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临床试验/NCT07731022
NCT07731022尚未招募不适用

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

Istanbul Aydın University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Change in Walking Speed Assessed by the 10-Meter Walk Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will be blinded to group allocation. Group assignment information will be known only to the physiotherapist delivering the interventions.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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

结局指标

主要结局

Change in Walking Speed Assessed by the 10-Meter Walk Test

时间窗: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.

Walking speed will be assessed on a 14-meter walkway. The first 2 meters will be used for acceleration and the final 2 meters for deceleration. The time required to walk the middle 10 meters at a comfortable speed will be recorded in seconds using a digital stopwatch. Walking speed will be calculated in meters per second. The test will be performed twice, and the mean value will be used. Higher walking speed indicates better walking performance.

次要结局

  • Lower-Extremity Function(Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.)
  • Change in Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia(Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.)
  • Change in Body Awareness Assessed With the Body Awareness Questionnaire(Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.)
  • Change in Quadriceps Muscle Strength Assessed With a Handheld Dynamometer(Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.)
  • Change in Pressure Pain Threshold Assessed With a Pressure Algometer(Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.)

研究者

发起方
Istanbul Aydın University
申办方类型
Other
责任方
Principal Investigator
主要研究者

FATMA ÇAVDARCI

Specialist Physiotherapist

Istanbul Aydın University

研究点 (1)

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