Knee OsteoarthritisNCT02851316
Whole Body Vibration on Running Biomechanics
A study testing Whole Body Vibration in people with Knee Osteoarthritis, run by California State University, Fullerton at 1 site in United States.
Trial summary
Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is unclear if WBV influences athletic tasks such as running. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Whole Body Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2017
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-35 years
- Unilateral ACL reconstruction
- At least 6 months post-reconstruction
- Recreationally active (at least 20 minutes of physical activity 3 times per week)
Who cannot join
- History of ACL graft rupture or revision surgery
- Neurological disorder
- Other lower extremity within the 6 months prior to participation
Trial locations and contacts
1 site in 1 country.
United States1 site
CSU Fullerton: Biomechanics Laboratory (KHS 021)
Fullerton, California, 92831
About this study
Official title: The Effect of Whole Body Vibration on Running Biomechanics in Individuals With Anterior Cruciate Ligament Reconstruction
Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is unclear if WBV influences athletic tasks such as running. The purpose of this study is to evaluate the influence of WBV on running biomechanics in individuals with ACLR.
Read the detailed description
Individuals with anterior cruciate ligament reconstruction (ACLR) have deficits in quadriceps muscles function that influences walking and running biomechanics. In the long term, alterations in walking and running contribute to physical disability and the development of knee osteoarthritis. Unfortunately, rehabilitation for the quadriceps muscles is often ineffective, and novel strategies to improve rehabilitation efforts are needed. Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with ACLR. However, it is unclear if WBV influences athletic tasks such as running.
Specific Aim 1: The purpose of this study is to determine the effect of WBV on running biomechanics in individuals with ACLR. The investigators hypothesize that WBV will improve running characteristics associated with knee osteoarthritis development.
- Conditions
- Knee Osteoarthritis
- Being tested
- Whole Body Vibration
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body VibrationOther
Participants will stand in a squatted position on a platform that provides a brief vibratory stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration | Experimental | The WBV intervention consists of 6 bouts of 60 seconds vibration with 2 minutes of rest in between (30Hz, 2g acceleration) while participants stand on a vibrating platform with their knees bent. Receives: Other: Whole Body Vibration |
| Control | No intervention | The control intervention consists of 6 bouts of 60 seconds with 2 minutes of rest in between while participants stand with their knees bent (no vibration applied). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ground reaction force
Ground reaction force during running gait
Measured: Day 1, Prior to and immediately following vibration intervention in a single session (i.e. - acute effects)
Change in ground reaction force loading rate
Ground reaction force loading rate during running gait
Measured: Day 1, Prior to and immediately following vibration intervention in a single session (i.e. acute effects)
Change in knee flexion excursion
Knee flexion excursion during running gait
Measured: Day 1, Prior to and immediately following vibration intervention in a single session (i.e. acute effects)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, Fullerton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Pamukoff, California State University, Fullerton
- Investigators
- Derek N Pamukoff, PhD, Principal investigator, California State University, Fullerton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851316
- Sponsor's protocol ID
- CSUFullerton
- Status last verified
- Aug 2019
- First submitted
- 19 Jul 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pamukoff DN, Montgomery MM, Choe KH, Moffit TJ, Vakula MN. Effect of Whole-Body Vibration on Sagittal Plane Running Mechanics in Individuals With Anterior Cruciate Ligament Reconstruction: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 May;99(5):973-980. doi: 10.1016/j.apmr.2017.11.019. Epub 2018 Jan 31.
PubMed 29407520
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration on Running Biomechanics in Individuals With Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02851316
- Acronym / sponsor ID
- CSUFullerton
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- California State University, FullertonUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is unclear if WBV influences athletic tasks such as running. The purpose of this study is to evaluate the influence of WBV on running biomechanics in individuals with ACLR.
Detailed description
Individuals with anterior cruciate ligament reconstruction (ACLR) have deficits in quadriceps muscles function that influences walking and running biomechanics. In the long term, alterations in walking and running contribute to physical disability and the development of knee osteoarthritis. Unfortunately, rehabilitation for the quadriceps muscles is often ineffective, and novel strategies to improve rehabilitation efforts are needed. Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with ACLR. However, it is unclear if WBV influences athletic tasks such as running.
Specific Aim 1: The purpose of this study is to determine the effect of WBV on running biomechanics in individuals with ACLR. The investigators hypothesize that WBV will improve running characteristics associated with knee osteoarthritis development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration | Experimental | Other: Whole Body VibrationThe WBV intervention consists of 6 bouts of 60 seconds vibration with 2 minutes of rest in between (30Hz, 2g acceleration) while participants stand on a vibrating platform with their knees bent. |
| Control | No intervention | –The control intervention consists of 6 bouts of 60 seconds with 2 minutes of rest in between while participants stand with their knees bent (no vibration applied). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-35 years
- Unilateral ACL reconstruction
- At least 6 months post-reconstruction
- Recreationally active (at least 20 minutes of physical activity 3 times per week)
Key exclusion criteria (3 listed)
- History of ACL graft rupture or revision surgery
- Neurological disorder
- Other lower extremity within the 6 months prior to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body VibrationParticipants will stand in a squatted position on a platform that provides a brief vibratory stimuli. | Other | Whole Body Vibration |
Primary outcome
Change in ground reaction force
Time frame: Day 1, Prior to and immediately following vibration intervention in a single session (i.e. - acute effects)
Ground reaction force during running gait
Change in ground reaction force loading rate
Time frame: Day 1, Prior to and immediately following vibration intervention in a single session (i.e. acute effects)
Ground reaction force loading rate during running gait
Change in knee flexion excursion
Time frame: Day 1, Prior to and immediately following vibration intervention in a single session (i.e. acute effects)
Knee flexion excursion during running gait
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 29407520Pamukoff DN, Montgomery MM, Choe KH, Moffit TJ, Vakula MN. Effect of Whole-Body Vibration on Sagittal Plane Running Mechanics in Individuals With Anterior Cruciate Ligament Reconstruction: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 May;99(5):973-980. doi: 10.1016/j.apmr.2017.11.019. Epub 2018 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek N Pamukoff, PhD principal investigator
California State University, Fullerton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Body Vibration in people with Knee Osteoarthritis, run by California State University, Fullerton at 1 site in United States.
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 4 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in ground reaction force (time frame: Day 1, Prior to and immediately following vibration intervention in a single session (i.e. - acute effects)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851316, which also lists 1 linked publication.
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 15 Aug 2019.