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Impact of Neuromuscular Control With and Without Electrical Stimulation and Long-term Effect of Kinetic Chain Exercises in Multidirectional Shoulder Instability Patients

20 maggio 2026 aggiornato da: National Taiwan University Hospital

Background: Shoulder instability is commonly observed in adolescents and young females, ranging from asymptomatic multidirectional instability (MDI) to symptomatic conditions. Patients with MDI often experience shoulder pain, muscle tension, and episodes of subluxation. This condition is associated with hypermobility spectrum disorder (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS), both characterized by generalized joint laxity and recurrent joint dislocations, significantly affecting daily activities and athletic performance. Current literature lacks clarity on the actual humeral head displacement, shoulder joint kinetics, and muscle activity characteristics during movement in patients with MDI accompanied by HSD or hEDS. Additionally, the effects of electrical stimulation on different shoulder muscles and its impact on humeral head displacement in MDI patients remain to be validated.

Objective: The purposes of this study are to (1) examine whether patients with hEDS/HSD and MDI have increased humeral head translation compared to healthy controls during three isometric contraction ; (2) investigate the relationship between humeral head translation and associated muscle activity during three isometric exercises ; (3) examine the effect of NMES and NMCT to humerus/scapula muscles on humeral head translations in MDI patients with hEDS/HSD Outcome measurements: The primary outcomes include changes in acromiohumeral distance (AHD) or humeroglenoid distance (HGD) under four conditions (no stimulation, NMCT, BLH/Infraspinatus/MD stimulation, and SA stimulation) during three isometric contractions (shoulder flexion, horizontal adduction, and fully extended elbow holding weight).

The secondary outcomes assess muscle activation differences in BLH, infraspinatus, MD, UT, LT, and SA before and after NMCT.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

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

Luoghi di studio

  • Taiwan
      • Taipei, Taiwan, 100
        • Reclutamento
        • School and graduate institution of physical therapy
        • Contatto:

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

Sì

Descrizione

Inclusion Criteria:

  • Age: Between 20 and 50 years old.

Patients with Multidirectional Shoulder Instability Must Meet the Following Conditions:

(A) Generalized Joint Hypermobility: Beighton score ≥ 4/9. (B) Shoulder Laxity Verified in at Least Two Directions During Clinical Examination (must meet A and B, or A and C): Inferior: Presence of a sulcus sign under the acromion or a positive Gagey hyperabduction test.

Anterior: Positive anterior load and shift test or active shoulder external rotation > 85 degrees or passive shoulder external rotation > 90 degrees.

Posterior: Positive posterior load and shift test or positive posterior jerk test.

(C) Shoulder Pain for at Least Three Months Before the Start of the Study. (D) Signs of Shoulder Instability in Daily Life Without a Traumatic Cause. (E) Ability to Raise the Arm Above 120 Degrees Without Experiencing Subluxation or Dislocation of the Shoulder.

Exclusion Criteria:

  • Shoulder pain caused by trauma. History of shoulder fractures or dislocations. Cervical radiculopathy. Degenerative joint disease of the shoulder. Previous shoulder surgery. Frozen shoulder. Pain score greater than 5 during experimental movements. Redness, swelling, or open wounds on the skin within the experimental area. Sensory abnormalities. Cognitive impairment.

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: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: multidirectional instability with HSD
Comportamentale: neuromuscular eletrical stimulation
The GM300TE COMBO NMES (Gemore Technology Co., Ltd., New Taipei City, Taiwan), a portable machine with dual controllable channels and a manual switch, will be applied to the biceps long head, infraspinatus, middle deltoid, LT and SA. Muscle force generation is modulated by stimulated frequency, pulse width, and intensity [Bdaiwi et al., 2015]. It linearly increases with stimulated amplitude and pulse duration. The electronics of the unit creates the electrical impulses with an output frequency of 50 Hz and a pulse width of 300 microseconds. The synchronous (S) mode and asymmetrical rectangular wave-pulse will be used throughout the experiment following protocol from previous research (Bdaiwi, et al., 2015). The amplitude will be settled as muscle motor-level contraction with self-perception of maximal tolerable intensity. The time of tetanic stimulation is 7 seconds with 20-second intervals between stimulations to avoid muscle fatigue. The two circular electrodes are used on each muscl
Comportamentale: neuromuscular control training
To ensure that the humeral head remains centered during the three specific isometric tasks, the examiner positioned the shoulder according to the direction of instability (anterior, inferior, or posterior) by placing the arm in 20° of shoulder flexion, 0° (neutral), or 10° of extension, respectively. In each position, the examiner gently applied a downward force on the upper arm in a horizontal direction, and the participant was instructed to gently resist the force. The goal was to guide the humeral head gradually toward the center of the glenoid, without excessive scapular movement. This training was directly supervised by a physical therapist, who provided verbal and tactile feedback to ensure correct movement execution (Figure 1). The physical therapist was also responsible for conducting the USG assessment. After a 5-minute familiarization session, participants performed the designated instability-specific isometric task for 3 repetitions.
Comparatore attivo: patients with multidirectional instability
Comportamentale: neuromuscular eletrical stimulation
The GM300TE COMBO NMES (Gemore Technology Co., Ltd., New Taipei City, Taiwan), a portable machine with dual controllable channels and a manual switch, will be applied to the biceps long head, infraspinatus, middle deltoid, LT and SA. Muscle force generation is modulated by stimulated frequency, pulse width, and intensity [Bdaiwi et al., 2015]. It linearly increases with stimulated amplitude and pulse duration. The electronics of the unit creates the electrical impulses with an output frequency of 50 Hz and a pulse width of 300 microseconds. The synchronous (S) mode and asymmetrical rectangular wave-pulse will be used throughout the experiment following protocol from previous research (Bdaiwi, et al., 2015). The amplitude will be settled as muscle motor-level contraction with self-perception of maximal tolerable intensity. The time of tetanic stimulation is 7 seconds with 20-second intervals between stimulations to avoid muscle fatigue. The two circular electrodes are used on each muscl
Comportamentale: neuromuscular control training
To ensure that the humeral head remains centered during the three specific isometric tasks, the examiner positioned the shoulder according to the direction of instability (anterior, inferior, or posterior) by placing the arm in 20° of shoulder flexion, 0° (neutral), or 10° of extension, respectively. In each position, the examiner gently applied a downward force on the upper arm in a horizontal direction, and the participant was instructed to gently resist the force. The goal was to guide the humeral head gradually toward the center of the glenoid, without excessive scapular movement. This training was directly supervised by a physical therapist, who provided verbal and tactile feedback to ensure correct movement execution (Figure 1). The physical therapist was also responsible for conducting the USG assessment. After a 5-minute familiarization session, participants performed the designated instability-specific isometric task for 3 repetitions.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Western Ontario Shoulder Index (WOSI)
Lasso di tempo: At baseline, week 4, and week 8 after the intervention
The Western Ontario Shoulder Instability Index (WOSI) is a patient-reported questionnaire used to evaluate shoulder-related quality of life in individuals with shoulder instability. The questionnaire includes items related to physical symptoms, sports and work function, lifestyle, and emotional well-being. Total scores range from 0 to 2100, with higher scores indicating greater impairment and poorer shoulder function.
At baseline, week 4, and week 8 after the intervention

Collaboratori e investigatori

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

Sponsor

National Taiwan University Hospital

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 (Effettivo)

9 novembre 2025

Completamento primario (Stimato)

15 giugno 2026

Completamento dello studio (Stimato)

30 luglio 2026

Date di iscrizione allo studio

Primo inviato

3 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 202501014RINA

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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