Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis
Primary Purpose
Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Balance
Functional mobility
Core stability
Trunk position sense
Sponsored by

About this trial
This is an interventional screening trial for Physical Therapy focused on measuring Multiple Sclerosis, Balance, Core Stability, Proprioception, Functional Mobility
Eligibility Criteria
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
Sites / Locations
- Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Etlik, Ankara, Turkey, 06010
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Multiple Sclerosis
Healthy individuals
Arm Description
Patients with confirmed diagnosis of clinically definite MS, Expanded Sisability Status Scale range of 0.5-4 who are able to walk independently.
29 healthy volunteers with matching ages and genders
Outcomes
Primary Outcome Measures
Balance
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.
Balance
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.
Balance
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03566251
First Posted
June 11, 2018
Last Updated
July 8, 2021
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT03566251
Brief Title
Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis
Official Title
The Investigation of the Relationship Between Core Stability and Trunk Position Sense With Balance and Functional Mobility in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy
Keywords
Multiple Sclerosis, Balance, Core Stability, Proprioception, Functional Mobility
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple Sclerosis
Arm Type
Experimental
Arm Description
Patients with confirmed diagnosis of clinically definite MS, Expanded Sisability Status Scale range of 0.5-4 who are able to walk independently.
Arm Title
Healthy individuals
Arm Type
No Intervention
Arm Description
29 healthy volunteers with matching ages and genders
Intervention Type
Other
Intervention Name(s)
Balance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional mobility
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Core stability
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Trunk position sense
Intervention Description
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
Primary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
1 month
Title
Balance
Description
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.
Time Frame
1 month
Title
Balance
Description
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
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taskin Ozkan, postgraduate
Organizational Affiliation
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Etlik, Ankara, Turkey, 06010
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Core Stability, Trunk Position Sense, Balance and Functional Mobility in Patients With Multiple Sclerosis
We'll reach out to this number within 24 hrs