NCT07731022

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Nov 2026

First Submitted

Initial submission to the registry

July 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2026

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 21, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

Cosmetic Limb LengtheningBilateral Femoral LengtheningLengthening Over NailVideo FeedbackGait TrainingPhysical TherapyKinesiophobiaBody Awareness

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (5)

  • 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.

Study Arms (2)

Video Feedback-Supported Rehabilitation

EXPERIMENTAL

Participants will receive 40 minutes of conventional physiotherapy and 10 minutes of video feedback-supported gait training per session, 5 days per week throughout the distraction phase.

Behavioral: Video Feedback-Supported Gait TrainingOther: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Participants will receive 50 minutes of conventional physiotherapy per session, 5 days per week throughout the distraction phase.

Other: Conventional Physiotherapy

Interventions

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.

Video Feedback-Supported Rehabilitation

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.

Conventional PhysiotherapyVideo Feedback-Supported Rehabilitation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Esencan Hospital

Istanbul, Eyalet/Yerleşke, 34517, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mobility LimitationKinesiophobia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Ioakim Ipseftel, PhD

    Istanbul Aydın University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Çavdarcı, PhD Candidate, Physiotherapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to group allocation. Group assignment information will be known only to the physiotherapist delivering the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 32 participants will be randomly assigned in a 1:1 ratio to either the video feedback-supported rehabilitation group or the conventional physiotherapy group, with 16 participants in each arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physiotherapist

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 28, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 25, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because participant consent for external data sharing was not obtained.

Locations