NCT07726667

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 16, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Multiple SclerosisDysphagiaDeglutition Disorders

Outcome Measures

Primary Outcomes (1)

  • Change in DYMUS (Dysphagia in Multiple Sclerosis Questionnaire) Total Score

    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)

Secondary Outcomes (4)

  • Change in EAT-10 (Eating Assessment Tool-10) Score

    Baseline and week 8

  • Change in FOIS (Functional Oral Intake Scale) Level

    Baseline and week 8

  • Change in SWAL-QOL (Swallowing Quality of Life) Score

    Baseline and week 8

  • Change in 100 mL Water Swallow Test Parameters (Swallowing Speed, Volume per Swallow, Duration)

    Baseline and week 8

Study Arms (2)

CTAR Group

EXPERIMENTAL

Participants received Chin Tuck Against Resistance (CTAR) exercises combined with thermal-tactile stimulation, 3 sessions/week for 8 weeks.

Behavioral: CTAR exercise

PNF Group

EXPERIMENTAL

Participants received cervical Proprioceptive Neuromuscular Facilitation (PNF) exercises combined with thermal-tactile stimulation, 3 sessions/week for 8 weeks.

Behavioral: PNF exercises

Interventions

CTAR exerciseBEHAVIORAL

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.

CTAR Group
PNF exercisesBEHAVIORAL

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

PNF Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko Unıversıty

Gaziantep, Gaz, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisDeglutition Disorders

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor was a physiotherapist not involved in intervention delivery and unaware of group allocation. Participants were asked not to disclose their group assignment during assessment sessions
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel exercise arms (CTAR or PNF), both receiving a shared baseline sensory intervention (thermal-tactile stimulation).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dırector

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 24, 2026

Study Start

November 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations