Neurocognitive Loading Following Anterior Shoulder Stabilization: A Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHacettepe University
About this trial
The goal of this randomized controlled clinical trial is to learn if adding neurocognitive loading to standard shoulder rehabilitation improves physical and psychological recovery in adults who have undergone arthroscopic anterior shoulder stabilization surgery (such as Bankart repair, Latarjet, or remplissage procedures).
The main questions it aims to answer are:
Does adding neurocognitive loading exercises improve shoulder proprioception, muscle strength, and functional performance compared to standard therapy alone? Does this integrated training approach reduce the kinesiophobia? Does it lead to better overall clinical outcomes and improve psychological readiness to return to sports? Researchers will compare a group receiving standard shoulder exercises combined with dual-task neurocognitive loading (using light-based reaction systems and cognitive tasks) to a control group receiving standard shoulder rehabilitation alone. Participants will:Undergo supervised physical therapy sessions starting 10 days after surgery up to the 16th postoperative week (twice a week for the first 12 weeks, and once a week for weeks 13-16) alongside an assigned home exercise program. Complete neurocognitive loading tasks (if assigned to the intervention group) that challenge attention, quick decision-making, and visual reactions while executing physical movements. Attend detailed clinical evaluation sessions lasting about 60 minutes before the treatment starts, and at 6, 12, and 24 weeks after surgery. These assessments include neurocognitive, functional and clinical tests, and questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: Participant must be between 18 and 45 years of age.
Diagnosis: Must have undergone arthroscopic anterior shoulder stabilization surgery (e.g., Bankart repair, Latarjet, or remplissage techniques) within the past month due to traumatic, unilateral anterior shoulder instability.
Postoperative Timeline: Currently within postoperative days 10 to 28.
Baseline Activity Level: Pre-injury physical activity level must be a score of 3 or higher on the Tegner Activity Scale.
Disqualifiers
Hypermobility: Diagnosed generalized joint hypermobility syndrome, defined as a Beighton Score of 5 or higher.
Neurological or Systemic Conditions: Presence of any systemic, rheumatic, or neurological disorders.
Previous Surgical History: History of prior shoulder surgery or revision surgery on the affected side, with the exception of the primary anterior shoulder stabilization and an accompanying SLAP lesion repair.
Concomitant Structural Pathology: Concomitant rotator cuff tear larger than 1 centimeter. History of osteochondral lesions or acromioclavicular separation injuries.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Rehabilitation
Procedure/SurgeryA structured, multi-stage physical exercise protocol adhering to modern clinical guidance for traumatic upper-extremity instability repairs. The protocol spans from postoperative day 10 through the 16th week, comprising supervised clinic sessions (twice weekly for weeks 1-12; once weekly for weeks 13-16) and a 4-day-a-week home routine. The physical program is identically matched for both groups and progresses through standard clinical healing benchmarks: Initial Phase (Days 10-14): Early Mobility \& Activation (Weeks 3-6) Dynamic Control \& Resistance (Weeks 7-12) Advanced Neuromuscular Function (Weeks 13-16) All exercises are limited strictly by the patient's pain boundary (maintaining a Visual Analog Scale score of 3/10). Neurocognitive training group also administers an incremental neurocognitive workload spanning 5 distinct tiers over the rehabilitation timeline.
Neurocognitive Loading
Procedure/SurgeryA wireless, multi-pod reaction light system used to deliver visual-reactive and cognitive stimuli concurrently during shoulder stabilization exercises. While maintaining physical training, patients must use their uninjured limb to tap out specific light prompts according to rules programmed into the system. The system administers an incremental cognitive workload spanning 5 distinct tiers over the rehabilitation timeline: Weeks 3-4: Random single-light triggers to challenge selective attention and basic orientation. Weeks 5-6: Multi-color random triggers requiring response inhibition (hitting target colors while ignoring distractor stimuli). Weeks 7-8: Color-position matching rules requiring spatial-visual processing. Weeks 9-12: Sequential working memory strings and Go/No-Go rules. Weeks 13-16: Multi-layered hiearchical decision conflicts (such as color targets overriding spatial constraints).
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Standard Rehabilitation GroupActive comparator 1 intervention
Group B: Neurocognitive Loading GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Shoulder Joint Proprioception
Evaluated via an active angle reproduction test in the scapular plane (elevations at 40 and 100 degree) and during glenohumeral internal and external rotation (at 90 degree of abduction and 90 degree of flexion). Measurements are captured using a valid smartphone-based digital gonyometer software application (Goniometer Pro) secured to the participant's wrist. Goggles or blindfolds are used to eliminate visual feedback. The score is recorded as the mean absolute error deviation (in degrees) across three trials per target angle, where a lower error score represents superior proprioceptive accuracy.
Time frame
Postoperative Week 12 and Postoperative Week 24.Secondary outcomes
1
Shoulder Joint Proprioception - Force Reproduction Sense
Assesses muscle force production awareness for internal/external rotators and general shoulder musculature using a digital hand-held dynamometer with visual feedback completely eliminated. Participants execute a maximum voluntary isometric contraction (MVIC), followed by a target phase at 50% MVIC held for 8 seconds to anchor force memory. In the subsequent reproduction phase, participants attempt to replicate that exact target force value. The final score is analyzed as the mean absolute force error deviation across three distinct repetitions per test position.
Time frame
Postoperative Week 12 and Postoperative Week 242
Neurocognitive Closed Kinetic Chain Upper Extremity Stability Test
Evaluates combined motor-cognitive performance by introducing a visual decision-making overlay onto a high plank physical test baseline. Utilizing a four-pod reactive light display system (BlazePod) , participants must recognize random color prompts and strike targets using precise limb rules. Performance outputs are quantified via three metrics: total number of accurate hits, average cognitive reaction speed (milliseconds), and total count of incorrect hand choices or missed targets.
Time frame
Postoperative Week 12 and Postoperative Week 243
Neurocognitive Upper Quarter Y-Balance Test
Combines dynamic single-limb balance with explicit visual-spatial differentiation rules. Three reaction pods are configured at a fixed boundary corresponding to $80\\%$ of the participant's baseline unweighted maximum UQYBT reaching limits. When target lighting arrays illuminate in variable color pairings , the patient must discriminate the pre-selected correct hue and execute a rapid reaching displacement to register 9 touches. Performance is scored via average decision reaction latency and total tracking fault count.
Time frame
Postoperative Week 12 and Postoperative Week 244
Muscle Strength
Evaluates maximum isometric force output for shoulder internal rotators, external rotators, and general shoulder elevation in the scapular plane using an EasyForce manual hand-held dynamometer. Participants perform three repetitions of a 5-second maximum voluntary isometric contraction per muscle group. The maximum force value is recorded in Newtons or kilograms, and the internal-to-external rotator strength ratios are calculated symmetrically.
Time frame
Postoperative Week 12 and Postoperative Week 24Locations
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Source ClinicalTrials.gov
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