Clinical trial NCT06043128: Proprioceptive Awareness in Stroke Patients With Different Trunk Impact Levels
Official title: The Relatıonshıp Of Proprıoceptıve Awareness Wıth Balance And Spastıcıty In Patıents Wıth Stroke Wıth Dıfferent Trunk Impact Levels
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Stroke
Balance
Proprioception
Spasticity
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 98
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: It will consist of stroke patients who live in Kocaeli province and exhibit a hemiplegic-hemiparetic picture for at least 6 months after the stroke event.

Brief summary: Trunk control is important for maintaining an upright posture, increasing the quality of movement during dynamic activities, and performing transfer activities safely. Individuals with stroke, which is one of the most common neurological diseases in the world, may have various degrees of trunk affect because the contraction strength of the trunk muscles and their ability to work in harmony with each other are reduced. Depending on the increase in the level of trunk involvement, proprioceptive deterioration, increase in balance problems and deterioration in spasticity characteristics can be observed in patients. However, the relationship between these disorders in individuals with stroke, independent of trunk involvement, has not been defined. Therefore, in this study, we aimed to examine the relationship between proprioceptive awareness and balance and spasticity in stroke patients with different trunk involvement levels. 98 chronic stroke patients will be included in the study. Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria. After recording the sociodemographic and clinical characteristics of the participants, the cognitive status of the patients will be evaluated with a mini mental test. Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score obtained from the GBS. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist who performs other tests. All data obtained will be noted on a prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.

Detailed description: According to the inclusion and exclusion criteria, 98 chronic stroke patients will be included in the study. Written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria for the study. After the sociodemographic and clinical characteristics of the participants are recorded, the cognitive status of the patients will be evaluated with a mini mental test. The Trunk Disability Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score they receive from the GBÖ. Scores close to 23 points on the GBS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. The spasticity of the participants will be evaluated with the Modified Tardiue Scale (MTS), the spasticity of the muscles, and the proprioceptive awareness of the cervical region with the cervical joint error test. Lower extremity proprioceptive awareness will be evaluated with proprioception testing on the Technobody Prokin 252 Isokinetic Balance Platform, and balance skills will be evaluated with dynamic and static balance tests on the Tecnobody Prokin 252 Isonkinetic Balance Platform. The patients' quality of life will be evaluated with a stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist performing other tests. All data obtained will be noted on the prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being between the ages of 35-65
* Being diagnosed with stroke
* Having a stroke for the first time
* Mini Mental Test (MMT) Score ≥ 24
* Brunnstorm lower extremity stage ≥ 4
* Being clinically stable

Exclusion Criteria:

* Mini Mental Score \<24 points
* Having cervical pain of 5 or higher on the visual analog scale
* Having serious vestibular, auditory and visual problems that affect balance (vertigo, etc.)
* Having a history of orthopedic surgery for the trunk and lower extremities
* Presence of an additional neurological disease (MS, Parkinson, Alzheimer's)
* Having joint rigidity that will prevent proprioceptive evaluation

Primary outcomes:
measure: Trunk impairment scale
timeFrame: 20 minutes
measure: Modified Tardieu Scale
timeFrame: 25 minutes
measure: Evaluation of Proprioceptive Awareness
timeFrame: 30 minutes
measure: Evaluation of static and dynamic balance
timeFrame: 15 minutes
measure: Stroke-Specific Quality of Life Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Güler Ertuğrul
Study officials:
affiliation: Süleyman Demirel University Faculty of Health Sciences
name: GÜLER ERTUĞRUL
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University Faculty of Health Sciences
name: MEHMET DURAY
role: STUDY_DIRECTOR
References: