- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05244850
The Relationship of Trunk Control With Lower Extremity Sense, Balance and Gait in Stroke
Study Overview
Detailed Description
When the literature is examined, it is stated that the best functional results are revealed by a good postural control. Because the trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. It provides trunk control, static and dynamic posture, upright posture of the body, and selective trunk movements. Studies have emphasized the importance of intensive rehabilitation therapy targeting trunk control after stroke. Several randomized controlled trials have looked at the effects of trunk exercises in people with stroke. Saeys and colleagues have shown that the effects of trunk exercises improve standing balance and mobility as well as trunk performance.
There are only a few clinical assessment tools in the literature to evaluate trunk performance. The Trunk Disorder Scale examines static and dynamic sitting balance and trunk coordination. "Postural Assessment Scale for Stroke Patients" (PASS) was developed to evaluate postural control and balance in detail in stroke patients. This scale helps to evaluate postural control and balance of stroke patients, to predict prognosis, to shape treatment, and to observe time-dependent development.
In the literature, the rate of sensory problems accompanying stroke is given differently. In the study conducted by Kim and Choi-Kwon in 67 individuals with acute stroke, two-point discrimination, localization identification, position sense, and stereognosis senses were evaluated and it was found that these senses were affected in 85% of the individuals. In another study, it was stated that sensory impairment in the lower extremities affected gait speed, gait symmetry, standing and walking balance.
However, the relationship between trunk control and lower extremity sense of stroke individuals has not been examined in the literature. In addition, studies on balance and walking have not been sufficiently observed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kahramanmaraş, Turkey
- Kahramanmaras Sutcu Imam University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Able to walk 10 m without physical assistance,
- Lower extremity functions are in stages 2-6 according to Brunnstrom motor recovery stages,
- At least 3 days and at most 24 months have passed since the stroke,
- Stroke individuals with a score of 7 or higher on the Hodkinson Mental score
Exclusion Criteria:
- Having neurological and orthopedic problems that may affect walking other than stroke,
- Having a history of cardiovascular and rheumatological diseases that prevent daily activities,
- Lesion or fracture in the lower extremity,
- Lower extremity spasticity 4 according to the modified Ashworth Scale,
- Individuals with aphasia and communication disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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One group
Stroke patients
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Measurements
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trunk Impairment Scale
Time Frame: At baseline
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The Trunk Impairment Scale consists of 3 subscales: static sitting balance (3 items), dynamic sitting balance (10 items) and coordination (4 items).
The maximum score of the owner is 7, 10 and 6 points respectively.
The Total Trunk Impairment Scale score ranges from 0 to 23, with higher scores indicating better trunk control.
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At baseline
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Tinetti Balance and Gait Test
Time Frame: At baseline
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It consists of two parts, walking and balance.
Consisting of 16 questions in total, the scale consists of 9 questions in which balance is evaluated first, followed by 7 questions in which gait is evaluated.
The total score obtained by the evaluated participant from the first 9 questions constitutes the balance score, and the total score obtained from the following 7 questions constitutes the walking score. 2 points means that the requested task was done correctly, 1 point means that the task was done with adaptations, and 0 points means that the desired task could not be done.
A total test score of 18 or less indicates a high fall risk, a moderate fall risk of 19-24 points, and a low-level fall risk with a score above 24.
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At baseline
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Ten Meter Walking Test
Time Frame: At baseline
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During the test, the patient walks at a normal walking pace for a distance of 10 meters and the time is recorded.
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At baseline
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Fugl Mayer Assesment of Sensorimotor Function
Time Frame: At baseline
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The sensory subscale of FMA (FMA-S) consists of 12 sub-parameters; 4 items are for light touch and 8 items are for proprioception sense.
Scoring is between 0-24 points.
The light touch sensation is subjectively tested.
Joint position is tested on the thumb, wrist, elbow, and interphalangeal joint of the glenohumeral joint.
Position sense of the lower extremities is tested on the toe, ankle, knee and hip joint.
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At baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Turkish version of Postural Assessment Scale for Stroke Patients (PASS-T)
Time Frame: At baseline
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PASS is a special scale used to measure balance even in stroke patients with very low physical performance.
The PASS includes 12 items that measure a person's balance performance in situations where the degree of difficulty is different, that is, when changing positions while lying, sitting, standing or standing.
The scale is evaluated between 0-36.
Between 0-3, the feasibility of the movement is tested; "0" is the lowest; "3" is the highest value.
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At baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ipekkkkirmaci
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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