ACL Reconstruction Rehabilitation With Exercise and Psychological Support
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Rehabilitation with Exercise and Psychological Support (REPS).
- Кому может быть актуально
- Состояния в реестре: Anterior Cruciate Ligament Reconstruction Rehabilitation. Базовые параметры: 15 лет — 21 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The purpose of this study is to examine ACLR Rehabilitation with Exercise and Psychological Support (REPS), comparing two approaches for providing psychological support along with exercise during ACL reconstruction rehabilitation. In one group, physical therapists have received training that may boost emotional support during rehabilitation. In the other group, physical therapists will not have the training. Both groups will get similar exercises and participate in the same testing. Both groups will also watch short videos during rehabilitation that are specific to their group. Participants will not know to which group they are assigned until the end of the study. Participation will attend a total of four study visits over the course of 6 months, including 1 visit before the surgery and 3 visits during follow-up.
Подробное описание
The objective of this study is to examine the efficacy of Rehabilitation with Exercise and Psychological Support (REPS), a rehabilitation approach that integrates exercise with psychological support provided by physical therapist and patient training videos. The central hypothesis is that REPS will facilitate better psychological response (Specific Aim 1) and knee function (Specific Aim 2) than Standard Rehabilitation after ACL reconstruction. The feasibility, acceptability, and fidelity of implementing REPS will be explored. This is a pilot randomized controlled trial of 60 patients with ACL reconstruction who receive REPS or Standard Rehabilitation. Study participants in both treatment arms will receive exercise per a standard rehabilitation protocol. Physical therapists providing the REPS intervention will receive didactic training in psychologically informed practice principles and REPS procedures, clinical application practice, and regular feedback from the study team. Study participants in REPS will receive training videos on psychosocial aspects of recovery and mental skills to improve the psychological response. Study visits will occur prior to surgery (baseline), immediately before the first rehabilitation visit post-surgery, 3 months post-surgery, and 6 months post-surgery.
Study Aims Specific Aim 1. To examine the efficacy of REPS on psychological response after ACL reconstruction. Primary Hypothesis: Psychological readiness for sport, measured with the ACL Return to Sport after Injury (ACL-RSI) scale, will be higher in REPS than Standard Rehabilitation at 6 months post-surgery. Secondary Hypothesis: Kinesiophobia, measured with the Tampa Scale for Kinesiophobia (TSK-11) questionnaire, will be lower in REPS than Standard Rehabilitation at 6 months post-surgery.
Specific Aim 2. To examine the efficacy of REPS on knee function after ACL reconstruction. Hypothesis: Self-reported knee function, measured with the International Knee Documentation Committee (IKDC) subjective form, will be higher in REPS than Standard Rehabilitation at 6 months post-surgery.
Exploratory Aim. To assess the feasibility, acceptability, and fidelity of implementing REPS after ACL reconstruction. Research records will be used to assess the feasibility of REPS, and develop surveys for patients and clinicians will be used to assess the acceptability of REPS. In both treatment arms, patients will complete questionnaires that align with anticipated clinical changes in empathy (Consultation and Relational Empathy, CARE) and therapeutic alliance (Working Alliance Inventory-Short Revised, WAI-SR), and documentation templates will be used to record treatments and training for descriptive analysis of fidelity.
Вмешательства
- Поведенческое Rehabilitation with Exercise and Psychological Support (REPS)
Rehabilitation with Exercise and Psychological Support (REPS) is a rehabilitation approach that integrates exercise with psychological support provided by physical therapist and patient training videos.
Первичные конечные точки
- ACL Return to Sport after Injury (ACL-RSI) [Срок оценки: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery]
- International Knee Documentation Committee (IKDC) Subjective Form [Срок оценки: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery]
Вторичные конечные точки (7)
- Tampa Scale for Kinesiophobia (TSK-11) [Срок оценки: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery]
- Clinical Test (Knee pain) [Срок оценки: 3-months and 6-months post-surgery]
- Clinical Test (Knee range of motion) [Срок оценки: 3-months and 6-months post-surgery]
- Clinical Test (Quadriceps strength) [Срок оценки: 3-months and 6-months post-surgery]
- Clinical Test (Countermovement jump) [Срок оценки: 6-months post-surgery]
- Clinical Test (Single leg hop battery) [Срок оценки: 6-months post surgery]
- Clinical Test (Squat test) [Срок оценки: 3-months post-surgery]
Критерии участия
Критерии включения
- Age 15 to 21 years at the time of surgery;
- Pre-injury Tegner Activity Rating60 ≥ 5 (5=recreational sports, 10=elite sports);
- Sports participation at least 100 hours/year prior to injury;
- Intent to resume a pre-injury sport that requires cutting, jumping, or pivoting;
- ACL reconstruction performed ≤ 6 months from injury;
- ACL reconstruction performed with bone-patellar tendon-bone autograft or quadriceps tendon autograft; and
- Able to complete rehabilitation at one of the 4 participating TRIA locations.
Критерии исключения
- Previous ACL injury or surgery to either limb;
- Concomitant ligamentous injury > Grade II or requiring surgery; and
- Surgical procedure to articular cartilage requiring non-weight-bearing after surgery.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- TRIA — Bloomington
Идентификаторы
NCT: NCT06991192 · A23-019 · R21AR082572