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Anterior Cruciate Ligament ReconstructionNCT02609971

Whole Body Vibration in Individuals Submitted to ACL

A study testing Vibration at 50 Hz in people with Anterior Cruciate Ligament Reconstruction, run by Universidade Federal do Rio Grande do Norte.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to analyze the immediate effects of two exercises protocols on the whole body vibration, on the strength of the thigh muscles, joint position sense of the knee and balance in individuals submitted to anterior cruciate ligament reconstruction. Read more about this study

Who is it for?
Ages 18 to 45 years, men only
What is being tested?
Vibration at 50 Hz
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
Feb 2015to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects between the 14th and 18th postoperatory week;
  • Without pain or inflammatory signs in the joint assessed;
  • Absence of labyrinthine and neurological disorders;
  • Range of motion greater than 90o flexion and complete extension;
  • No previous history of lower limb surgery before the lesion;
  • Be performing Physical Therapy

Who cannot join

  • Inability to understand and/or perform the required maneuvers;
  • Presence of pain at the time of the tests;
  • Complication preventing collection.

About this study

Official title: Immediate Effects of Whole Body Vibration on Neuromuscular Performance of Quadriceps Femoris in Individuals Submitted to Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial

The purpose of this study is to analyze the immediate effects of two exercises protocols on the whole body vibration, on the strength of the thigh muscles, joint position sense of the knee and balance in individuals submitted to anterior cruciate ligament reconstruction.

Read the detailed description

This is a randomized and blinded clinical trial held at the Laboratory of Neuromuscular Performance of the Department of Physical Therapy, Federal University of Rio Grande do Norte (UFRN). Characterization of the sample: The sample consisted of 46 men submitted to anterior cruciate ligament reconstruction. The participants were randomly divided into 2 distinct groups. Ethical aspects: For its implementation, this project was submitted to the Research Ethics Committee (REC) of the Federal University of Rio Grande do Norte. Was respected and ensured the autonomy and anonymity of participants, as well as privacy as confidential data, as governed Resolution 196/96 of the National Health Council and the Helsinki declaration for human research. Instruments: Stationary bicycle (Ergo-Fit, ErgoCycle 167, Pirmasens, Germany); computerized baropodometry platform Eclipse 3000 model (Guy-Capron® SA, France); vibrating platform model Power Plate® pro5 ™; signal conditioning module (Telemyo direct transmission system) 8-channel (Noraxon, USA); self-adhesive electrode active surface (Noraxon, USA); isokinetic dynamometer (Biodex Multi-Joint System 4, Biomedical Biodex System Inc.®, New York, USA). Procedures: There was a previous pilot study for adequacy of any research procedures and the training of evaluators. The volunteers were informed about the procedures to be performed in the research, signed the informed consent form, fill in an evaluation form with anthropometric data and personal examination of members. Evaluations were performed before and after the intervention protocol. Initially, all the volunteers executed a warming exercise on a stationary bike for 5 minutes. After that, they were submitted for shaving and cleaning the skin with 70% alcohol before attaching the electrodes on vastus medialis and vastus lateralis. Torque rating: the volunteer was positioned sitting on the dynamometer, stabilized by braces and with the device axis aligned with the knee evaluated. The apparatus of the lever arm was attached to the distal leg. Then, it was performed the normalization of the electromyographic signal, where the subject performed two maximal voluntary isometric contractions of knee extension at an angle of 60 ° for 5s, with one-minute interval between each repetition. After, the concentric evaluation was conducted, with 5 maximal contractions for knee flexion and extension at 60 ° / s, starting from 90 ° flexion up to full extension. Joint position sense: The volunteer was instructed to perform a knee extension member starting with 90 ° of flexion. When the 45 target angle wass reached, the dynamometer arm remained in this position, keeping it for 5 seconds, so that the voluntary noticed which the angle to be achieved. Finally, prompted an active extension from 90 ° knee flexion (1 / s) to the target angle, the second trial of the subject. At that moment, the volunteer should trigger a device to record the angle reached. Postural balance: the volunteers were placed standing on the baropodometry platform, supported in the non-dominant member and with the knee kept at 40 ° of flexion. The affected limb remained with the knee in 90 ° of flexion. The evaluation was repeated 3 times, being considered for analysis the average of the two best measures. The evaluation time was 20 seconds on an acquisition frequency of 20 Hz with a period of 1 minute break between tests. Previously the participant was allowed to become familiar with the equipment. Electromyographic activity: emg was collected concurrently with exercise protocols on the platform, as well as during the torque rating.

Being tested
Vibration at 50 Hz
Keywords
Anterior cruciate ligament, Neuromuscular Performance and balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vibration at 50 HzOther

    During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz.

Study groups in NCT02609971
Study groupRoleWhat they receive
Vibration groupExperimentalThe vibration group (Vibration at 50 Hz) will hold an exercise protocol on the vibration platform (model Power Plate® pro5 ™), which is to stay on on affected limb, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. During the sets the vibrating platform will be turned on at a vibration frequency of 50 Hz.
Receives: Other: Vibration at 50 Hz
Control groupNo interventionThe control group (No vibration) will hold an exercise protocol on the vibration platform, which is to stay on affected limb, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. The vibrating platform will remain off throughout intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle Performance measured through isokinetic dynamometer

    Measured through isokinetic dynamometer. The variable analyzed will be: peak torque normalized by body weight (%).

    Measured: Change from baseline in muscle performance at one hour.

Secondary outcomes (1)
  1. Muscle activation measured through surface electromyography

    Measured by surface electromyography. The variable analyzed will be: RMS (Root Mean Square.

    Measured: Change from baseline in electromyographic activity at one hour.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02609971
Sponsor's protocol ID
07042915KA
Status last verified
Jul 2016
First submitted
16 Nov 2015
Last updated
18 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Vibration at 50 Hz in people with Anterior Cruciate Ligament Reconstruction, run by Universidade Federal do Rio Grande do Norte.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Performance measured through isokinetic dynamometer (time frame: Change from baseline in muscle performance at one hour.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.

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