- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03566251
Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis
The Investigation of the Relationship Between Core Stability and Trunk Position Sense With Balance and Functional Mobility in Patients With Multiple Sclerosis
The aim of this study is to compare balance, functional mobility, core stability and trunk position sense in patients with Multiple Sclerosis (PwMS) and healthy controls and investigate the relationship between core stability and trunk position sense with balance and functional mobility in PwMS.
Balance and mobility disorders are seen in various degrees in patients with Multiple Sclerosis (PwMS). Balance and mobility impairments are observed in the beginning with the early period and are one of the most common causes of disability in PwMS.
Coordination between the peripheral sensory system, the central sensory-motor system and the musculoskeletal system which generates motor responses is required to provide balance. If one or more of these systems do not function properly, this results in deficiency in trunk stability and also causes balance and mobility disorders.
It has been shown that balance and mobility disorders are mostly associated with loss of strength, spasticity, coordination disorders and sensory loss. Especially, it is known that strength of core are related to balance and mobility. Although core muscle strength is a significant element of trunk stability, position sense is also responsible for trunk stability. When literature is examined, there is no study which examines the relationship between balance and mobility with core muscles' strength and trunk position sense in PwMS. For all these reasons, we think that balance and functional mobility may be related to core stability and trunk position sense in PwMS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our study was carried out with the purpose of comparing balance, functional mobility, core stability and trunk position sense in PwMS and healthy controls and investigating the relationship between core stability and trunk position sense with balance and functional mobility in PwMS.
45 PwMS and 29 healthy volunteers with matching ages and genders were included the study. Balance was assessed by Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). Timed Up and Go (TUG) tests were used to evaluate functional mobility. Core endurance and core strength, which are two specific components of core stability, were evaluated separately. Trunk flexor, trunk extensor, right and left side bridge and prone bridge tests were applied to assess the endurance of the core muscles. The power of core muscles was evaluated with sit-ups and modified push-ups tests. Trunk position sense was evaluated by the trunk reposition test with Dualer IQ digital inclinometer (J-TECH medical, Salt Lake City, UK, USA).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Etlik, Ankara, Turkey, 06010
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of Multiple Sclerosis Disease
- Must be able to walk independently
- The level of disability should be between 0.5-4 according to EDSS
Exclusion Criteria:
- Having acute attack (three months prior to the study)
- Having vision and circulatory system problems,
- Orthopedic problems and pain in the spine, hip, knee or ankle
- Mini-Mental State Examination Test score of less than 25 points
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NON_RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Multiple Sclerosis
Patients with confirmed diagnosis of clinically definite MS, Expanded Sisability Status Scale range of 0.5-4 who are able to walk independently.
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Balance was assessed by Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Postural Stability (PS), Limits of Stability (LOS) and Modified Sensory Organization Tests (MSOT) were evaluated with this system.
PS test assesses static balance during standing up by the ability to hold the center of gravity on the support surface.
The test was performed on both feet and on the left and right foot separately.
LOS test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position.
MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position.
It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces.
Timed Up and Go (TUG) tests were used to evaluate functional mobility.
The TUG measures the time it takes a subject to stand up from an armchair, walk a distance of 3 m, turn, walk back to the chair and sit down.
Time was recorded in seconds with a stopwatch.
Core endurance and core strength, which are two specific components of core stability, were evaluated separately.
Trunk flexor, trunk extensor, right and left side bridge and prone bridge tests were applied to assess the endurance of the core muscles.
Tests were terminated when the subjects said they could not continue the test or when the test position was broken.
A stopwatch was used for the measurements and the results were recorded in seconds.
The power of core muscles was evaluated with sit-ups and modified push-ups tests.
It was recorded how many times the subject could do each test for 30 seconds.
The tests were repeated twice and the best measurement score was recorded for use in the statistical analyses.
Trunk position sense was evaluated by the trunk reposition test with Dualer IQ digital inclinometer (J-TECH medical, Salt Lake City, UK, USA).
Measurements were made in two levels: lumbosacral (LS) and thoracosacral (TS) regions.
The testing took place while standing under three visual-surface conditions.
Participants flexed the trunk approximately 30° in the sagittal plane, holding the position for a count of 3 seconds (position 1) and then participants attempted to repeat the previously attained angle.
Participants indicated verbally when they felt they had reached the angle and held their position for a count of 3 seconds (position 2).
The absolute difference in degrees between positions 1 and 2 was defined as the trunk reposition error (TRE) degree.
Participants generated five scores for each visual-surface condition.
For each condition, the highest and lowest scores were discarded and the mean of the remaining three scores represented the TRE score
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NO_INTERVENTION: Healthy individuals
29 healthy volunteers with matching ages and genders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Balance
Time Frame: 1 month
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Balance was assessed by Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Postural Stability was evaluated with this system (Biodex Medical Systems, 2009).
Postural Stability test was performed on both feet and on the left and right foot separately.
Total stability index score was obtained as the test result.
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1 month
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Balance
Time Frame: 1 month
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Balance was assessed by Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Limits of Stability was evaluated with this system (Biodex Medical Systems, 2009).
Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position.
Total direction control score was obtained as the test result.
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1 month
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Balance
Time Frame: 1 month
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Balance was assessed by Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).
Modified Sensory Organization Tests were evaluated with this system (Biodex Medical Systems, 2009).
MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position.
It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface.
Stability index scores were obtained as the test result
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1 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Taskin Ozkan, postgraduate, Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 228
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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