NCT06988215

Brief Summary

This randomized controlled single-blind study aims to investigate the effect of kinesiology taping combined with resistance exercises on suprahyoid muscle thickness and swallowing function in patients with stroke-related dysphagia. A total of 36 participants will be randomly assigned to an intervention group receiving real kinesiology taping and a control group receiving placebo taping, both combined with standardized swallowing exercises for 6 weeks. Outcome measures include ultrasonographic evaluation of oropharyngeal muscles (geniohyoid, mylohyoid, anterior digastric, and tongue muscles), swallowing function assessed by the Volume-Viscosity Swallow Test, EAT-10, T-SWAL-QOL, Dysphagia Handicap Index, FOIS, and Functional Ambulation Level. This study will contribute to determining effective rehabilitation methods for improving safe swallowing in post-stroke patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 4, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 17, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

Kinesiology TapingDysphagia RehabilitationSuprahyoid MusclesUltrasound AssessmentNeurogenic Dysphagia

Outcome Measures

Primary Outcomes (1)

  • Ultrasound Measurement of Oropharyngeal Muscle Thickness Time Frame: Baseline and Week 6 Outcome Description: The thickness of oropharyngeal muscles, including the mylohyoid, geniohyoid, anterior belly of digastric, and tongue muscles, will be measured

    The thickness of oropharyngeal muscles, including the mylohyoid, geniohyoid, anterior belly of digastric, and tongue muscles, will be measured using ultrasonography at baseline and after 6 weeks of intervention.

    Baseline and Week 6

Secondary Outcomes (5)

  • Change in Swallowing Safety Assessed by Volume-Viscosity Swallow Test (VVST)

    Baseline and Week 6

  • 9Change in Dysphagia Severity Assessed by EAT-10(The Eating Assessment Tool

    Baseline and Week 6

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

    Baseline and Week 6

  • Change in Dysphagia Handicap Index (DHI)

    Baseline and Week 6

  • Change in Functional Independence Measure (FIM)

    Baseline and Week 6

Study Arms (2)

Kinesiology Taping Group

EXPERIMENTAL

Participants in this group will receive real kinesiology taping applied to the suprahyoid region along with standardized effortful swallowing and oromotor exercises. The taping will be applied in three directions (hyoid to clavicle, hyoid to sternum, and horizontal to hyoid) and renewed every three days over a 6-week period. Exercises will be performed daily, 5 sets of 10 swallows (50 total repetitions).

Other: Kinesiology Taping with Exercise

Placebo Taping Group

PLACEBO COMPARATOR

Participants in this group will receive placebo kinesiology taping that mimics the appearance of therapeutic taping, without applying actual tension. The same standardized swallowing and oromotor exercises will be provided daily for 6 weeks, identical to the experimental group.

Other: Placebo Taping with Exercise

Interventions

Real kinesiology taping is applied to the suprahyoid region in three directions (from the hyoid bone to the clavicle, to the sternum, and horizontally). Taping is renewed every three days. Participants also perform effortful swallowing and oromotor exercises daily (5 sets of 10 repetitions) for 6 weeks.

Kinesiology Taping Group

Non-therapeutic kinesiology taping with no tension is applied to the suprahyoid region to mimic the appearance of the therapeutic tape. Participants perform the same daily swallowing and oromotor exercises as the intervention group for 6 weeks

Placebo Taping Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 50 and 80 years
  • Diagnosed with stroke
  • Mini-Mental State Examination (MMSE) score greater than 22
  • Voluntary participation with written informed consent

You may not qualify if:

  • Open wounds or unresolved skin problems in the neck area
  • Known allergy to kinesiology tape or its components
  • Medically unstable conditions
  • Primary esophageal disorders (e.g., achalasia, upper esophageal sphincter dysfunction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training Research Hospital

Istanbul, bahçelievler, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

StrokeDeglutition DisordersCerebrovascular Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elif Büşra Demirel, MD

    SBÜ Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Büşra Demirel, medical doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a single-blind study in which only the participants are unaware of their group assignment. Participants in both the intervention and control groups receive kinesiology taping; however, only the intervention group receives therapeutic taping while the control group receives placebo taping that appears identical. Care providers and investigators are not masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive kinesiology taping combined with swallowing exercises, while the control group will receive placebo taping with the same exercises. Both groups will undergo the intervention for 6 weeks.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 23, 2025

Study Start

March 4, 2025

Primary Completion

October 10, 2025

Study Completion

October 10, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations