- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07726667
Effects of CTAR and PNF Exercises on Swallowing in Multiple Sclerosis (CTAR-PNF-MS)
Effects of Proprioceptive Neuromuscular Facilitation and Chin Tuck Against Resistance Exercises on Swallowing Function in Patients With Multiple Sclerosis and Dysphagia: A Randomized Controlled Trial
This study compares two exercise programs for people with multiple sclerosis (MS) who have trouble swallowing. One group did chin exercises against resistance (CTAR), and the other group did neck exercises based on a technique called proprioceptive neuromuscular facilitation (PNF). Both groups also received a sensory technique to help trigger swallowing.
The study tested whether these exercises could improve swallowing ability, swallowing speed, and quality of life related to eating and drinking. Participants were randomly assigned to one of the two exercise groups and were treated for 8 weeks, three times per week. Swallowing was assessed before and after treatment using validated questionnaires and a water-swallow test.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system that frequently causes dysphagia (swallowing difficulty), which can lead to aspiration pneumonia and reduced quality of life. Exercise-based interventions targeting the suprahyoid and infrahyoid muscles are commonly used in dysphagia rehabilitation, but comparative evidence between Chin Tuck Against Resistance (CTAR) exercises and cervical Proprioceptive Neuromuscular Facilitation (PNF) exercises in MS patients is lacking.
This randomized, controlled, single-blind (outcome assessor blinded) trial enrolled adults aged 18-65 with a confirmed diagnosis of MS (per 2017 McDonald criteria), a DYMUS score ≥1, and no relapse in the preceding 6 months. Participants were allocated 1:1 to either the CTAR group or the PNF group using a computer-generated randomization sequence (minimization method, balanced for sex and disease course), with allocation concealed via sequentially numbered, sealed, opaque envelopes.
Both groups received Thermal-Tactile Stimulation (TTS) as a shared baseline treatment. The CTAR group performed isometric chin-tuck exercises against a resistance ball (2-3 sets x 8-12 repetitions per session). The PNF group performed cervical combined isotonic contraction techniques using diagonal movement patterns (30 repetitions per session). Both groups trained 3 sessions per week for 8 weeks (24 sessions total), with total session duration equalized between groups (approximately 30 minutes, including rest periods and TTS).
The primary outcome was change in DYMUS total score from baseline to week 8. Secondary outcomes included the Eating Assessment Tool (EAT-10), 100 mL Water Swallow Test parameters (swallowing duration, speed, and volume), the Functional Oral Intake Scale (FOIS), and the Swallowing Quality of Life Questionnaire (SWAL-QOL). Adverse events related to exercise (pain, fatigue, choking sensation) were systematically monitored at each session
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Gaz
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Gaziantep, Gaz, Turquie (Türkiye), 27090
- Sanko Unıversıty
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- - Confirmed diagnosis of multiple sclerosis according to the 2017 McDonald criteria
- DYMUS (Dysphagia in Multiple Sclerosis) questionnaire score ≥1
- Age between 18 and 65 years
- No relapse within the preceding 6 months
Exclusion Criteria:
- - Pregnancy or breastfeeding
- Presence of another neurological disease that could cause dysphagia
- Presence of pneumonia
- History of head-neck surgery or head-neck cancer
- Persistent neck pain and/or radiculopathy
- Inadequate head control
- Inability to understand or follow verbal commands
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CTAR Group
Participants received Chin Tuck Against Resistance (CTAR) exercises combined with thermal-tactile stimulation, 3 sessions/week for 8 weeks.
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Participants performed isometric chin-tuck exercises against resistance using a ball positioned under the chin.
Each session consisted of 2-3 sets of 8-12 repetitions, with each isometric contraction sustained for 5-10 seconds and 30-60 seconds of rest between sets.
Sessions were conducted 3 times per week for 8 weeks (24 sessions total), supervised by a physiotherapist certified in swallowing rehabilitation.
|
|
Expérimental: PNF Group
Participants received cervical Proprioceptive Neuromuscular Facilitation (PNF) exercises combined with thermal-tactile stimulation, 3 sessions/week for 8 weeks.
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Participants received cervical proprioceptive neuromuscular facilitation using a combined isotonic contraction technique with diagonal movement patterns.
Each repetition involved movement from an extension-left rotation position to a flexion-right rotation position against manual resistance, followed by a 6-second isometric hold and controlled eccentric return; the pattern was also performed in reverse diagonal direction.
A total of 30 repetitions were completed per session without rest between repetitions.
Sessions were conducted 3 times per week for 8 weeks (24 sessions total), supervised by a physiotherapist certified in swallowing
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in DYMUS (Dysphagia in Multiple Sclerosis Questionnaire) Total Score
Délai: Baseline and week 8 (post-treatment)
|
The DYMUS is a 10-item self-report questionnaire assessing oropharyngeal dysphagia in multiple sclerosis patients, scored 0 (no) to 1 (yes) per item, yielding a total score range of 0-10.
Higher scores indicate greater dysphagia severity.
A score ≥3 indicates severe swallowing difficulty.
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Baseline and week 8 (post-treatment)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in EAT-10 (Eating Assessment Tool-10) Score
Délai: Baseline and week 8
|
A 10-item self-report questionnaire assessing dysphagia symptom severity, each item scored 0 (no problem) to 4 (severe problem), total score range 0-40.
Higher scores indicate greater
|
Baseline and week 8
|
|
Change in FOIS (Functional Oral Intake Scale) Level
Délai: Baseline and week 8
|
A 7-point ordinal scale classifying functional oral intake ability; levels 1-3 represent tube dependency, levels 4-7 represent oral intake.
Higher levels indicate better oral intake
|
Baseline and week 8
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Change in SWAL-QOL (Swallowing Quality of Life) Score
Délai: Baseline and week 8
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A patient-reported outcome measure assessing dysphagia-related quality of life across 11 subdomains, scored 0-100
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Baseline and week 8
|
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Change in 100 mL Water Swallow Test Parameters (Swallowing Speed, Volume per Swallow, Duration)
Délai: Baseline and week 8
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An objective clinical test measuring swallowing speed (mL/sec), volume per swallow (mL), and total swallowing duration (sec) during ingest
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Baseline and week 8
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies auto-immunes
- Maladies du système immunitaire
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies auto-immunes démyélinisantes, SNC
- Maladies auto-immunes du système nerveux
- Maladies démyélinisantes
- Maladies de l'oesophage
- Maladies oto-rhino-laryngologiques
- Maladies pharyngées
- Sclérose en plaques
- Troubles de la déglutition
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Thérapeutique
- Modalités de physiothérapie
- Soins aux patients
- Thérapie d'exercice
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Exercice
- Exercices d'étirement musculaire
Autres numéros d'identification d'étude
- hakanpolat20
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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