- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07922785
Stair Biomechanics and Vibration Study After ACLR
Lower Extremity Biomechanics During Gait and Stair Negotiation and Effects of Vibratory Stimuli Following ACL Reconstruction
This study examines how people who have had anterior cruciate ligament reconstruction (ACLR) move their legs during walking and stair negotiation, and whether a single session of vibration changes how they ascend and descend stairs.
Participants with ACLR (1 to 3 years after surgery) complete three laboratory visits. At the first visit, they complete walking, stair negotiation, muscle strength, hopping tests, and questionnaires, and stair negotiation is measured before and after a control condition without vibration. At the second and third visits, they receive whole-body vibration (standing on a vibrating platform) or local muscle vibration (a device placed over the thigh muscle) in a counterbalanced order, and stair negotiation is measured before and after each vibration session. Healthy participants matched by sex, age, and activity level complete one visit with the same tests as the first ACLR visit, for comparison.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
Individuals with ACLR commonly show altered lower extremity biomechanics and quadriceps dysfunction that may contribute to the development of knee osteoarthritis. Stair negotiation places greater demands on the knee than level walking, yet findings on stair biomechanics after ACLR are inconsistent. Whole-body vibration (WBV) and local muscle vibration (LMV) acutely improve quadriceps function and gait biomechanics after ACLR, but their effects on stair biomechanics are unknown.
Aims: 1. to compare lower extremity biomechanics during gait, stair ascent, and stair descent between individuals 1 to 3 years after ACLR and matched healthy controls; 2. to determine inter-limb differences in biomechanics during gait and stair negotiation within individuals with ACLR; 3. to evaluate the acute effects of WBV and LMV on stair ascent and descent biomechanics in individuals with ACLR compared with a control condition.
Design: a case-control comparison nested within a single-blind, repeated-measures crossover design. ACLR participants complete three visits separated by at least 48 hours. Visit 1 is a baseline session with stair biomechanics assessed before and after a control condition (no vibration), plus gait biomechanics, isometric quadriceps and hamstring strength, single-leg and triple hop tests, and patient-reported outcomes. At visits 2 and 3, participants receive WBV and LMV in counterbalanced order, with stair biomechanics assessed immediately before and after the intervention. For all conditions, participants hold a squatted position (approximately 60 degrees of knee flexion) for 1 minute, repeated 6 times with 2 minutes of rest. WBV is delivered via a vibrating platform (30 Hz, 2 g). The control condition uses the same posture and timing without vibration. Healthy controls complete one visit identical to ACLR visit 1.
Biomechanics are collected with 3D motion capture synchronized with force plates under the second and third steps of an instrumented staircase. The data collector and outcome assessor are blinded to the vibration condition, which is administered by a separate research assistant.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Sansung Hwang, MS
- Telefonszám: 984-291-4830
- E-mail: sansungh@unc.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Troy Blackburn, PhD
- E-mail: troyb@unc.edu
Tanulmányi helyek
-
-
North Carolina
-
Chapel Hill, North Carolina, Egyesült Államok, 27599
- Motion Analysis Laboratory, University of North Carolina at Chapel Hill
-
Kapcsolatba lépni:
- Sansung Hwang, MS
- Telefonszám: 984-291-4830
- E-mail: sansungh@unc.edu
-
Kapcsolatba lépni:
- Troy Blackburn, PhD
- E-mail: troyb@unc.edu
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria (all participants):
- Age 18 to 39 years
- Able to read, understand, and communicate in English sufficiently to provide informed consent and follow instructions
Inclusion Criteria (ACLR group):
- Primary, unilateral ACL reconstruction with patellar tendon autograft
- 1 to 3 years after ACL reconstruction
- Cleared by surgeon to return to unrestricted physical activity
- Returned to unrestricted walking, stair negotiation, and hopping activities
Exclusion Criteria (ACLR group):
- History of ACL injury to the opposite leg
- History of any knee surgery other than ACL reconstruction
