- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07510893
Augmented Feedback Effects on Shoulder Rotator Performance
Immediate and Retention Effects of Augmented Feedback on Isometric Peak Force and Rate of Force Development of Shoulder Rotators
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All participants will complete a standardized warm-up protocol of approximately 10 minutes prior to the testing sessions. The warm-up will begin with arm circles to promote active mobilization of the shoulder joint. This will be followed by one set of 10 repetitions of shoulder internal and external rotation exercises performed at 90° of shoulder abduction and 90° of elbow flexion using a resistance band providing submaximal resistance. Following the warm-up, a familiarization session will be conducted to increase participants' familiarity with the ForceFrame device used in the testing and training sessions. During this session, participants will perform five repetitions of isometric contractions, each lasting 5 seconds, at a self-selected submaximal effort level. The familiarization session is intended to ensure participants' adaptation to the testing procedure, learning of the correct movement sequence, and execution of the exercise with proper technique. Following completion of the warm-up protocol, isometric muscle strength and rate of force development of the dominant shoulder internal and external rotator muscles will be assessed. All measurements will be performed using an isometric dynamometer (ForceFrame). During testing, participants will be positioned in a supine position with the knees flexed and feet flat on the ground, while the non-tested arm will be placed across the chest.
The tested shoulder will be positioned at 90° of abduction and the elbow at 90° of flexion, with the hand placed at a comfortable height appropriate for pushing against the sensors. The testing protocol will consist of three repetitions of maximal isometric contractions, each lasting 5 seconds, with 20 seconds of rest between repetitions. Maximum force and rate of force development values will be recorded during each trial. Throughout testing, participants will be instructed to maintain the standardized position and keep their arms stable. Prior to each test, standardized verbal instructions will be provided, instructing participants to perform the contractions "by producing maximal force as quickly as possible." The test protocol will be administered at three time points: before the isometric training (pre-test), immediately after the training protocol (post-test), and 15 minutes after training to assess immediate retention (immediate retention test).
Following the pre-test, participants will perform the isometric training protocol targeting the shoulder internal and external rotator muscles. The training protocol will also be conducted using the ForceFrame device. During training, participants will be positioned identically to the testing protocol, in a supine position with the knees flexed and feet flat on the ground, while the non-tested arm will be placed across the chest. The tested shoulder will be positioned at 90° of abduction and the elbow at 90° of flexion. The training protocol will consist of one set of three repetitions, each involving a 5-second isometric contraction, with 20 seconds of rest between repetitions. Throughout the training, participants will be instructed to maintain the standardized position and keep their arms stable. Standardized verbal instructions will be provided to all participants, instructing them to perform the isometric contractions "by producing maximal force as quickly as possible."
Knowledge of results will be provided between repetitions during the training session. Following each repetition, participants will receive immediate quantitative feedback regarding their maximum force (peak force) and rate of force development. The feedback will be delivered by the same physiotherapist to all participants, using a clear and emphatic tone, slightly louder than normal conversational volume to ensure it is distinguishable from background noise.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif Turgut, PhD, PT
- Phone Number: +905442645600
- Email: elif.turgut.pt@gmail.com
Study Locations
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Sıhhıye
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Ankara, Sıhhıye, Turkey (Türkiye), 06100
- Recruiting
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation,
-
Contact:
- Elif Turgut, PhD, PT
- Phone Number: +905442645600
- Email: elif.turgut.pt@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy individuals aged between 18 and 30 years,
- Body Mass Index (BMI) below 30 kg/m²,
- An activity level of 5 or higher according to the Tegner Activity Scale,
- Full active range of motion (ROM) in shoulder flexion, abduction, internal, and external rotation.
Exclusion Criteria:
- Resence of current pain complaints,
- Provocation of symptoms during at least one of the specific shoulder clinical tests (Neer Test, Hawkins-Kennedy Test, Jobe Test, Resisted External Rotation Test, and Apprehension Test),
- History of any upper extremity injury, pain, or surgical intervention within the past 12 months,
- Presence or history of hypertension, cardiovascular diseases, peripheral vascular diseases, deep vein thrombosis, neurological disorders, systemic inflammation, diabetes, cancer, or obesity,
- Unwillingness to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Augmented Feedback
Participants will attend two separate sessions of isometric strength training targeting the dominant shoulder internal and external rotator muscles.
All participants will perform the isometric training program under two different conditions-providing augmented feedback and no feedback-within a randomized cross-over design.
Augmented feedback will be provided during the training between repetitions.
After each repetition, participants will receive immediate quantitative feedback regarding their peak force and rate of force development values.
|
Augmented feedback is a term used to describe information about the performance of a skill provided from an external source.
When this information is presented quantitatively, it is referred to as Knowledge of results (e.g., movement velocity, jump height, or peak force).
Knowledge of results, which is a critical component of performance improvement, is delivered to athletes through professional coaching staff as well as advanced technological applications.
Accordingly, research in this area has focused on the pivotal role of real-time data flow and feedback in optimizing performance.
|
|
No Intervention: Non-Feedback
Participants in the non-feedback condition will perform the standard isometric strength training protocol targeting the dominant shoulder internal and external rotator muscles.
During this condition, participants will not receive any quantitative or augmented feedback regarding their peak force or rate of force development values.
They will be instructed to perform the exercises with maximal effort based solely on standard verbal instructions, without access to any real-time performance data from the testing device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Force
Time Frame: Within the same intervention day: Baseline, immediately post-intervention, and 15 minutes post-intervention
|
Peak force refers to the maximum force generated by the shoulder internal or external rotator muscles during a single maximal isometric contraction.
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Within the same intervention day: Baseline, immediately post-intervention, and 15 minutes post-intervention
|
|
Rate of Force Development
Time Frame: Within the same intervention day: Baseline, immediately post-intervention, and 15 minutes post-intervention
|
Rate of Force Development efers to the speed at which force is generated by the shoulder internal or external rotator muscles during a maximal isometric contraction.
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Within the same intervention day: Baseline, immediately post-intervention, and 15 minutes post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Chalker WJ,Shield AJ,Opar DA,Rathbone EN,Keogh JWL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FTREK26/30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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