Outpatient Floor Pedal Bike Utilization

Обзор

The goals of this clinical trial are: to test the feasibility of identifying patients and getting patients the floor pedal bikes, to test how well floor pedal bikes help patients with lower body injuries heal, and to test methods of patient self-reported logs for home pedal bike use. Participants will be given a floor pedal bike at first post-operative appointment where weightbearing restrictions are lifted (weight-bearing as tolerated) along with instructions on utilization. Participants will be asked to complete patient reported outcome measure surveys at each follow-up visit.

Подробное описание

The goals of this clinical trial are:

1. to test the feasibility of identifying patients and getting patients the floor pedal bikes themselves 2. to test the efficacy of floor pedal bikes in the rehabilitation of patients with lower extremity orthopedic trauma injuries without formal physical therapy or as a supplement to preexisting and/or future physical therapy. We hope that these bikes will either supplement patient's preexisting therapy or allow them to complete therapy at home if they are unable to obtain formal physical therapy and 3. to test various methods of patient self-reported logs for home pedal bike utilization, whether electronic or hard paper copy.

Participants will be given a floor pedal bike at first post-operative appointment where weightbearing restrictions are lifted (weight-bearing as tolerated) along with instructions on utilization. Participants will be asked to complete patient reported outcome measure surveys at each follow-up visit.

Вмешательства

• Другое Floor Pedal Bike with Guided Instructions for Home
  Patients with lower extremity traumatic injuries that are medically clear for physically ready for therapy and will receive a floor pedal bike with guided exercises at home.

Первичные конечные точки

• Return to Work/Functional Activity [Срок оценки: Baseline, 3, 6, 12 months]

Вторичные конечные точки (10)

• Connor-Davidson Resilience Scale (CD-RISC) [Срок оценки: Baseline, 3, 6, 12 months]
• Tampa Scale for Kinesiophobia (TSK) [Срок оценки: Baseline, 3, 6, 12 months]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline, 3, 6, 12 months]
• Veterans RAND 12 Item Health Survey (VR-12) [Срок оценки: Baseline, 3, 6, 12 months]
• PROMIS Pain Interference Short Form [Срок оценки: 3, 6, 12 months]
• PROMIS Physical Function Short Form [Срок оценки: 3, 6, 12 months]
• Brief Pain Inventory (BPI) [Срок оценки: 3, 6, 12 months]
• Performance test - Timed up and go test [Срок оценки: 3, 6, 12 months]
• Performance test - Five time sit to stand test [Срок оценки: 3, 6, 12 months]
• Performance test - 10 meter walk test (Gait) [Срок оценки: 3, 6, 12 months]

Критерии участия

Критерии включения

• Patients >18 years of age
• Operative fractures of the femur, tibia and select ankle injuries
• Under the care of an orthopaedic surgeon
• English or Spanish competent
• 12 month follow up

Критерии исключения

• Type IIIB/C fracture
• Unable to provide consent/need for an LAR
• Major lower extremity peripheral nerve injury (ex. foot drop, sciatic nerve palsy, etc)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06586190 · IRB00101617

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