NCT05581459

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 12, 2022

Last Update Submit

October 12, 2022

Conditions

Keywords

Muscle vibrationjoint position senseproprioceptionelbowrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Active elbow joint position error

    Participants were asked to actively reproduce a target position of the elbow joint.

    1 day

Study Arms (3)

63 Hz vibration group

EXPERIMENTAL

Vibration of 63 Hz frequency was applied.

Other: 63 Hz Vibration

42 Hz vibration group

ACTIVE COMPARATOR

Vibration of 42 Hz frequency was applied.

Other: 42 Hz Vibration

Sham vibration group

SHAM COMPARATOR

No actual vibration was applied.

Other: Sham vibration

Interventions

Vibrations of 63 Hz were applied with handheld vibration device.

63 Hz vibration group

Vibrations of 42 Hz were applied with handheld vibration device.

42 Hz vibration group

Handheld device was applied to the participants without any vibrations.

Sham vibration group

Eligibility Criteria

Age19 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young men

You may not qualify if:

  • history of recent upper extremity surgery
  • history of sensory deficits in the upper extremity
  • recent upper extremity injury
  • undergoing any resistance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

Study Officials

  • Masood Khan, M.P.Th

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 14, 2022

Study Start

June 6, 2018

Primary Completion

September 24, 2018

Study Completion

November 15, 2018

Last Updated

October 14, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations