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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04750733
Other study ID # 59491012-604.01.0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2021
Est. completion date July 5, 2022

Study information

Verified date July 2022
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is often damaged in multiple sclerosis (MS). Researches on postural control in people with MS (PwMS) have revealed that reduced somatosensory conduction may adversely affect some functions. PwMS have increased postural sway in upright posture than healthy people. They move closer and slower when reaching out or taking a step. Trunk controls are weak and postural responses are delayed. The activation of core muscles is very important for an effective trunk control. Because the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. There are a limited number of studies in the literature showing that core stability is reduced in PwMS. Our knowledge about the effects of this reduction on function in PwMS is very limited.


Description:

The aim of this study is to evaluate core strength and endurance and determine its effect on postural control, knee muscle strength, physical capacity and fatigue parameters in individuals with MS. Also relationship between these parameters will investigate.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 5, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Being diagnosed with MS according to McDonald's criteria - Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score - No attacks during the last 3 months - Being an ambulatory - Volunteering to participate in the study Exclusion Criteria: - Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes - Doing regular sports - Being involved in another physiotherapy and rehabilitation program related to MS

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment
Assessment of core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Core strength Core strength will be evaluated within the scope of core assessment. Curl-Up and Modified Push-Up test will be used for the evaluation of core strength. Baseline
Primary Core endurance Core endurance will be evaluated within the scope of core assessment. Trunk flexor, extensor, lateral endurance and plank will be used in the evaluation of core endurance and recorded as seconds. Baseline
Primary Postural sway Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, double stance on firm and foam surface, tandem stance on firm and foam surface. Baseline
Primary Isokinetic strength Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated with Biodex isokinetic dynamometer at angular velocities of 30,60 and 90°/s. Baseline
Secondary Physical capacity Two-minute walk test (2-MWT) will be used to evaluate the mobility of the people with MS. 2-MWT is a measure of self-paced walking ability and functional capacity. Baseline
Secondary Mobility Timed Up and Go (TUG) will be used. TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking. Baseline
Secondary Fatigue Fatigue Severity Scale (FSS) will be used to evaluate fatigue levels. This scale evaluates the severity of fatigue with 9 questions. Each question scores between 1 (I do not agree) and 7 (fully agree). The FSS score is the average value of nine sections. A high score indicates increased fatigue severity. Baseline
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