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NCT Number: NCT07007429

Effects of Occlusal Imbalance and Clenching on Balance in Stroke Patients

The aim of the study is to investigate the effects of stimulated occlusal imbalance and jaw clenching on balance and fall risk in patients with stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14280, Turkey (Türkiye)

About this study

This randomized controlled study will be conducted on a minimum of 42 stroke patients who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to one of three groups: the ipsilateral side stimulated occlusal imbalance group, the contralateral side stimulated occlusal imbalance group, or the bilateral jaw clenching group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having chronic stroke,
  • A Mini-Mental State Examination score of 24 or higher,
  • Being between 18 and 75 years of age,
  • Having a Brunnstrom stage of 4 or above,
  • Ability to stand independently for 20 seconds or more,
  • Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary,
  • Having opposing mandibular and maxillary second premolars or first molars

Exclusion criteria

  • The presence of severe osteoarthritis in the lower extremity,
  • The presence of cancer or diabetic neuropathy,
  • The presence of vestibular disorder,
  • The presence of lower extremity ulceration or amputation,
  • Hemodynamic instability,
  • The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
  • Having experienced an acute lower extremity injury in the last six weeks,
  • History of lower extremity surgery,
  • Alcohol consumption in the last 24 hours
  • Posterior circulation stroke involving the basilar artery or cerebellum

Treatment and study plan

Ipsilesional Side Stimulated Occlusal Imbalance

Other

In this group, a 1 cm thick cotton roll will be placed on the ipsilesional occlusal surfaces of the patients, and they will be instructed to hold it in place without clenching.

Contralesional Side Stimulated Occlusal Imbalance

Other

In this group, a 1 cm thick cotton roll will be placed on the contralesional occlusal surfaces of the patients, and they will be instructed to hold it in place without clenching.

Bilateral Cotton Roll with Jaw Clenching

Other

In this group, a 1 cm thick cotton roll will be placed on both occlusal surfaces, and the patients will then be instructed to clench their teeth.

Primary outcomes

  1. Overall Postural Stability Index Measurement

    Time frame: Change from baseline overall postural stability index immediately after the intervention

    This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions. Lower scores indicate smaller deviations and better postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.

  2. Fall Risk Assessment

    Time frame: Change from baseline fall risk immediately after the intervention

    Fall risk will be assessed by measuring the patient's ability to maintain balance on an unstable platform. Based on their ability to maintain balance, a fall risk score will be generated, with higher scores indicating a greater risk of falling. The test will be performed with two 30-second trials. The average of the two trials will be calculated automatically by the TechnoBody balance system.

Secondary outcomes

  1. Anteroposterior Stability Index Measurement

    Time frame: Change from baseline anteroposterior stability index immediately after the intervention

    The anteroposterior stability index will be assessed by measuring deviations of the center of gravity in the anteroposterior direction. Lower scores indicate smaller deviations and better anteroposterior postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.

  2. Mediolateral Stability Index Measurement

    Time frame: Change from baseline mediolateral stability index immediately after the intervention

    The mediolateral stability index will be assessed by measuring deviations of the center of gravity in the mediolateral direction. Lower scores indicate smaller deviations and better mediolateral postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.

  3. Weight Bearing Distribution Assessment

    Time frame: Change from baseline weight bearing distribution immediately after the intervention

    Weight-bearing distribution will be assessed by measuring the percentage of body weight borne by each limb during quiet standing. Lower asymmetry values indicate more balanced weight distribution and better postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

Effects of Stimulated Occlusal Imbalance and Jaw Clenching on Balance and Fall Risk in Stroke Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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