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Not yet recruiting NCT07731022

Video Feedback-Supported Rehabilitation After Bilateral Femoral Lengthening

No phase Interventional Bone Lengthening Gait Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video Feedback-Supported Gait Training, Conventional Physiotherapy.
Who it may be relevant to
Registry conditions: Bone Lengthening, Gait Disorders. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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.
  • Other 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • \- 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

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

Identifiers

NCT: NCT07731022 · IAU-FTR-LON-VFB-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