Neurocognitive Loading Following Anterior Shoulder Stabilization: A Randomized Controlled Trial

Effects of Neurocognitive Loading on Neuromuscular Control, Kinesiophobia, and Clinical Outcomes Following Anterior Shoulder Stabilization Surgery: A Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Joint Instability; Postoperative Care; Shoulder Instability
• Intervention / Treatment: Procedure: Standard Rehabilitation; Procedure: Neurocognitive Loading

Detailed Description

Background and Rationale Traumatic anterior shoulder dislocation frequently compromises mechanical tissue stability and alters the sensorimotor pathways by damaging mechanoreceptors and articular proprioceptors. While surgical stabilization methods (e.g., arthroscopic Bankart repair, Latarjet, or remplissage techniques) restore structural integrity, residual deficits in glenohumeral proprioception and neuromuscular rotator cuff control often persist long after surgery. Standard postoperative rehabilitation paradigms primarily emphasize repetitive, single-task motor exercises in highly predictable clinical settings. However, when patients transition back to real-world environments or competitive sports where cognitive and visual demands are high, optimal motor control can fail, escalating the risk of re-injury.

This study utilizes an innovative neurocognitive rehabilitation model designed to bridge the gap between isolated motor performance and complex real-world demands. By adding dual-task training that pairs motor stabilization exercises with explicit cognitive and visual-reactive tasks, this intervention aims to optimize neural resource allocation, enhance motor learning retention, and accelerate safe return-to-sport preparation.

Randomization and Stratification Participants are assessed at the 10th postoperative day and randomly assigned via sequentially numbered, opaque, sealed envelopes to either the experimental group (Neurocognitive Loading) or the control group (Standard Shoulder Rehabilitation). Randomization is stratified based on biological sex and the specific surgical technique used by the orthopedic surgeon to ensure balanced group distributions.

Rehabilitation Framework Both groups undergo an aligned, progressive exercise protocol structured into specific postoperative phases. Following 10 days of absolute joint immobilization, supervised treatment sessions are conducted twice weekly for the first 12 weeks, and once weekly from weeks 13 through 16, supplemented by a structured 4-day-a-week home exercise program. Progression within the physical therapy timeline balances tissue healing constraints with the incremental advancement of mechanical load, moving from passive and active-assisted range of motion to targeted rotator cuff strengthening and scapular stabilization.

Neurocognitive Progression Model

The experimental group executes the exact same physical protocol as the control group but integrates simultaneous neurocognitive loading during all proprioceptive and dynamic stabilization exercises. The cognitive load is applied via a multi-pod wireless reaction light system (BlazePod) and structured cognitive tasks using the healthy, uninjured limb to interact with the stimuli. The progression of the cognitive workload is directly mapped to Aleksandr Luria's "Functional Units of the Brain" model and the Fitts & Posner motor learning stages to systematically shift neurological processing from primitive attention to higher-order executive functioning:

Weeks 3-4 (Cognitive Stage / Unit I - Arousal & Selective Attention): Focuses on basic visual-reactive triggers. Participants respond to a single random light pod to reinforce alert orientation and basic motor planning.

Weeks 5-6 (Associative Stage / Unit II - Information Processing & Inhibition): Introduces selective multi-color triggers. Participants are instructed to react strictly to a designated target color while actively ignoring a distractor color (Response Inhibition).

Weeks 7-8 (Associative Stage / Unit II - Visuospatial Mapping): Integrates color-position rules where participants must process the physical location of the stimulus and match it to an abstract response rule.

Weeks 9-12 (Transition to Autonomous Stage / Unit III - Working Memory & Go/No-Go Executive Processing): Incorporates sequential memory strings (reproducing a multi-pod lighting pattern in correct serial order) and rapid executive Go/No-Go switching rules.

Weeks 13-16 (Autonomous Stage / Unit III - Complex Cognitive Conflict Resolution): Focuses on high-tier hierarchical decisions under environmental conflict (e.g., instructions requiring a response to a specific target color unless it appears in a forbidden physical zone) to simulate complex athletic scenarios.

Progress Management Rules

To safeguard healing tissues and manage neurological adaptation, progression is strictly monitored. Exercises are adjusted using explicit performance error metrics:

Optimal Progression: Achieving a cognitive/motor task accuracy rate of age 80% with only 1 to 2 minor coordination faults justifies advancing the exercise difficulty.

Regressive Calibration: Committing 3> coordination faults or demonstrating a single severe compensatory movement failure requires an immediate step down to a simpler stimulus level (e.g., reducing lighting colors, slowing target velocity, or stabilizing the physical support base).

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elif Turgut, Professor; Phone Number: +905426582390; Email: elif.turgut.pt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Consent: Participant must be willing and give voluntary informed consent to participate in the study.

Exclusion Criteria:

• 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.
• Contralateral Limb Status: History of shoulder instability, shoulder surgery, or any shoulder injury within the past 6 months on the uninjured (contralateral) side.
• Cognitive Impairment: A score of 24 or below on the Standardized Mini-Mental State Examination (MMSE).
• Visual/Sensory Impairments: Any severe visual or sensory deficit that prevents interaction with visual-reactive training equipment.
• Pregnancy: Current pregnancy.

Non-compliance/Withdrawal:

• Refusal to participate or withdrawal of consent at any stage of the study.
• Attendance of less than 80% of the scheduled supervised rehabilitation sessions.
• Missing two consecutive clinical follow-up assessment sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Rehabilitation Group; Participants in this arm receive the exact same progressive standard postoperative shoulder rehabilitation protocol without any neurocognitive loading. Supervised physical therapy sessions are conducted under professional guidance twice weekly during postoperative weeks 1 to 12, and once weekly during weeks 13 to 16, supplemented by a 4-day-a-week home exercise program. The structured multi-phase physical program strictly adheres to established post-surgical stabilization guidelines. Exercises are advanced based on standard clinical tissue healing timelines, shifting from initial joint protection to passive/active-assisted motion, isolated isometric rotator cuff strengthening, progressive resistance band training, scapular control drills, and single-task closed/open kinetic chain neuromuscular stabilization exercises using tools like laser guidance, balance pads, and perturbation devices.	Procedure: Standard Rehabilitation; A 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.
Experimental: Neurocognitive Loading Group; Participants in this arm receive standard shoulder rehabilitation combined with integrated dual-task neurocognitive loading exercises. Supervised physiotherapy sessions are conducted twice weekly during postoperative weeks 1 to 12, and once weekly during weeks 13 to 16, combined with a 4-day-a-week home exercise program. During all shoulder proprioception and dynamic stabilization exercises, an explicit motor or cognitive dual-task is superimposed using a wireless multi-pod reaction light system (BlazePod). The uninjured upper limb is utilized to interact with the cognitive stimuli. The cognitive workload is systematically progressed across the rehabilitation timeline (moving from simple reaction and selective attention to complex working memory strings, Go/No-Go response inhibition, and hiearchical cognitive conflict resolution tasks) based on motor learning stages. Progression is regulated using a standardized performance-error metric ($\ge 80\%$ accuracy required to advance).	Procedure: Standard Rehabilitation; A 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.; Procedure: Neurocognitive Loading; A 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative Week 12 and Postoperative Week 24.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative Week 12 and Postoperative Week 24
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.	Postoperative Week 12 and Postoperative Week 24
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.	Postoperative Week 12 and Postoperative Week 24
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.	Postoperative Week 12 and Postoperative Week 24
Time to Peak Torque	Calculated during the isometric strength testing protocol utilizing the EasyForce hand-held dynamometer software. This metric quantifies the explosive neuromuscular activation capacity by measuring the exact duration (in seconds or milliseconds) required for the participant to reach maximum peak torque from the onset of voluntary contraction.	Postoperative Week 12 and Postoperative Week 24
