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Набор скоро начнётся NCT07731022

Video Feedback-Supported Rehabilitation After Bilateral Femoral Lengthening

Без фазы С лечением Bone Lengthening Gait Disorders

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: Video Feedback-Supported Gait Training, Conventional Physiotherapy.
Кому может быть актуально
Состояния в реестре: Bone Lengthening, Gait Disorders. Базовые параметры: 18 лет — 45 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effects of Video Feedback-Supported Rehabilitation on Functional Outcomes in Individuals Undergoing Cosmetic Bilateral Femoral Lengthening: A Randomized Controlled Trial

Обзор

This randomized controlled study aims to investigate the effects of adding video feedback-supported gait training to a standard rehabilitation program in individuals undergoing cosmetic bilateral femoral lengthening surgery. A total of 32 adults aged 18-45 years who undergo cosmetic bilateral femoral lengthening using the Lengthening Over Nail (LON) technique will be included. All surgical procedures will be performed at Private Esencan Hospital. Participants will be monitored at the hospital for the first 6 postoperative days, and the distraction phase will begin on postoperative day 7. After discharge, rehabilitation will continue at BNB Health Services and Consultancy Center. Participants will be assigned to an intervention group or a control group using block randomization at a 1:1 ratio. Both groups will receive rehabilitation 5 days per week, with each session lasting 50 minutes. The control group will receive 50 minutes of conventional physiotherapy. The intervention group will receive 40 minutes of conventional physiotherapy and 10 minutes of video feedback-supported gait training. Assessments will be performed before surgery (T0), when approximately 4 cm of lengthening has been achieved (T1), when approximately 8 cm of lengthening has been achieved (T2), and 2 weeks after removal of the external fixator (T3). The primary outcome will be walking performance assessed using the 10-Meter Walk Test. Secondary outcomes will include lower-extremity function, kinesiophobia, body awareness, quadriceps muscle strength, and pressure pain threshold.

Подробное описание

Cosmetic limb-lengthening surgery has become increasingly common among individuals seeking an increase in height. The Lengthening Over Nail (LON) technique reduces the duration of external fixation and provides greater mechanical stability. However, the lengthening process affects not only bone tissue but also muscles, tendons, connective tissues, blood vessels, and the nervous system.

During distraction osteogenesis, approximately 1 mm of lengthening is generally performed each day. The resulting continuous mechanical tension on the soft tissues may lead to quadriceps tightness, reduced knee range of motion, loss of muscle strength, pain, and impaired functional performance. Joint stiffness, muscle-tendon problems, contractures, and alterations in gait may also occur during femoral lengthening. Therefore, intensive and structured rehabilitation is an essential component of the treatment process.

Video feedback allows individuals to observe their own movement patterns, recognize movement errors, and modify their motor strategies. Although visual and video feedback approaches have demonstrated beneficial effects on gait and motor performance in several patient populations, their effects have not been investigated in individuals undergoing cosmetic bilateral femoral lengthening.

This study is designed as a prospective, parallel-group, assessor-blinded randomized controlled trial. A total of 32 participants aged 18-45 years who undergo cosmetic bilateral femoral lengthening using the LON technique will be assigned to two groups through computer-generated block randomization at a 1:1 ratio.

Both groups will participate in rehabilitation sessions 5 days per week, with each session lasting 50 minutes. The control group will receive 50 minutes of conventional physiotherapy. The intervention group will receive 40 minutes of conventional physiotherapy in addition to 10 minutes of video feedback-supported gait training. Conventional physiotherapy will include active and passive range-of-motion exercises, stretching exercises for the quadriceps and hamstring muscles, isometric strengthening exercises, gait training, and neuromuscular electrical stimulation.

During video feedback-supported gait training, participants will be recorded while walking along a 10-meter walkway. Recordings will be obtained in the frontal and sagittal planes. Participants will review their gait videos with the physiotherapist and receive standardized verbal and visual feedback regarding step width, step symmetry, lateral trunk deviation, shoulder alignment, pelvic position, Trendelenburg sign, hip and knee movements, foot contact, and gait rhythm.

Assessments will be conducted before surgery (T0), at approximately 4 cm of lengthening (T1), at approximately 8 cm of lengthening (T2), and 2 weeks after external fixator removal (T3). All assessments will be performed by an outcome assessor who is blinded to group allocation.

The primary outcome will be walking performance measured using the 10-Meter Walk Test. Secondary outcomes will include the Lower Extremity Functional Scale, Tampa Scale for Kinesiophobia, Body Awareness Questionnaire, quadriceps muscle strength measured with a handheld dynamometer, and pressure pain threshold measured with a pressure algometer.

The study will determine whether adding video feedback-supported gait training to conventional physiotherapy provides greater improvements in walking performance, functional status, movement-related fear, body awareness, quadriceps muscle strength, and pressure pain threshold than conventional physiotherapy alone.

Вмешательства

  • Поведенческое Video Feedback-Supported Gait Training
    Participants will be recorded while walking on a 10-meter walkway in the frontal and sagittal planes. They will review the recordings with the physiotherapist and receive standardized visual and verbal feedback regarding step width, step symmetry, trunk alignment, pelvic position, Trendelenburg sign, lower-extremity movements, foot contact, and gait rhythm. The intervention will be administered for 10 minutes per session, 5 days per week throughout the distraction phase.
  • Другое Conventional Physiotherapy
    Conventional physiotherapy will include active and passive range-of-motion exercises, quadriceps and hamstring stretching, isometric strengthening exercises, gait training, and neuromuscular electrical stimulation. The experimental arm will receive 40 minutes and the active comparator arm will receive 50 minutes per session, 5 days per week throughout the distraction phase.

Первичные конечные точки

  • Change in Walking Speed Assessed by the 10-Meter Walk Test [Срок оценки: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.]
Вторичные конечные точки (5)
  • Lower-Extremity Function [Срок оценки: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.]
  • Change in Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia [Срок оценки: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.]
  • Change in Body Awareness Assessed With the Body Awareness Questionnaire [Срок оценки: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.]
  • Change in Quadriceps Muscle Strength Assessed With a Handheld Dynamometer [Срок оценки: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.]
  • Change in Pressure Pain Threshold Assessed With a Pressure Algometer [Срок оценки: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.]

Критерии участия

Критерии включения

  • Aged between 18 and 45 years
  • Scheduled to undergo cosmetic bilateral femoral lengthening surgery using the Lengthening Over Nail technique
  • Able and willing to participate regularly in the preoperative and postoperative assessments and rehabilitation program
  • Able to understand the study procedures and follow the physiotherapist's instructions
  • Willing to provide written informed consent

Критерии исключения

  • \- Presence of a congenital, neurological, or rheumatological disorder
  • Previous major orthopedic surgery affecting the lower extremities
  • Presence of cerebral palsy, muscular dystrophy, peripheral neuropathy, or another neuromuscular disorder
  • Advanced deformity, contracture, or osteoarthritis affecting the hip, knee, or ankle
  • Psychiatric illness or cognitive impairment that may affect participation or adherence
  • Any medical or postoperative complication preventing regular participation in the rehabilitation program
  • Considered unsuitable for continued participation by the treating physician or research team

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Private Esencan Hospital — Istanbul

Идентификаторы

NCT: NCT07731022 · IAU-FTR-LON-VFB-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