Vibration; ExposureNCT05581459
Muscle Vibration and Joint Position Sense
A study testing 63 Hz Vibration and 42 Hz Vibration in people with Vibration; Exposure, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The present study aimed to investigate and compare the acute effect of local vibration (63 Hz vs 42 Hz frequencies) on the biceps brachii muscles on the elbow joint position sense (JPS) in healthy young men. Forty-five healthy young men aged 19 to 30 years were enrolled in the study. Read more about this study
- Who is it for?
- Ages 19 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vibration; Exposure
- What is being tested?
- 63 Hz Vibration and 42 Hz Vibration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Jun 2018to 15 Nov 2018
- 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 19 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men
Who cannot join
- history of recent upper extremity surgery
- history of sensory deficits in the upper extremity
- recent upper extremity injury
- undergoing any resistance training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Muscle Vibration on the Elbow Joint Position Sense in Healthy Young Men
The present study aimed to investigate and compare the acute effect of local vibration (63 Hz vs 42 Hz frequencies) on the biceps brachii muscles on the elbow joint position sense (JPS) in healthy young men. Forty-five healthy young men aged 19 to 30 years were enrolled in the study. The participants were randomly assigned to receive either 63 Hz (n=15) or 42 Hz (n=15) or sham vibration (control group) (n=15). Participants in the experimental group received five bouts of 1-minute of each vibration exposure localized to the biceps brachii muscle, with a 1-minute rest between the bouts. Active elbow joint position error (in degrees) was selected as an outcome measure to assess elbow JPS. To measure active elbow joint position error, the subject was made to sit on the chair with eyes closed and shoulders in 0 degree of abduction and elbows fully extended. The examiner passively moved the elbow to 90 degrees of flexion (target position) and maintained it for 10 seconds. The subject was requested to memorize the target position. The subject was asked to actively flex the elbow to the target position from the initial starting position (elbow fully extended) and hold it for 5 seconds. Three trials were conducted, with a 30-second rest given between each trial. The target and reproduced angles in each trial were measured using a standard plastic goniometer. The difference between the target and reproduced angles in each trial was calculated to determine active elbow joint position error. Measurements were taken at baseline and immediately after the vibration protocol.
- Conditions
- Vibration; Exposure
- Being tested
- 63 Hz Vibration, 42 Hz Vibration, Sham vibration
- Keywords
- Muscle vibration, joint position sense, proprioception, elbow, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
63 Hz VibrationOther
Vibrations of 63 Hz were applied with handheld vibration device.
42 Hz VibrationOther
Vibrations of 42 Hz were applied with handheld vibration device.
Sham vibrationOther
Handheld device was applied to the participants without any vibrations.
| Study group | Role | What they receive |
|---|---|---|
| 63 Hz vibration group | Experimental | Vibration of 63 Hz frequency was applied. Receives: Other: 63 Hz Vibration |
| 42 Hz vibration group | Active comparator | Vibration of 42 Hz frequency was applied. Receives: Other: 42 Hz Vibration |
| Sham vibration group | Sham comparator | No actual vibration was applied. Receives: Other: Sham vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active elbow joint position error
Participants were asked to actively reproduce a target position of the elbow joint.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start6 Jun 2018
- Primary completion24 Sep 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vibration; ExposureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581459
- Sponsor's protocol ID
- RRC-2018-007
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Muscle Vibration on the Elbow Joint Position Sense in Healthy Young Men
- ClinicalTrials.gov ID
- NCT05581459
- Acronym / sponsor ID
- RRC-2018-007
- Conditions
- Vibration; Exposure
- Keywords
- Muscle vibration, joint position sense, proprioception, elbow, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 14 Oct 2022 (actual)
- 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.
The present study aimed to investigate and compare the acute effect of local vibration (63 Hz vs 42 Hz frequencies) on the biceps brachii muscles on the elbow joint position sense (JPS) in healthy young men. Forty-five healthy young men aged 19 to 30 years were enrolled in the study. The participants were randomly assigned to receive either 63 Hz (n=15) or 42 Hz (n=15) or sham vibration (control group) (n=15). Participants in the experimental group received five bouts of 1-minute of each vibration exposure localized to the biceps brachii muscle, with a 1-minute rest between the bouts. Active elbow joint position error (in degrees) was selected as an outcome measure to assess elbow JPS. To measure active elbow joint position error, the subject was made to sit on the chair with eyes closed and shoulders in 0 degree of abduction and elbows fully extended. The examiner passively moved the elbow to 90 degrees of flexion (target position) and maintained it for 10 seconds. The subject was requested to memorize the target position. The subject was asked to actively flex the elbow to the target position from the initial starting position (elbow fully extended) and hold it for 5 seconds. Three trials were conducted, with a 30-second rest given between each trial. The target and reproduced angles in each trial were measured using a standard plastic goniometer. The difference between the target and reproduced angles in each trial was calculated to determine active elbow joint position error. Measurements were taken at baseline and immediately after the vibration protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 63 Hz vibration group | Experimental | Other: 63 Hz VibrationVibration of 63 Hz frequency was applied. |
| 42 Hz vibration group | Active comparator | Other: 42 Hz VibrationVibration of 42 Hz frequency was applied. |
| Sham vibration group | Sham comparator | Other: Sham vibrationNo actual vibration was applied. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young men
Key exclusion criteria (4 listed)
- history of recent upper extremity surgery
- history of sensory deficits in the upper extremity
- recent upper extremity injury
- undergoing any resistance training
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 |
|---|---|---|
| 63 Hz VibrationVibrations of 63 Hz were applied with handheld vibration device. | Other | 63 Hz vibration group |
| 42 Hz VibrationVibrations of 42 Hz were applied with handheld vibration device. | Other | 42 Hz vibration group |
| Sham vibrationHandheld device was applied to the participants without any vibrations. | Other | Sham vibration group |
Primary outcome
Active elbow joint position error
Time frame: 1 day
Participants were asked to actively reproduce a target position of the elbow joint.
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 14 Oct 2022.
- 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.
Masood Khan, M.P.Th principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 63 Hz Vibration and 42 Hz Vibration in people with Vibration; Exposure, run by King Saud University at 1 site in Saudi Arabia.
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 1 inclusion and 4 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 14 Oct 2022. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
Active elbow joint position error (time frame: 1 day). 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 14 Oct 2022.