Disability Level and Trunk Control in Individuals With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Relationship Between Disability Level and Trunk Control in Individuals With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634993
• Other study ID #: 2022-42
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2022
• Source: Hacettepe University
• Contact: Melike Sumeyye Ozen
• Phone: +90 266 606 4517
• Email: mcengiz[@]bandirma.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Trunk control disorders are frequently encountered in individuals with MS. Trunk control is very important for safe and quality movement. Impairment of trunk control reduces the level of independence of individuals during activities of daily living. For this reason, it is extremely important to evaluate the trunk in the examination and treatment of individuals. When the literature was examined, it was seen that studies examining trunk control were insufficient. Therefore, our study was planned to investigate the relationship between disability level and trunk control in individuals with MS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-65

• Having a definite diagnosis of MS

• Expanded Disability Status Scale (EDSS) score of 8.5 and below

• Not having an attack in the last 3 months

Exclusion Criteria:

• Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.

• Having severe vision and hearing problems

• The presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Assessment
Assessment of disability level and trunk control

Locations

Country	Name	City	State
Turkey	Melike Sumeyye Ozen	Bandirma	Balikesir

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded Disability Status Scale	It is used for the follow-up of neurological disability and disease stage in MS patients. A score of 0 on the scale indicates normal neurological status, while a score of 10 means death due to MS. The higher the score, the higher the disability level.	baseline
Primary	Trunk Impairment Scale	This scale; It consists of 3 sub-headings: static sitting balance, dynamic sitting balance and coordination. The lowest score that can be obtained from the scale is 0, and the highest score is 23. The higher the score, the higher the trunk control.	baseline
Primary	"Sit-ups" test	This test is used to evaluate the strength of the core stability muscles. Individuals are asked to flex the trunk while the knees are flexed in the supine position. The number of repetitions they can do for 30 seconds is recorded.	baseline
Primary	Modified "Push-ups" test	This test is used to evaluate the strength of the core stability muscles. Individuals are asked to raise their body up by extending their elbows while in the prone position. The number of repetitions they can do for 30 seconds is recorded.	baseline
Primary	Lateral bridge test	This test is used to evaluate the endurance of the core stability muscles. Individuals are asked to lift their bodies on their forearms and toes in the side-lying position and maintain this position. The time held in the position is recorded. The test is done separately for the right and left sides.	baseline
Primary	Modified "Biering-Sorensen" trunk extension test	This test is used to evaluate the endurance of the core stability muscles. In the prone position, individuals are asked to hang their upper body over the edge of the bed and slightly extend them while their ankles are supported. The time held in the position is recorded.	baseline
Primary	Trunk flexion test	This test is used to evaluate the endurance of the core stability muscles. Individuals are asked to stand with their torso at 60º with the floor, and their knees and hips at 90º. The time held in the position is recorded.	baseline
Primary	"Prone Bridge" test	This test is used to evaluate the endurance of the core stability muscles.Individuals are asked to lift their torso up in the prone position while the elbows are flexed, carrying their body weight on their forearms and toes. The time held in the position is recorded.	baseline