Shoulder InstabilityNCT07631819
Neurocognitive Loading Following Anterior Shoulder Stabilization: A Randomized Controlled Trial
A study testing Standard Rehabilitation and Neurocognitive Loading in people with Shoulder Instability and Joint Instability, run by Hacettepe University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Shoulder Instability, Joint Instability, Postoperative Care
- What is being tested?
- Standard Rehabilitation and Neurocognitive Loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2029
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Conditions
- Shoulder Instability, Joint Instability, Postoperative Care
- Being tested
- Standard Rehabilitation, Neurocognitive Loading
- Keywords
- proprioception, dual task training, neurocognitive training
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard RehabilitationProcedure or surgery
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.
Neurocognitive LoadingProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard Rehabilitation Group | Active comparator | 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. Receives: Procedure: Standard Rehabilitation |
| Neurocognitive Loading Group | Experimental | 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). Receives: Procedure: Standard Rehabilitation; Procedure: Neurocognitive Loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Week 12 and Postoperative Week 24.
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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.
Measured: 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.
Measured: Postoperative Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Turgut, Hacettepe University
- Investigators
- Elif Turgut, PhD, Professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631819
- Sponsor's protocol ID
- FTREK26/24
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurocognitive Loading on Neuromuscular Control, Kinesiophobia, and Clinical Outcomes Following Anterior Shoulder Stabilization Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07631819
- Acronym / sponsor ID
- FTREK26/24
- Conditions
- Shoulder Instability, Joint Instability, Postoperative Care
- Keywords
- proprioception, dual task training, neurocognitive training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation Group | Active comparator | Procedure: Standard RehabilitationParticipants 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. |
| Neurocognitive Loading Group | Experimental | Procedure: Standard Rehabilitation, Procedure: Neurocognitive LoadingParticipants 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard RehabilitationA 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 or surgery | Neurocognitive Loading Group, Standard Rehabilitation Group |
| Neurocognitive LoadingA 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). | Procedure or surgery | Neurocognitive Loading Group |
Primary outcome
Shoulder Joint Proprioception
Time frame: 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.
14 secondary outcomes
Shoulder Joint Proprioception - Force Reproduction Sense
Time frame: Postoperative Week 12 and Postoperative Week 24
Neurocognitive Closed Kinetic Chain Upper Extremity Stability Test
Time frame: Postoperative Week 12 and Postoperative Week 24
Neurocognitive Upper Quarter Y-Balance Test
Time frame: Postoperative Week 12 and Postoperative Week 24
Muscle Strength
Time frame: Postoperative Week 12 and Postoperative Week 24
Time to Peak Torque
Time frame: Postoperative Week 12 and Postoperative Week 24
Closed Kinetic Chain Stability
Time frame: Postoperative Week 12 and Postoperative Week 24
Dynamic Stability
Time frame: Postoperative Week 12 and Postoperative Week 24
Psychological Outcome
Time frame: Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
Pain Intensity
Time frame: Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
Shoulder Joint Range of Motion
Time frame: Baseline (Pre-Rehabilitation), Postoperative Week 6, Week 12, and Week 24
Global Rating of Change (GROC) Scale
Time frame: Postoperative Week 6, Week 12, and Week 24
Single Assessment Numeric Evaluation (SANE) Score
Time frame: Postoperative Week 6, Week 12, and Week 24
Western Ontario Shoulder Instability Index (WOSI) Score
Time frame: Postoperative Week 6, Week 12, and Week 24
Shoulder Instability-Return to Sport after Injury (SI-RSI) Scale Total Score
Time frame: Postoperative Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elif Turgut, PhD, Professor principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Standard Rehabilitation and Neurocognitive Loading in people with Shoulder Instability and Joint Instability, run by Hacettepe University.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Elif Turgut, Professor (+905426582390, elif.turgut.pt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Joint Proprioception (time frame: Postoperative Week 12 and Postoperative Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.