Closed Kinetic Chain Stability	Participants assume a traditional plank position with hands positioned exactly shoulder-width apart. Within a fixed 15-second testing interval, they perform rapid, successive, controlled hand transfers to touch the alternating hand. The final score is recorded as the mean number of successful touches completed across three separate testing sets.	Postoperative Week 12 and Postoperative Week 24
Dynamic Stability	Assesses quantitative multi-directional dynamic stability using a standardized Y-Balance test apparatus. While maintaining unilateral weight-bearing on one upper limb, the participant uses the free hand to push a target indicator to its maximal distance in three distinct directions: medial, inferolateral, and superolateral. Maximum reach lengths are recorded and normalized to the participant's total upper extremity limb length to express performance as a percentage score.	Postoperative Week 12 and Postoperative Week 24
Psychological Outcome	A self-reported 17-item Tampa Scale for Kinesiophobia questionnaire engineered to evaluate fear of movement, physical activity avoidance, and vulnerability to re-injury related to post-surgical shoulder pain. Individual items are scored via a 4-point Likert ranking matrix. The cumulative rating scales range from a minimum score of 17 to a maximum score of 68, where higher collective margins indicate severe kinesiophobia.	Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
Pain Intensity	Subjective monitoring of regional pain tracking (Visual Analog Scale) using a standard 10-centimeter continuous horizontal vector. The bounds are anchored by the values 0 ("No Pain") and 10 ("Unbearable Pain"). Participants mark independent scores corresponding to three distinct daily conditions: resting pain, functional movement-induced pain, and nocturnal pain disruptions.	Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
Shoulder Joint Range of Motion	Quantitative assessment of active and passive anatomical mobility for shoulder flexion, abduction, internal rotation, and external rotation. All spatial pathways are measured in degrees using a digital goniometer alignment protocol with the patient positioned supine. Active pathways are cataloged as both maximum pain-free active movement arcs and maximum painful threshold boundaries.	Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
Global Rating of Change (GROC) Scale	A single-question self-report tool evaluating perceived recovery over time. Patients answer the question: "When you consider your condition before rehabilitation started, how would you rate your shoulder state currently?". Responses are graded along an 11-point bipolar numerical spectrum ranging from -5 ("Much Worse") through 0 ("No Change") to +5 ("Completely Recovered").	Postoperative Week 6, Week 12, and Week 24
Single Assessment Numeric Evaluation (SANE) Score	A single-sentence patient-reported metric assessing overall shoulder status. Patients answer the question: "How would you rate your shoulder's current functional capacity on a scale from 0 to 100, assuming a completely normal shoulder represents 100%?". The value is recorded as a single integer from 0 ("No Function") to 100 ("Normal/Full Function").	Postoperative Week 6, Week 12, and Week 24
Western Ontario Shoulder Instability Index (WOSI) Score	A highly reliable disease-specific quality of life questionnaire consisting of 21 patient-reported items divided into four domains: physical symptoms, sports/recreation/work, lifestyle, and emotions. Each item is marked on a 100 mm visual analog line, where endpoints track from "No Problem" to "Worst Possible Problem". Higher combined point tallies denote increased disability and functional limitations resulting from shoulder instability.	Postoperative Week 6, Week 12, and Week 24
Shoulder Instability-Return to Sport after Injury (SI-RSI) Scale Total Score	A disease-specific self-report tool evaluating psychological readiness, confidence, and anxiety regarding returning to athletic sports after shoulder instability surgery. The 12-item questionnaire scores responses using a numerical rating format. Higher cumulative totals reflect enhanced psychological readiness and minimal sports-associated anxiety.	Postoperative Week 24

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Elif Turgut, PhD, Professor, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: proprioception; dual task training; neurocognitive training
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Joint Instability
• Other Study ID Numbers: FTREK26/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly to maintain strict participant confidentiality in accordance with the informed consent agreement and institutional review board requirements. Raw datasets contain detailed clinical, surgical, and neurocognitive performance profiles that pose a risk of patient re-identification.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No