation of the contralateral foot through Semmes-Weinstein monofilament assessment of the great toe, the 1st and 3rd metatarsal heads. The prosthetist will record the results in a letter that is sent to the patient's primary care provider, and provide a copy of the letter to the patient after discussing the results for each of the screens.

Trial Locations (1)

19713

University of Delaware STAR Campus, Newark

All Listed Sponsors
collaborator

Independence Prosthetics-Orthotics, Inc.

UNKNOWN

collaborator

Orthotic and Prosthetic Education and Research Foundation (OPERF)

OTHER

lead

University of Delaware

OTHER