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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. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Taiwan
      • Taipei, Taiwan, 100
        • Rekrutierung
        • School and graduate institution of physical therapy
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: multidirectional instability with HSD
Verhalten: 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
Verhalten: 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.
Aktiver Komparator: patients with multidirectional instability
Verhalten: 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
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Western Ontario Shoulder Index (WOSI)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Taiwan University Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. November 2025

Primärer Abschluss (Geschätzt)

15. Juni 2026

Studienabschluss (Geschätzt)

30. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

3. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Mai 2026

Zuerst gepostet (Tatsächlich)

28. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Mai 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 202501014RINA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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