Effects of Jaw Clenching on Gait and Mobility in Stroke

May 23, 2026 updated by: Merve Tunçdemir, Bitlis Eren University

Immediate Effects of Jaw Clenching on Gait and Functional Mobility in Patients With Chronic Stroke

The aim of this study is to investigate the immediate effects of jaw clenching on gait and functional mobility in patients with chronic stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized sham-controlled crossover study aims to investigate the immediate effects of jaw clenching on gait and functional mobility in patients with chronic stroke. A minimum of 30 eligible patients will be included. Each participant will complete both the intervention and sham conditions in a randomized sequence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Bolu, Merkez, Turkey (Türkiye), 14280
        • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stroke occurred at least 6 months prior to enrollment.
  • No cognitive or communication impairments that would interfere with participation.
  • Ability to stand independently for 20 seconds or more.
  • Ability to walk 10 meters independently, with or without walking aids or orthoses as needed.
  • Age between 18 and 75 years.
  • Lower extremity Brunnstrom stage of 4 or higher.

Exclusion Criteria:

  • Presence of severe osteoarthritis in the lower extremities.
  • Diagnosis of cancer or diabetic neuropathy.
  • Presence of vestibular disorders.
  • Lower extremity ulceration or amputation.
  • History of vertigo.
  • Alcohol consumption within the past 24 hours.
  • Hemodynamic instability.
  • Stroke affecting the basilar artery or cerebellum (posterior circulation stroke).
  • Presence of neurological disorders such as multiple sclerosis or Parkinson's disease.
  • Acute lower extremity injury within the past 6 weeks.
  • History of lower extremity surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Voluntary Jaw Clenching
Participants will perform maximal voluntary jaw clenching with bilateral dental cotton rolls placed on the occlusal surfaces.
Other: Voluntary Jaw Clenching
In this group, 1-cm-thick cotton rolls will be placed bilaterally on the occlusal surfaces, and patients will be instructed to perform maximal voluntary tooth clenching.
Sham Comparator: Sham Cotton Roll Placement Without Clenching
Participants will receive the same bilateral dental cotton roll positioning on the occlusal surfaces without performing jaw clenching.
Other: Sham Cotton Roll Placement Without Clenching
In this group, 1-cm-thick cotton rolls will be placed bilaterally on the occlusal surfaces without any clenching instruction, and participants will be instructed to keep their jaw relaxed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG) Test
Time Frame: Baseline and immediately post-intervention for both experimental and sham conditions
Functional mobility will be assessed using the Timed Up and Go (TUG) Test. Participants will be timed while rising from a chair, walking 3 meters, turning, walking back, and sitting down. Lower scores indicate better functional mobility.
Baseline and immediately post-intervention for both experimental and sham conditions
10-Meter Walk Test (10MWT)
Time Frame: Baseline and immediately post-intervention for both experimental and sham conditions
Gait speed will be assessed using the 10-Meter Walk Test. Participants will be instructed to walk a 10-meter distance at a comfortable walking speed, and time will be recorded to calculate walking velocity.
Baseline and immediately post-intervention for both experimental and sham conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bitlis Eren University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmet Burak MAVUŞ, M.Sc., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
  • Principal Investigator: Merve Tunçdemir, Bitlis Eren University
  • Principal Investigator: Ömer Dursun, Bitlis Eren University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Beuftr_3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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