Effects of Occlusal Imbalance and Clenching on Balance in Stroke Patients

NCT07007429 | Completed

• 1 other identifier: BEUFTR-9
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Balance

Outcome Measures

Primary Outcomes (2)

• Overall Postural Stability Index Measurement

  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.

  Change from baseline overall postural stability index immediately after the intervention

• Fall Risk Assessment

  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.

  Change from baseline fall risk immediately after the intervention

Secondary Outcomes (3)

• Anteroposterior Stability Index Measurement

  Change from baseline anteroposterior stability index immediately after the intervention

• Mediolateral Stability Index Measurement

  Change from baseline mediolateral stability index immediately after the intervention

• Weight Bearing Distribution Assessment

  Change from baseline weight bearing distribution immediately after the intervention

Study Arms (3)

Ipsilesional Side Stimulated Occlusal Imbalance Group

EXPERIMENTAL

In this group, occlusal imbalance will be induced by placing a cotton roll on the ipsilesional occlusal surfaces of the patients.

Other: Ipsilesional Side Stimulated Occlusal Imbalance

Contralesional Side Stimulated Occlusal Imbalance Group

EXPERIMENTAL

In this group, occlusal imbalance will be induced by placing a cotton roll on the contralesional occlusal surfaces of the patients.

Other: Contralesional Side Stimulated Occlusal Imbalance

Bilateral Cotton Roll with Jaw Clenching Group

EXPERIMENTAL

Patients in the bilateral cotton roll with jaw clenching group will clench their teeth while cotton rolls are placed on both sides of the occlusal surfaces.

Other: Bilateral Cotton Roll with Jaw Clenching

Interventions

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.

Ipsilesional Side Stimulated Occlusal Imbalance Group

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.

Contralesional Side Stimulated Occlusal Imbalance Group

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.

Bilateral Cotton Roll with Jaw Clenching Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14280, Turkey (Türkiye)

Location

Related Publications (12)

• Arene N, Hidler J. Understanding motor impairment in the paretic lower limb after a stroke: a review of the literature. Top Stroke Rehabil. 2009 Sep-Oct;16(5):346-56. doi: 10.1310/tsr1605-346.

  PMID: 19903653 BACKGROUND

• Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.

  PMID: 12574566 BACKGROUND

• Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006 Jan;86(1):30-8. doi: 10.1093/ptj/86.1.30.

  PMID: 16386060 BACKGROUND

• Yates JS, Lai SM, Duncan PW, Studenski S. Falls in community-dwelling stroke survivors: an accumulated impairments model. J Rehabil Res Dev. 2002 May-Jun;39(3):385-94.

  PMID: 12173758 BACKGROUND

• Divani AA, Vazquez G, Barrett AM, Asadollahi M, Luft AR. Risk factors associated with injury attributable to falling among elderly population with history of stroke. Stroke. 2009 Oct;40(10):3286-92. doi: 10.1161/STROKEAHA.109.559195. Epub 2009 Jul 23.

  PMID: 19628798 BACKGROUND

• Tecco S, Polimeni A, Saccucci M, Festa F. Postural loads during walking after an imbalance of occlusion created with unilateral cotton rolls. BMC Res Notes. 2010 May 25;3:141. doi: 10.1186/1756-0500-3-141.

  PMID: 20500818 BACKGROUND

• Tecco S, Salini V, Calvisi V, Colucci C, Orso CA, Festa F, D'Attilio M. Effects of anterior cruciate ligament (ACL) injury on postural control and muscle activity of head, neck and trunk muscles. J Oral Rehabil. 2006 Aug;33(8):576-87. doi: 10.1111/j.1365-2842.2005.01592.x.

  PMID: 16856955 BACKGROUND

• Fujimoto M, Hayakawa L, Hirano S, Watanabe I. Changes in gait stability induced by alteration of mandibular position. J Med Dent Sci. 2001 Dec;48(4):131-6.

  PMID: 12160250 BACKGROUND

• Asseman F, Gahery Y. Effect of head position and visual condition on balance control in inverted stance. Neurosci Lett. 2005 Feb 28;375(2):134-7. doi: 10.1016/j.neulet.2004.10.085. Epub 2004 Nov 24.

  PMID: 15670656 BACKGROUND

• Giannakopoulos NN, Schindler HJ, Hellmann D. Co-contraction behaviour of masticatory and neck muscles during tooth grinding. J Oral Rehabil. 2018 Jul;45(7):504-511. doi: 10.1111/joor.12646. Epub 2018 May 30.

  PMID: 29761534 BACKGROUND

• Giannakopoulos NN, Schindler HJ, Rammelsberg P, Eberhard L, Schmitter M, Hellmann D. Co-activation of jaw and neck muscles during submaximum clenching in the supine position. Arch Oral Biol. 2013 Dec;58(12):1751-60. doi: 10.1016/j.archoralbio.2013.09.002. Epub 2013 Sep 20.

  PMID: 24200301 BACKGROUND

• Giannakopoulos NN, Hellmann D, Schmitter M, Kruger B, Hauser T, Schindler HJ. Neuromuscular interaction of jaw and neck muscles during jaw clenching. J Orofac Pain. 2013 Winter;27(1):61-71. doi: 10.11607/jop.915.

  PMID: 23424721 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• ömer dursun, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• burak mavuş, M.Sc.

  Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator and the researcher administering intervention will be different.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: May 15, 2025
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

TU (1)