- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07731022
Video Feedback-Supported Rehabilitation After Bilateral Femoral Lengthening
Effects of Video Feedback-Supported Rehabilitation on Functional Outcomes in Individuals Undergoing Cosmetic Bilateral Femoral Lengthening: A Randomized Controlled 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Fatma Çavdarcı, PhD Candidate, Physiotherapy
- Numero di telefono: +905374590918
- Email: cvdrcftm@gmail.com
Luoghi di studio
-
-
Eyalet/Yerleşke
-
Istanbul, Eyalet/Yerleşke, Turchia (Türkiye), 34517
- Private Esencan Hospital
-
Contatto:
- FATMA ÇAVDARCI, PhD Student
- Numero di telefono: 05374590918
- Email: cvdrcftm@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Video Feedback-Supported Rehabilitation
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.
|
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.
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.
|
|
Comparatore attivo: Conventional Physiotherapy
Participants will receive 50 minutes of conventional physiotherapy per session, 5 days per week throughout the distraction phase.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Walking Speed Assessed by the 10-Meter Walk Test
Lasso di tempo: 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.
|
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Lower-Extremity Function
Lasso di tempo: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
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.
|
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
|
Change in Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia
Lasso di tempo: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
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.
|
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
|
Change in Body Awareness Assessed With the Body Awareness Questionnaire
Lasso di tempo: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
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.
|
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
|
Change in Quadriceps Muscle Strength Assessed With a Handheld Dynamometer
Lasso di tempo: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
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.
|
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
|
Change in Pressure Pain Threshold Assessed With a Pressure Algometer
Lasso di tempo: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
Pressure pain threshold will be measured over the vastus lateralis using a Baseline dolorimeter.
The measurement point will be the midpoint between the greater trochanter and the lateral femoral condyle.
Three measurements will be performed, and the mean value in kilograms per square centimeter will be used.
Higher values indicate a higher pressure pain threshold and lower pressure sensitivity.
|
Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ioakim Ipseftel, PhD, Istanbul Aydın University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IAU-FTR-LON-VFB-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .