- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gaz
-
Gaziantep, Gaz, Turkey (Türkiye), 27090
- Sanko Unıversıty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CTAR Group
Participants received Chin Tuck Against Resistance (CTAR) exercises combined with thermal-tactile stimulation, 3 sessions/week for 8 weeks.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in DYMUS (Dysphagia in Multiple Sclerosis Questionnaire) Total Score
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in EAT-10 (Eating Assessment Tool-10) Score
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Esophageal Diseases
- Otorhinolaryngologic Diseases
- Pharyngeal Diseases
- Multiple Sclerosis
- Deglutition Disorders
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Muscle Stretching Exercises
Other Study ID Numbers
- hakanpolat20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.