NCT07261462

Brief Summary

Background:This study aimed to investigate the effects of a short-term tongue-jaw-back isometric exercise program on these muscle groups and their interrelationships in the post-stroke period. Methods: Twelve post-stroke patients were included in the study. A 14-day exercise program, consisting of two daily sessions targeting the tongue, jaw, and back muscles, was administered. Anterior and posterior tongue muscles, jaw muscles, and back muscle strength were assessed before and after the exercise program. Tongue pressure was measured using the Iowa Oral Performance Instrument (IOPI), chewing strength with a hand-held dynamometer, and back strength with a stabilizing pressure biofeedback unit. Results: After the 14-day isometric exercise program, anterior tongue strength (p = 0.025), posterior tongue strength (p = 0.021), and back muscle strength (p = 0.005) showed significant increases compared to pre-treatment values. No significant change was observed in jaw strength (p = 0.475). Spearman correlation analysis revealed no significant relationships between tongue muscles and jaw or back muscles before treatment, and simple correlations after treatment also did not reach significance. However, partial correlation analysis showed that the relationship between tongue muscles was significantly influenced by jaw strength (p = 0.040) and back strength (p = 0.038) after the intervention. Conclusions: Short-term isometric exercises targeting tongue, jaw, and back muscles in post-stroke patients effectively increased tongue and back muscle strength and enhanced the synergistic relationship among these muscle groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable stroke

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

February 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

November 21, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Back musclesPost-strokeTongue strengthRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Motor Functional Status

    Brunnstromm stages were used to evaluate motor recovery levels (upper extremity, hand, and lower extremity) of the hemiplegic side

    The following clinical and functional assessments were performed both before and after the 14-day program

Secondary Outcomes (1)

  • Functional Independence Status

    The following clinical and functional assessments were performed both before and after the 14-day program

Other Outcomes (5)

  • Dysphagia Assessment

    The following clinical and functional assessments were performed both before and after the 14-day program

  • Dysphagia Assessment

    The following clinical and functional assessments were performed both before and after the 14-day program:

  • Tongue Pressure Measurement

    The following clinical and functional assessments were performed both before and after the 14-day program

  • +2 more other outcomes

Study Arms (1)

Exercise Program

EXPERIMENTAL

All participants received isometric strengthening exercises twice daily for 14 days, with each session lasting approximately 30-40 minutes. Each exercise was performed for 15 repetitions, with each repetition held for 5 seconds followed by a rest. The exercise program included the following: Isometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function. Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing. Isometric Exercises for Back Muscles: Patients who could not

Other: Exercise

Interventions

Isometric Exercises for Tongue Muscles: Using a tongue depressor, patients were instructed to press their tongue forward, upward, downward, and to the sides against the depressor. These exercises aim to increase the strength of the tongue muscles, which play a critical role in swallowing function . Isometric Exercises for Jaw Muscles: Patients were asked to perform a chin tuck while in a supine position by tucking their chin toward their chest. Additionally, they were asked to place a soft ball under their chin and press against it to create an isometric contraction. These exercises target the muscles that facilitate swallowing. Isometric Exercises for Back Muscles: Patients who could not sit with proper balance performed the exercises in a supine position with a soft ball placed under their back. They were asked to press their back against the ball to perform an isometric contraction. Patients with sufficient sitting balance were instructed to sit upright, pressing their backs

Exercise Program

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being within the first 30 days of stroke onset
  • being between 18 and 80 years of age
  • having experienced their first stroke
  • undergoing inpatient physical therapy and rehabilitation
  • voluntarily consenting to participate

You may not qualify if:

  • cognitive impairment
  • severe aphasia or communication difficulties
  • a history of other neurological diseases
  • a history of surgery in the oral or jaw region
  • refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nezahat Keleşoğlu Faculty of Health Sciences

Meram, Konya, (541) 847-, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The study was conducted with a single group, and all participants received the exercise intervention. Assessments were performed by the researcher, and no blinding was applied.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants included in the study provided informed voluntary consent. The study was conducted in a single-blind manner, with the researcher who performed the patient assessments being different from the specialist who administered the exercise intervention. Inclusion criteria were: being within the first 30 days of stroke onset; being between 18 and 80 years of age; having experienced their first stroke; undergoing inpatient physical therapy and rehabilitation; and voluntarily consenting to participate. Exclusion criteria were: cognitive impairment, severe aphasia or communication difficulties, a history of other neurological diseases, a history of surgery in the oral or jaw region, and refusal to participate.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

February 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 25, 2022

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

ndividual participant data (IPD) will not be shared because of ethical and privacy restrictions.

Locations