Trunk Restraint in Multiple Sclerosis

NCT06982833 | Completed

• 1 other identifier: Trunk Restraint
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

This study examined the effect of trunk restraint on upper extremity functionality in patients with Multiple Sclerosis (MS).The study included 66 MS patients over the age of 18 and 30 healthy individuals. Participants' upper extremity functions were assessed. Their trunks were then restrained and their upper extremity functions were assessed again. The patients' level of disability (EDSS), trunk control (Trunk Impairment Scale - TIS), upper extremity functionality (Nine Hole Peg Test- 9HPT), were evaluated.

Conditions

Multiple Sclerosis; Healthy Control

Outcome Measures

Primary Outcomes (3)

• Expanded Disability Status Scale (EDSS)

  EDSS was used to determine the patients' level of disability. EDSS is most commonly used to assess the level of disability in persons with MS. In this scale pyramidal, cerebral, cerebellar, brainstem, visual and sensory subparameters are evaluated it consists of ordinal rating system ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments interval (when reaching EDSS 1). The lower scale values of the EDSS measureimpairments based on the neurological examination, while the upper range of the scale (\> EDSS 6) measures handicaps of patients with MS. The determination of EDSS 4 - 6 is heavily dependent on aspects of walking ability.

  up to 6 weeks

• Trunk Impairment Scale (TIS)

  This scale used to evaluate the trunk control of the participants, TIS contains static sitting balance, dynamic sitting balance, and coordination. The total score of this scale is from 0 to 23 and a high score indicates better trunk control. The patients were placed in the standard sitting position for the test and the parameters were applied. Standart position is such that the knees are flexed at 90 degrees, without back support, with the hands and forearms on the thighs and the feet in contact with the ground.

  up to 6 weeks

• Nine-Hole Peg Test (9HPT)

  It is a short, standardized, quantitative test used to evaluate upper extremity function. In the test, patients are asked to pick up nine wooden pegs from a platform as quickly as possible and then place them back into the holes.In our study, the test was conducted twice for both the dominant and non-dominant hands, and the average completion time was recorded.

  up to 6 weeks

Study Arms (1)

Multiple Sclerosis

EXPERIMENTAL

Patients and healthy individuals first filled out the demographic and clinical information form. Then, the Trunk Impairment Scale was evaluated. Participants performed 9DPT with their trunks free and again with their trunks restrained.

Other: Trunk restraint

Interventions

Trunk restraint OTHER

Participants were seated in a chair with a standard sitting height of 26 centimeters. After completing the 9-Hole Peg Test with their trunks free on a table of appropriate height so that their trunks would not flexion, they were secured to the chair crosswise in front of their chest with the help of a non-elastic but firm enough belt that would not cause discomfort to the person. Participants completed the 9-DPT with their trunks constrained.

Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old
• Being diagnosed with MS
• Volunteering

You may not qualify if:

• Having any additional disease or disorder of the upper extremity or trunk (such as disc herniation, fracture)
• Having any additional neurological disease

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (2)

Arzucan Toksal

Zonguldak, Turkey (Türkiye)

Location

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Güngör Beyza Özvar Şenöz, PhD

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

• Bilge Piri Çınar, Assoc. Prof.

  Samsun University

  PRINCIPAL INVESTIGATOR

• Mustafa Açıkgöz, Assoc. Prof

  Zonguldak Bulent Ecevit University

  STUDY DIRECTOR

• Nursena Ceylan

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

• Arzucan Toksal Uçar

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: MS patients and their age-matched healthy control group were evaluated.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: March 10, 2025
• Primary Completion: April 10, 2025
• Study Completion: April 15, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

TU (2)