Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Effects of CTAR and PNF Exercises on Swallowing in Multiple Sclerosis (CTAR-PNF-MS)

21 de julio de 2026 actualizado por: Hakan Polat, Sanko University

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

39

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CTAR Group
Participants received Chin Tuck Against Resistance (CTAR) exercises combined with thermal-tactile stimulation, 3 sessions/week for 8 weeks.
Conductual: CTAR exercise
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.
Experimental: PNF Group
Participants received cervical Proprioceptive Neuromuscular Facilitation (PNF) exercises combined with thermal-tactile stimulation, 3 sessions/week for 8 weeks.
Conductual: PNF exercises
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in DYMUS (Dysphagia in Multiple Sclerosis Questionnaire) Total Score
Periodo de tiempo: 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.
Baseline and week 8 (post-treatment)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in EAT-10 (Eating Assessment Tool-10) Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Change in SWAL-QOL (Swallowing Quality of Life) Score
Periodo de tiempo: Baseline and week 8
A patient-reported outcome measure assessing dysphagia-related quality of life across 11 subdomains, scored 0-100
Baseline and week 8
Change in 100 mL Water Swallow Test Parameters (Swallowing Speed, Volume per Swallow, Duration)
Periodo de tiempo: Baseline and week 8
An objective clinical test measuring swallowing speed (mL/sec), volume per swallow (mL), and total swallowing duration (sec) during ingest
Baseline and week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanko University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2025

Finalización primaria (Actual)

1 de abril de 2026

Finalización del estudio (Actual)

1 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

16 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • hakanpolat20

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir