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Neurocognitive Loading Following Anterior Shoulder Stabilization: A Randomized Controlled Trial

2 giugno 2026 aggiornato da: Elif Turgut, Hacettepe University

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.

Panoramica dello studio

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.

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.

Sperimentale: 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).

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.

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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Shoulder Joint Proprioception
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24.
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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Shoulder Joint Proprioception - Force Reproduction Sense
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24
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
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24
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
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24
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
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24
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
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24
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
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24
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
Lasso di tempo: Postoperative Week 12 and Postoperative Week 24
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
Lasso di tempo: Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
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
Lasso di tempo: Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
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
Lasso di tempo: Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
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
Lasso di tempo: Postoperative Week 6, Week 12, and Week 24
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
Lasso di tempo: Postoperative Week 6, Week 12, and Week 24
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
Lasso di tempo: Postoperative Week 6, Week 12, and Week 24
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
Lasso di tempo: Postoperative Week 24
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Elif Turgut, PhD, Professor, Hacettepe University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 luglio 2028

Completamento dello studio (Stimato)

1 luglio 2029

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • FTREK26/24

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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