- Diagnosis of osteoarthritis in any joint in either leg
- Major lower extremity injury (requiring surgery or more than 3 weeks of medical treatment) in the previous 6 months
- History of neurological disorder (e.g., stroke, cerebral palsy, multiple sclerosis)
- Currently pregnant
Inclusion Criteria (healthy controls):
- No history of ACL injury or knee surgery
- No history of major lower extremity injury (requiring surgery or more than 3 weeks of medical treatment)
- Matched to an ACLR participant by sex, age (within 3 years), and Tegner activity level (within 1 level)
Exclusion Criteria (healthy controls):
- Diagnosis of osteoarthritis in any joint in either leg
- Major lower extremity injury in the previous 6 months
- History of neurological disorder (e.g., stroke, cerebral palsy, multiple sclerosis)
- Currently pregnant
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: ACLR: WBV then LMV
Visit 1 control condition; Visit 2 whole-body vibration; Visit 3 local muscle vibration (at least 48 hours apart) |
Standing on a vibrating platform (Power Plate Pro 5) in a squatted position (approximately 60 degrees of knee flexion), 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Más nevek:
A vibration device secured over the quadriceps muscle belly while standing in the same squatted position on the deactivated platform, 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Más nevek:
Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration. |
|
Kísérleti: ACLR: LMV then WBV
Visit 1 control condition; Visit 2 local muscle vibration; Visit 3 whole-body vibration (at least 48 hours apart) |
Standing on a vibrating platform (Power Plate Pro 5) in a squatted position (approximately 60 degrees of knee flexion), 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Más nevek:
A vibration device secured over the quadriceps muscle belly while standing in the same squatted position on the deactivated platform, 30 Hz, 2 g, 1 minute x 6 exposures with 2 minutes of rest.
Más nevek:
Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration. |
|
Egyéb: Healthy controls
Single visit with the control condition; matched to ACLR participants by sex, age, (within 3 years), and Tegner activity level (within 1 level). |
Same squatted position and timing (1 minute x 6 exposures with 2 minutes of rest) without vibration. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Peak Hip Flexion Angle
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Maximum hip flexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Peak Knee Flexion Angle
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Maximum hip flexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Peak Ankle Flexion Angle
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Maximum ankle dorsiflexion angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Knee Valgus Angle
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak knee valgus (abduction) angle during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Knee Flexion Displacement
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Change in knee flexion angle from initial contact to peak knee flexion during stance (degrees). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Sagittal Plane Knee Moment
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak internal knee extension moment during stance, normalized to body weight x height. Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Frontal Plane Knee Moment
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak internal knee abduction moment (equivalent to the external knee adduction moment) during stance, normalized to body weight x height. Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Peak Vertical Ground Reaction Force
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak vertical ground reaction force during stance, normalized to body weight (xBW). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Anterior Tibial Shear Force
Időkeret: Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
Peak anterior tibial shear force during stance, normalized to body weight (xBW). Measured with 3D motion capture and force plates during the stance phase of preferred-speed overground gait, stair ascent, and stair descent (5 trials per task, averaged), in both limbs of participants with ACLR and healthy controls. |
Gait: visit 1. Stair ascent and descent: visit 1 before and after the control condition, and visits 2 and 3 immediately before and after vibration (visits at least 48 hours apart, within about 2 weeks).
