- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06910332
The Effect of Shoulder Mobilization on Muscle Strength and Proprioception: a Randomized Double-blind Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Summary of the Study
This randomized, double-blind study investigates the acute effects of shoulder joint mobilization on muscle strength and proprioception in healthy individuals compared to a sham intervention.
Background:
The shoulder joint is highly mobile and prone to injury, with rehabilitation often including manual therapy techniques like joint mobilization. Mobilization may enhance joint stability, neuromuscular control, and proprioception by stimulating mechanoreceptors. However, its immediate effects on shoulder proprioception and strength remain unclear.
Methods:
Participants: 48 healthy university students (aged 18-25) randomly assigned to either the mobilization or sham group.
Assessments: Muscle strength (using a handheld dynamometer) and proprioception (laser pointer-assisted joint position reproduction test) were measured before and after the intervention.
Intervention: The mobilization group received passive shoulder joint glides, while the sham group underwent a placebo procedure without actual joint movement.
Conclusion:
This study aims to determine whether shoulder mobilization has immediate effects on proprioception and strength.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
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Ataşehir, Istanbul, Turkey (Türkiye), 34752
- Acıbadem University Kerem Aydınlar Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy university students aged 18-25 years.
Exclusion Criteria:
- Individuals with orthopedic problems in the shoulder complex.
- Those who have undergone previous shoulder surgery.
- Participants with prior knowledge of joint mobilization techniques that could affect the sham intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobilization Group
Participants receive passive shoulder joint mobilization targeting the glenohumeral joint.
|
Participants receive passive shoulder joint mobilization on the dominant-side glenohumeral joint.
The mobilization includes inferior, anterior, and posterior glide techniques, each performed for 1 minute at a frequency of 0.5 Hz, with a 30-second rest between each mobilization.
The participant is positioned comfortably to support the joint's range of motion.
Other Names:
|
|
Sham Comparator: Sham Group
Participants undergo a placebo procedure where the practitioner mimics the mobilization technique without applying actual joint movement or distraction.
|
In the sham intervention, the practitioner mimics the technique of shoulder mobilization but does not apply any actual movement or glide effect on the joint.
The procedure is designed to closely resemble the real intervention in terms of duration, rhythm, and the practitioner's handling of the participant's shoulder.
The practitioner will use superficial touch on the glenohumeral joint without applying any of the mobilizing forces necessary to move the joint.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proprioception
Time Frame: Before the intervention
|
Laser pointer-assisted joint position reproduction test for shoulder: A laser pointer is strapped 5 cm above the lateral epicondyle. Participants actively move their arm to a predefined position (90° flexion or abduction), and the laser projection is marked. After lowering their arm and closing their eyes, they attempt to replicate the same position. The difference between the initial and reproduced positions (in millimeters) is measured |
Before the intervention
|
|
Proprioception
Time Frame: Immediately after intervention
|
Laser pointer-assisted joint position reproduction test for shoulder: A laser pointer is strapped 5 cm above the lateral epicondyle. Participants actively move their arm to a predefined position (90° flexion or abduction), and the laser projection is marked. After lowering their arm and closing their eyes, they attempt to replicate the same position. The difference between the initial and reproduced positions (in millimeters) is measured |
Immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: Before the intervention
|
Hand-held dynamometer (Lafayette) Muscle strength will be measured using a hand-held dynamometer (Lafayette).
The assessment will focus on the shoulder flexors, abductors, internal rotators, and external rotators.
Three measurements for each muscle group will be taken, and the average value will be recorded in kilograms (kg).
|
Before the intervention
|
|
Muscle Strength
Time Frame: Immediately after intervention
|
Hand-held dynamometer (Lafayette) Muscle strength will be measured using a hand-held dynamometer (Lafayette).
The assessment will focus on the shoulder flexors, abductors, internal rotators, and external rotators.
Three measurements for each muscle group will be taken, and the average value will be recorded in kilograms (kg).
|
Immediately after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACU-FTR-AOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Demographic Data:
Age and gender,
Outcome Measures Data:
Muscle strength values recorded using the hand-held dynamometer for each muscle group (shoulder flexors, abductors, internal rotators, external rotators).
Proprioception data measured by the laser pointer-assisted joint position reproduction test, including the distance (in millimeters) between the initial and reproduced positions for both shoulder flexion and abduction.
Group Assignment Data:
Whether the participant was assigned to the mobilization group or the sham intervention group.
Intervention Data:
Details of the intervention received, including whether they underwent shoulder mobilization or placebo procedure.
Timing of Measurements:
Pre- and post-intervention data for both muscle strength and proprioception assessments.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Who Can Access:
- Researchers, academics, and institutional partners with a legitimate research purpose.
- Regulatory agencies or health organizations.
What They Can Access:
- Anonymized IPD (muscle strength, proprioception, demographics).
- Supporting information (study protocol, SAP,)
How They Can Access:
- Data will be shared upon contact with the study team.
- Interested parties must request access, and data will be provided following review and approval.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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