NCT07612397

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

April 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 19, 2026

Last Update Submit

May 23, 2026

Conditions

Stroke

Keywords

Jaw clenchingGait

Outcome Measures

Primary Outcomes (2)

  • Timed Up and Go (TUG) Test

    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)

    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

Study Arms (2)

Voluntary Jaw Clenching

EXPERIMENTAL

Participants will perform maximal voluntary jaw clenching with bilateral dental cotton rolls placed on the occlusal surfaces.

Other: Voluntary Jaw Clenching

Sham Cotton Roll Placement Without Clenching

SHAM COMPARATOR

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

Interventions

Voluntary Jaw ClenchingOTHER

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.

Voluntary Jaw Clenching
Sham Cotton Roll Placement Without ClenchingOTHER

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.

Sham Cotton Roll Placement Without Clenching

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Merve Tunçdemir

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

  • Ömer Dursun

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

  • Ahmet Burak Mavuş, M.Sc.

    Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Tunçdemir, Asst. Prof.

CONTACT

5069452008merve.kd@hotmail.com

Ömer Dursun, Assoc. Prof.

CONTACT

5426088687fztomrdrsn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2026

First Posted

May 28, 2026

Study Start

June 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations

TU(1)