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Anterior Shoulder DislocationNCT06752551

Apprehension-based Training Compared With Standard Physical Therapy for Military Personnel Following Anterior Shoulder Dislocation - a Randomized Clinical Trial

A study testing Apprehension-based training and Standard physical therapy in people with Anterior Shoulder Dislocation, run by Alon Rabin at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to determine if a new rehabilitation protocol (apprehension-based training), leads to better recovery after shoulder dislocation among military personnel. Participants will be randomly allocated to apprehension-based training or standard physical therapy. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Anterior Shoulder Dislocation
What is being tested?
Apprehension-based training and Standard physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteIsrael
Study dates
5 Feb 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18-39 years
  • Shoulder dislocation (primary or recurrent) documented by a medical practitioner (physician, military medic)
  • Positive anterior apprehension test
  • Gross shoulder muscle strength 3/5 or greater

Who cannot join

  • Previous shoulder fracture, tendon tear, or shoulder surgery
  • Voluntary shoulder dislocation
  • Functional (Stanmore polar III) shoulder instability
  • Dislocation associated with a motor vehicle accident.
  • Diagnosis of rheumatoid arthritis, cancer (current), fibromyalgia, psychiatric disease)
  • Current pregnancy
  • Inability to attend at least one physical therapy session every 2 weeks.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alon Rabin, PhD, DPT contact

972-52-3581550

alonra@ariel.ac.il

Netanel Hollander, MS, PT contact

972-52-9216908

netanel911@gmail.com

Israel1 site, 1 recruiting
  • Israel Defense Forces Medical Corps

    Be’er Ya‘aqov, 7030732

    Netanel Hollander, MS, PT, 972-52-9216908, netanel911@gmail.com

    Alon Rabin, PhD, DPT, 972-52-3581550, alonra@ariel.ac.il

    Recruiting

Other trials in Israel

About this study

Official title: Apprehension-based Training Compared With Standard Physical Therapy Among Military Personnel Following Anterior Shoulder Dislocation

The goal of this clinical trial is to determine if a new rehabilitation protocol (apprehension-based training), leads to better recovery after shoulder dislocation among military personnel.

Participants will be randomly allocated to apprehension-based training or standard physical therapy. In apprehension-based training participants will train to control their shoulder under progressively more unstable conditions. Standard physical therapy will be provided based on the clinical judgment of the treating physical therapist The primary hypothesis is that participants undergoing apprehension-based training will experience a more complete recovery of function, better shoulder-related quality of life, and incur less recurrent dislocations.

Being tested
Apprehension-based training, Standard physical therapy
Keywords
Randomized clinical trial, Anterior shoulder dislocation, Shoulder instability, Physical therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apprehension-based trainingBehavioural

    This intervention is comprised of the 3 phases:

    Static phase - Isometric (static) exercises performed in progressively greater shoulder apprehension ("instability") provoking conditions Dynamic phase: Isotonic (dynamic) exercises using shoulder apprehension-provoking movement patterns at a gradually increasing pace of movement.

    Neurocognitive phase: Dynamic phase exercises are continued at a high pace with the addition of cognitive tasks ("distractions").

    The intervention is guided by a physical therapist and includes up to 8 individual (one on one) sessions. In each session the physical therapist assesses exercise performance quality and when appropriate progresses exercise intensity and/or phase. Patients are expected to perform home exercises according to their phase of the program on a daily basis in between physical therapy sessions.

  • Standard physical therapyBehavioural

    Standard physical will be provided based on the assessment and judgment of the physical therapist. Intervention may include active exercises for increased shoulder mobility, muscle strength and neuromuscular control. Intervention may also include manual therapies such as massage, soft-tissue and joint mobilizations, dry needling, and electrophysiological modalities. No more than 8 individual sessions with a physical therapist will be provided over the course of treatment with some form of a home exercise program in between.

Study groups in NCT06752551
Study groupRoleWhat they receive
Apprehension-based trainingExperimentalApprehension-based training is a 3-phase exercise intervention intended to expose patients to progressively increased shoulder apprehension-provoking conditions. Patients progress from one phase to the other upon completion of the previous level of exercise
Receives: Behavioral: Apprehension-based training
Standard physical therapyActive comparatorStandard physical therapy will be provided by a licensed physical therapist and may include exercises of different kinds, manual therapy, dry needling or electrophysiological modalities.
Receives: Behavioral: Standard physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Return to preinjury level of function

    Patient's ability to resume their preinjury military and overall level of function will be assessed separately through a telephone interview 3 months after the end of their assigned intervention. This outcome will be rated dichotomously: "Yes" (have resumed my preinjury military/overall level of function), or "No" (have not been able to resume my preinjury military/overall level of function).

