Video Feedback-Supported Rehabilitation After Bilateral Femoral Lengthening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorIstanbul Aydın University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
- 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
Trial design
Design model
Parallel
Treatments tested in this trial
Video Feedback-Supported Gait Training
BehavioralParticipants 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.
Conventional Physiotherapy
Other interventionConventional 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Video Feedback-Supported RehabilitationExperimental treatment 2 interventions
Group B: Conventional PhysiotherapyActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.Secondary outcomes
1
Lower-Extremity Function
The Lower Extremity Functional Scale consists of 20 items assessing difficulty in performing daily activities. Each item is scored from 0 to 4, producing a total score ranging from 0 to 80. Higher scores indicate better lower-extremity function.
Time frame
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.2
Change in Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia is a 17-item self-reported questionnaire assessing fear of movement and reinjury. The total score ranges from 17 to 68. Higher scores indicate greater kinesiophobia.
Time frame
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.3
Change in Body Awareness Assessed With the Body Awareness Questionnaire
The Body Awareness Questionnaire is an 18-item self-reported questionnaire assessing attentiveness to normal bodily processes and changes. The total score ranges from 18 to 126. Higher scores indicate greater body awareness.
Time frame
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.4
Change in Quadriceps Muscle Strength Assessed With a Handheld Dynamometer
Quadriceps muscle strength will be measured using a MicroFET 2 handheld dynamometer. Participants will be assessed in a seated position with the hip and knee flexed to 90 degrees. Three measurements will be performed, and the mean value will be used. Higher values indicate greater quadriceps muscle strength.
Time frame
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.Sponsors and contacts
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Source ClinicalTrials.gov
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