- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07612397
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
30
Phase
- 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
- Name: Ömer Dursun, Assoc. Prof.
- Phone Number: +90 5426088687
- Email: fztomrdrsn@gmail.com
Study Contact Backup
- Name: Merve Tunçdemir, Asst. Prof.
- Phone Number: +90 5069452008
- Email: merve.kd@hotmail.com
Study Locations
-
-
Merkez
-
Bolu, Merkez, Turkey (Türkiye), 14280
- Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
-
Contact:
- Ahmet Mavuş, M.Sc.
- Phone Number: +90 5388178351
- Email: a.burakmavus@gmail.com
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Voluntary Jaw Clenching
Participants will perform maximal voluntary jaw clenching with bilateral dental cotton rolls placed on the occlusal surfaces.
|
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.
|
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
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
Investigators
- 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)
June 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
April 19, 2026
First Submitted That Met QC Criteria
May 23, 2026
First Posted (Actual)
May 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 23, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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