- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Gaz
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Gaziantep, Gaz, Turchia (Türkiye), 27090
- Sanko Unıversıty
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in DYMUS (Dysphagia in Multiple Sclerosis Questionnaire) Total Score
Lasso di tempo: Baseline and week 8 (post-treatment)
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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)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in EAT-10 (Eating Assessment Tool-10) Score
Lasso di tempo: Baseline and week 8
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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
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Baseline and week 8
|
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Change in FOIS (Functional Oral Intake Scale) Level
Lasso di tempo: Baseline and week 8
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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
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Baseline and week 8
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Change in SWAL-QOL (Swallowing Quality of Life) Score
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie autoimmuni demielinizzanti, SNC
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Malattie esofagee
- Malattie otorinolaringoiatriche
- Malattie faringee
- Sclerosi multipla
- Disturbi della deglutizione
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Terapie
- Modalità di terapia fisica
- Cura del paziente
- Terapia di esercizio
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Esercizio
- Esercizi di stretching muscolare
Altri numeri di identificazione dello studio
- hakanpolat20
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