|
|
Isometric Quadriceps Peak Torque
Időkeret: Visit 1 (baseline)
|
Maximal voluntary isometric knee extension torque measured on an isokinetic dynamometer (knee flexed 90 degrees, hip flexed 85 degrees); mean of 3 contractions per limb, normalized to body mass (Nm/kg). |
Visit 1 (baseline)
|
|
Isometric Hamstring Peak Torque
Időkeret: Visit 1 (baseline)
|
Maximal voluntary isometric knee flexion torque measured on an isokinetic dynamometer (knee flexed 90 degrees, hip flexed 85 degrees); mean of 3 contractions per limb, normalized to body mass (Nm/kg). |
Visit 1 (baseline)
|
|
Quadriceps Rate of Torque Development
Időkeret: Visit 1 (baseline)
|
Rate of torque development during maximal voluntary isometric knee extension contractions; mean of 3 contractions per limb, normalized to body mass (Nm/kg/s). |
Visit 1 (baseline)
|
|
Hamstring Rate of Torque Development
Időkeret: Visit 1 (baseline)
|
Rate of torque development during maximal voluntary isometric knee flexion contractions; mean of 3 contractions per limb, normalized to body mass (Nm/kg/s). |
Visit 1 (baseline)
|
|
Single-Leg Hop for Distance
Időkeret: Visit 1 (baseline)
|
Distance hopped on one leg, measured from the take-off line to the landing point of the heel; mean of 3 successful trials per limb (cm). |
Visit 1 (baseline)
|
|
Triple Hop for Distance
Időkeret: Visit 1 (baseline)
|
Distance covered in three consecutive hops on one leg, measured from the take-off line to the landing point of the heel; mean of 3 successful trials per limb (cm). |
Visit 1 (baseline)
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Subjective Knee Form
Időkeret: Visit 1 (baseline)
|
Self-reported knee symptoms, function, and sports activity; score 0 to 100, higher scores indicate better knee function. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
Időkeret: Visit 1 (baseline)
|
Five subscales (Pain, Symptoms, Activities of Daily Living, Sport and Recreation, Knee-Related Quality of Life), each scored 0 to 100, higher scores indicate fewer problems. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Tampa Scale of Kinesiophobia (TSK-11)
Időkeret: Visit 1 (baseline)
|
Fear of movement and re-injury; score 11 to 44, higher scores indicate greater fear. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Tegner Activity Scale
Időkeret: Visit 1 (baseline)
|
Activity level; score 0 to 10, higher scores indicate higher activity levels. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Marx Activity Rating Scale
Időkeret: Visit 1 (baseline)
|
Frequency of running, cutting, decelerating, and pivoting; score 0 to 16, higher scores indicate more frequent activity. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
Anterior Cruciate Ligament Quality of Life (ACL-QOL) Questionnaire
Időkeret: Visit 1 (baseline)
|
ACL-specific quality of life; score 0 to 100, higher scores indicate better quality of life. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
|
ACL Reasons Survey
Időkeret: Visit 1 (baseline)
|
Self-reported return-to-activity status and reasons for limited physical activity after ACL injury. The survey has no total score. Responses will be reported descriptively as the number (%) of participants cleared to return to unrestricted activity, the number (%) in each activity category (as physically active as before injury; as active but participation is more challenging; less active than before injury), the number (%) selecting each of the 14 listed reasons, and the number (%) ranking each reason as most important. Reported for participants with ACLR. Baseline patient-reported measure collected for participant characterization and prespecified covariate analyses. |
Visit 1 (baseline)
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Sansung Hwang, MS, University of North Carolina, Chapel Hill
- Tanulmányi szék: Troy Blackburn, PhD, University of North Carolina, Chapel Hill
Publikációk és hasznos linkek
Általános kiadványok
- Pamukoff DN, Pietrosimone B, Ryan ED, Lee DR, Brown LE, Blackburn JT. Whole-Body Vibration Improves Early Rate of Torque Development in Individuals With Anterior Cruciate Ligament Reconstruction. J Strength Cond Res. 2017 Nov;31(11):2992-3000. doi: 10.1519/JSC.0000000000001740.
- Pamukoff DN, Pietrosimone B, Lewek MD, Ryan ED, Weinhold PS, Lee DR, Blackburn JT. Whole-Body and Local Muscle Vibration Immediately Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction. Arch Phys Med Rehabil. 2016 Jul;97(7):1121-9. doi: 10.1016/j.apmr.2016.01.021. Epub 2016 Feb 8.
- Troy Blackburn J, Dewig DR, Johnston CD. Time course of the effects of vibration on quadriceps function in individuals with anterior cruciate ligament reconstruction. J Electromyogr Kinesiol. 2021 Feb;56:102508. doi: 10.1016/j.jelekin.2020.102508. Epub 2020 Nov 28.
- Blackburn T, Padua DA, Pietrosimone B, Schwartz TA, Spang JT, Goodwin JS, Dewig DR, Johnston CD. Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury. J Orthop Res. 2021 May;39(5):1113-1122. doi: 10.1002/jor.24821. Epub 2020 Aug 12.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 26-0478
- 26-SRC049 (Egyéb azonosító: UNC-CH Scientific Review Committee)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Individual participant data will not be shared outside the research team. Study results will be reported in aggregate in publications and presentations, and the informed consent does not include provisions for sharing individual-level data with other researchers or public repositories.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .