NCT03566251

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

June 11, 2018

Last Update Submit

July 8, 2021

Conditions

Keywords

Multiple SclerosisBalanceCore StabilityProprioceptionFunctional Mobility

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 month

  • 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.

    1 month

  • 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

    1 month

Study Arms (2)

Multiple Sclerosis

EXPERIMENTAL

Patients with confirmed diagnosis of clinically definite MS, Expanded Sisability Status Scale range of 0.5-4 who are able to walk independently.

Other: BalanceOther: Functional mobilityOther: Core stabilityOther: Trunk position sense

Healthy individuals

NO INTERVENTION

29 healthy volunteers with matching ages and genders

Interventions

BalanceOTHER

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.

Multiple Sclerosis

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.

Multiple Sclerosis

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.

Multiple Sclerosis

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

Multiple Sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Etlik, Ankara, Turkey, 06010

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Core Stability

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Taskin Ozkan, postgraduate

    Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 25, 2018

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

July 14, 2021

Record last verified: 2021-07

Locations