- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07681193
Effects of Whole Body Vibration on Quadriceps Function, Landing Biomechanics, and Performance in Individuals With ACL Reconstruction
25 juni 2026 uppdaterad av: University of North Carolina, Chapel Hill
Use of Whole-body Vibration to Acutely Improve Landing Biomechanics In Individuals With Anterior Cruciate Ligament Reconstruction (ACLR)
Individuals who undergo anterior cruciate ligament reconstruction (ACLR) are at heightened risk of secondary anterior cruciate ligament (ACL) injury (e.g.
additional injury to the ACL in either knee).
One of the primary physiological consequences of ACLR is the presence of quadriceps dysfunction (i.e.
reduced activation and strength) which has been linked to altered gait and landing biomechanics.
Aberrant landing biomechanics have been associated with an increased risk of both primary and secondary ACL injury, thus additional research is needed to evaluate the efficacy of treatments aimed to reduce quadriceps dysfunction and restore adequate landing biomechanics in attempts to reduce secondary ACL injury.
Whole-body Vibration (WBV) has demonstrated success in improving quadriceps function and gait biomechanics in individuals with ACLR, however its effectiveness on landing biomechanics is unknown.
To evaluate the acute effects of WBV on landing biomechanics in those with ACLR, a non-randomized crossover-controlled trial was conducted to determine if a single bout of WBV improved landing biomechanics greater than a control condition.
Participants completed two separate testing sessions (separated by at least one week) in which measures of quadriceps function and landing biomechanics were assessed before and after either a control (no WBV) or WBV intervention.
Separate linear mixed-effects models of post-test values for each dependent outcome were conducted with condition (control vs WBV) and limb (ACLR vs Uninvolved) as an interaction term, and each condition pre-test values and time post-ACLR as fixed effect covariates and a random effect of subject.
The investigators expect to observe a significant improvement in landing biomechanics following WBV compared to the control condition.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- Univesrity of North Carolina at Chapel HIll MOTION Science Institute
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Between the ages of 18-35
- History of primary, unilateral ACLR
- Medically cleared for unrestricted physical activity
Exclusion Criteria:
- More than 5 years removed from ACLR
- Currently pregnant
- History of other lower extremity surgery
- History of lower extremity injury in previous 6 months
- History of neurological disorder
- Maximal isometric quadriceps torque > 3.0 Nm/kg in the ACLR limb
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Whole body vibration followed by No Intervention (Control)
Participants in this arm will receive Whole Body Vibration followed by a washout period of 1 week, then receive the Sham Whole body vibration (Control).
Each condition will be evaluated in a single session (i.e.
acute effects).
|
Participants will stand on a WBV platform in a mini-squat position while vibration is applied during six 60-second bouts with 2 minutes of rest between each bout.
WBV will be delivered at an acceleration of 2g and a frequency of 30 Hz.
Participants will stand on a WBV platform in a mini-squat position during six 60-second bouts with 2 minutes of rest between each bout.
No vibration will be applied.
|
|
Experimentell: Sham Whole body vibration (Control) followed by Whole Body Vibration
Participants in this arm will receive Sham Whole body vibration (Control) followed by a washout period of 1 week, then receive Whole Body Vibration.
Each condition will be evaluated in a single session (i.e.
acute effects).
|
Participants will stand on a WBV platform in a mini-squat position while vibration is applied during six 60-second bouts with 2 minutes of rest between each bout.
WBV will be delivered at an acceleration of 2g and a frequency of 30 Hz.
Participants will stand on a WBV platform in a mini-squat position during six 60-second bouts with 2 minutes of rest between each bout.
No vibration will be applied.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Internal Knee Adduction Moment (KAM)
Tidsram: Separate values prior to and immediately following the intervention (within 5 minutes).
|
Peak value during landing in both single-leg and double-leg tasks averaged over 3 trials and normalized to the product of body weight and height
|
Separate values prior to and immediately following the intervention (within 5 minutes).
|
|
Internal Knee Extension Moment (KEM)
Tidsram: Separate values prior to and immediately following the intervention (within 5 minutes).
|
Peak value during landing in both single-leg and double-leg tasks averaged over 3 trials and normalized to a product of body weight*height
|
Separate values prior to and immediately following the intervention (within 5 minutes).
|
|
Knee Flexion Angle (KFA)
Tidsram: Separate values prior to and immediately following the intervention (within 5 minutes).
|
Peak value during landing in both single-leg and double-leg tasks averaged over 3 trials
|
Separate values prior to and immediately following the intervention (within 5 minutes).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dynamic Postural Control
Tidsram: Separate values prior to and immediately following the intervention (within 5 minutes).
|
Time-to-stabilization during single-leg landing
|
Separate values prior to and immediately following the intervention (within 5 minutes).
|
|
Vertical Ground Reaction Force
Tidsram: Separate values prior to and immediately following the intervention (within 5 minutes).
|
Peak value during landing in both single-leg and double-leg tasks
|
Separate values prior to and immediately following the intervention (within 5 minutes).
|
|
Frontal Plane Kinematics
Tidsram: Separate values prior to and immediately following the intervention (within 5 minutes).
|
Peak value during landing in both single-leg and double-leg tasks
|
Separate values prior to and immediately following the intervention (within 5 minutes).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Derek Dewig, University of North Carolina, Chapel Hill
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2021
Primärt slutförande (Faktisk)
22 april 2022
Avslutad studie (Faktisk)
10 maj 2022
Studieregistreringsdatum
Först inskickad
10 juni 2026
Först inskickad som uppfyllde QC-kriterierna
25 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 21-0305
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Tidsram för IPD-delning
IPD will be available beginning 9 and continuing for 36 months following publication.
Kriterier för IPD Sharing Access
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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