    Measured: 3 months following the end of intervention

  2. Western Ontario Shoulder Instability Index

    The Western Ontario Shoulder Instability Index is a self-reported measure of shoulder instability related quality of life. This questionnaire includes 21 items regarding symptoms, activity limitations, quality of life and emotions. Each item is scored on a 100mm visual analogue scale resulting in a total score of 0 - 2100 which can be converted to a percentage with greater scores indicating greater disability.

    Measured: Baseline to end of intervention (10 weeks) and 1-year follow-up (62 weeks).

  3. Recurrence

    Recurrent events of instability, either in the form of a frank dislocation or a sensation of instability (subluxation) will be assessed through a telephone interview.

    Measured: One year following the end of the intervention

  4. Supine moving apprehension test

    Dynamic stability will be assessed with the supine moving apprehension test. This is a functional performance test in which the patient is asked to repeatedly move the shoulder into 135- and 180-degrees of abduction from a supine position while holding a dumbbell (2-3 kg). The number of repetitions over one minute comprises the score of the test.

    Measured: Baseline to end of intervention (10 weeks)

Secondary outcomes (6)
  1. Subjective shoulder value

    A patient reported single numeric assessment of shoulder function as a percent of a normal shoulder: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"

    Measured: Baseline, end of intervention (10 weeks), and 1-year follow up (62 weeks)

  2. Tampa scale of kinesiophobia

    A self-reported 17-item fear of movement and reinjury measure. Each item is scored on a 4-point Likert scale for a total score between 17-68.

    Measured: Baseline, end of intervention (10 weeks), and 1-year follow-up (62 weeks)

  3. Anterior apprehension test

    The sensation of apprehension will be assessed through the anterior apprehension test performed in 4 stages: 1.) shoulder abduction to 90 degrees; 2.) external rotation; 3.) horizontal abduction; 4.) Shoulder abduction beyond 90 degrees. Elicitation of apprehension (verbal, fascial expression, or muscle guarding) will be rated according to the stage at which it occurs (1-4). The test will be rated negative (5) if apprehension is not elicited at any stage.

    Measured: Baseline to end of intervention (10 weeks)

  4. Shoulder internal/external rotator muscle strength

    Shoulder internal and external rotator muscle strength will be assessed using a hand-held dynamometer in a supine-lying position with the shoulder abducted 90 degrees, neutral rotation, and the elbow bent 90 degrees. The examiner will position a hand-held dynamometer over the distal anterior (internal rotator strength) or posterior (external rotator strength) aspect of the forearm and resist a maximal voluntary effort by the patient. two repetitions will be performed for each strength test with the highest value used for data analysis.

    Measured: Baseline and end of intervention (10 weeks)

  5. Abdominal rollout

    From a kneeling position with the hands gripping a barbell loaded with a 5kg plate on each side, the patient will roll forward to the greatest distance possible and return to the starting position. The test will be performed in a narrow (shoulder width) and wide (2x shoulder width) hand grip. Up to 5 repetitions will be allowed to achieve maximum distance in each grip condition.

    Measured: Baseline and end of intervention (10 weeks)

  6. Heart rate variability

    Heart rate variability (HRV) during apprehension provocative and non-apprehension provocative shoulder movements will be measured using a Polar H10 chest strap. Heart rate variability will serve a physiological marker for autonomic nervous system response to movement provoked stress in the context of anterior shoulder dislocation.

    Measured: Baseline and end of intervention (10 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2024
  2. Study start5 Feb 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Parallel groups
Model description
Randomized controlled trial: Study intervention: apprehension-based training Control intervention: standard physical therapy
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06752551
Sponsor's protocol ID
2388-2023
Status last verified
Jun 2025
First submitted
22 Dec 2024
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Baseline, final and follow-up self-reported and physical performance outcome measures will be shared electronically.

Publications

  • Rabin A, Noyman L, Yaakobi N, Kazum E. Apprehension-Based Training: A Novel Treatment Concept for Anterior Shoulder Dislocation - A Case Report. Int J Sports Phys Ther. 2024 Jul 1;19(7):888-897. doi: 10.26603/001c.118928. eCollection 2024.

    PubMed 38966825
  • Rabin A, Chechik O, Olds MK, Uhl TL, Kazum E, Deutsch A, Citron E, Cohen T, Dolkart O, Bibas A, Maman E. The supine moving apprehension test-Reliability and validity among healthy individuals and patients with anterior shoulder instability. Shoulder Elbow. 2024 Feb;16(1):98-105. doi: 10.1177/17585732231170197. Epub 2023 Apr 18.

    PubMed 38435037

Questions about this trial

What is this clinical trial studying?

A study testing Apprehension-based training and Standard physical therapy in people with Anterior Shoulder Dislocation, run by Alon Rabin at 1 site in Israel.

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 7 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. 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 Israel. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alon Rabin, PhD, DPT (972-52-3581550, alonra@ariel.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return to preinjury level of function (time frame: 3 months following the end of intervention). The study lists 4 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 NCT06752551, which also lists 2 linked publications.

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 4 Jun 2025.

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