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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04988828
Other study ID # CREC2019.488
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2021
Est. completion date September 1, 2022

Study information

Verified date August 2021
Source Chinese University of Hong Kong
Contact Jihong QIU, MSc
Phone +85226364171
Email 1155036150@link.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: Approximately 35% patients can not return to sports after anterior cruciate ligament reconstruction(ACLR). Persistent quadriceps weakness is a factor that prevents patients return to sports. Pre-operative quadriceps strength is a predictor for the outcomes after ACLR. Therefore, enhancing pre-operative quadriceps is important. However, current prehabilitation can not well restore quadriceps strength may be due to quadricep inhibition. Whole body vibration was proposed as a promising intervention to increase muscle strength and modulate quadriceps inhibition simultaneously. Therefore, this study aim to investigate if whole body vibration has the efficacy of enhancing pre-operative quadriceps and modulating quadricep inhibition in patients with ACL injuries. Methods: A randomized controlled trial was designed. Patients with primary ACL injuries, age from 18-45 yrs, BMI<29, physically active who awaiting ACLR will be included. Patients with any previous lower-limb injuries within 1 year, any cardiovascular or metabolic disorders will be excluded. All the subjects in this study have to finish their routine 5 week prehabilitation as well as the interventions. The primary outcomes of this study include quadriceps strength and quadriceps central activation ratio. Secondary outcomes include the score of IKDC and ACL-RSI, as well as the concentrations of myokines in serum.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Whole body vibration
vertical vibration platform with the frequency of 30Hz, amplitude of 4mm. The intervention will last for 5 weeks, twice /week.

Locations

Country Name City State
Hong Kong Prince Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary quadriceps strength Subjects' quadriceps peak torque (both legs) measurement will be completed on an isokinetic strength dynamometer (Biodex System 3, Biodex Medical Systems, Shirley, NY, USA). During the test, subjects are positioned with their hip flexed 90°and knee flexed 30°and subjects are asked to try their very best to ensure the MVIC. Meanwhile, the tester will give encouraging word 'harder and harder' during the process of contraction. The MVIC test will repeat 3 times per subject. And sufficient rest is allowed during the interval of each repeat. In order to standardize the data, individual MVIC peak torque will be divided by the body mass of every subject for the further statistic analysis. change from baseline to finishing the intervention
Primary quadriceps central activation ratio he peak torque recorded from the MVIC test will be inputted into a software to deliver a supramaximal electrical stimulus (from DS7R:10-pulses, 100 Hz train) to the quadriceps muscle once the maximal knee extension torque is reached. The electrical stimulus will be delivered through two self-adhesive stimulating electrodes (8 × 13cm) applied over the vastus lateralis muscle proximally and the vastus medialis distally. Quadriceps activation ratio will be calculated using the central activation ratio formula (CAR), which is (MVIC) / (peak torque generated by the stimulus) *100. A CAR of 100 was used to represent complete quadriceps activation. CAR values that were = 95 were considered to be 'normal' and/or representative of a healthy CAR value. The maximal CAR value that is collected will be used for statistical analysis. change from baseline to finishing the intervention
Secondary International Knee Documentation Committee Subjective Knee Form (IKDC) The IKDC is consisted of 10 questions about symptoms and activity ranging from 0 to 100 where 100 implies perfect knee function. change from baseline to finishing the intervention
Secondary Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) The ACL-RSI scale with 12 items measures three specific psychological constructs-emotions, confidence in performance and risk appraisal-on a scale from 0 to 100. In this scale, higher score indicates better psychological readiness of patients to return to sports. change from baseline to finishing the intervention
Secondary International Physical Activity Questionnaire - Short Form (IPAQ) This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. The specific types of activity that are assessed are walking, moderate-intensity activities and vigorous intensity activities; frequency (measured in days per week) and duration (time per day) are collected separately for each specific type of activity. These following values continue to be used for the analysis of IPAQ data: Walking = 3.3 METs, Moderate PA = 4.0. There is no exact range of the IPAQ score. In addition, higher scores mean more active lifestyle and higher intensity of daily activity.
METs and Vigorous PA = 8.0 METs.
Every week during the 5 week interventions
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