Neurocognitive Loading Following Anterior Shoulder Stabilization: A Randomized Controlled Trial

NCT07631819 | Not Yet Recruiting DMC

• 1 other identifier: FTREK26/24
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Shoulder Instability; Joint Instability; Postoperative Care

Keywords

proprioception; dual task training; neurocognitive training

Outcome Measures

Primary Outcomes (1)

• Shoulder Joint Proprioception

  Evaluated via an active angle reproduction test in the scapular plane (elevations at 40 and 100 degree) and during glenohumeral internal and external rotation (at 90 degree of abduction and 90 degree of flexion). Measurements are captured using a valid smartphone-based digital gonyometer software application (Goniometer Pro) secured to the participant's wrist. Goggles or blindfolds are used to eliminate visual feedback. The score is recorded as the mean absolute error deviation (in degrees) across three trials per target angle, where a lower error score represents superior proprioceptive accuracy.

  Postoperative Week 12 and Postoperative Week 24.

Secondary Outcomes (14)

• Shoulder Joint Proprioception - Force Reproduction Sense

  Postoperative Week 12 and Postoperative Week 24

• Neurocognitive Closed Kinetic Chain Upper Extremity Stability Test

  Postoperative Week 12 and Postoperative Week 24

• Neurocognitive Upper Quarter Y-Balance Test

  Postoperative Week 12 and Postoperative Week 24

• Muscle Strength

  Postoperative Week 12 and Postoperative Week 24

• Time to Peak Torque

  Postoperative Week 12 and Postoperative Week 24

Study Arms (2)

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.

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).

Procedure: Standard Rehabilitation; Procedure: Neurocognitive Loading

Interventions

Standard Rehabilitation PROCEDURE

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 Loading Group; Standard Rehabilitation Group

Neurocognitive Loading PROCEDURE

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).

Neurocognitive Loading Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Elif Turgut, PhD, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Turgut, Professor

CONTACT

+905426582390; elif.turgut.pt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06