Clinical trial NCT07007429: Effects of Occlusal Imbalance and Clenching on Balance in Stroke Patients
Official title: Effects of Stimulated Occlusal Imbalance and Jaw Clenching on Balance and Fall Risk in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Balance
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Two months or longer elapsed since the stroke,
* A Mini-Mental State Examination score of 24 or higher,
* Being between 45 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.

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

Primary outcomes:
measure: Overall Postural Stability Index Measurement
timeFrame: Change from baseline overall postural stability index immediately after the intervention
measure: Fall Risk Assessment
timeFrame: Change from baseline fall risk immediately after the intervention
Secondary outcomes:
measure: Anteroposterior Stability Index Measurement
timeFrame: Change from baseline anteroposterior stability index immediately after the intervention
measure: Mediolateral Stability Index Measurement
timeFrame: Change from baseline mediolateral stability index immediately after the intervention
measure: Weight Bearing Distribution Assessment
timeFrame: Change from baseline weight bearing distribution immediately after the intervention
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
state: Merkez
Study officials:
affiliation: Bitlis Eren University
name: ömer dursun, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
name: burak mavuş, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.