Trunk Control and Disability in Persons With Multiple Sclerosis

NCT06327789 | Completed

• 1 other identifier: ZBEU-MS
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (12)

• 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 measure impairments 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 8 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 8 weeks

• Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA)

  This system is a multiaxial device that objectively measures and records a patient's ability to stabilize the involved joint under dynamic stress. The BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and an overall stability index (OSI). These indexes represent fluctuations around a zero point established before testing when the platform is stable. A high score in the all parameters indicates poor balance. The test was performed in 3 repetitions, each lasting 20 seconds, with a 10-second rest period in between, under different conditions, including eyes open-closed, firm-foam surface, and static-dynamic surface. The average of the three repetitions was calculated automatically by the device

  up to 8 weeks

• Step Length (cm)

  The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.

  up to 8 weeks

• Stride Length (cm)

  The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.

  up to 8 weeks

• Step Width (cm)

  The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.

  up to 8 weeks

• Cadence (steps/min)

  The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.

  up to 8 weeks

• Velocity (m/s)

  The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.

  up to 8 weeks

• Step time (s)

  The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.

  up to 8 weeks

• Stride time (s)

  The temporal-spatial characteristics of gait were assessed through the utilization of dynamic pedobarography. Dynamic pedobarographic analysis was performed with the implementation of a pressure platform (Zebris® FDM 2, dimensions 212.2x60.5x2.5 cm, Zebris Medical GmbH, Germany) positioned at the center of an 8-meter walking path. Patients completed the gait cycle three times, once for forward and once for backward gait, while barefoot.

  up to 8 weeks

• Timed 25-Foot Walk Test (T25FW)

  This test is designed for the evaluation of lower extremity functions.Initiated at the participant's first step, the test concludes upon reaching the finish line. The participants are instructed to walk as expeditiously as feasible within a specified time frame without running. The duration taken to traverse the 25-foot distance, both for the outbound and return segments, is documented, and subsequently, the average of these two durations is calculated.

  up to 8 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 8 weeks

Study Arms (1)

Multiple Sclerosis

Patients who were 18-50 years old, diagnosed with RRMS by a experienced neurologist, and with an EDSS score ≤ 3 were included in this study. Patients with orthopedic or sensory additional problems in the lower extremity, who had an interventional procedure in the last six months, and had an attack in the last three months were excluded from the study.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

diagnosed with relapsing-remitting multiple sclerosis by an experienced neurologist

You may qualify if:

• years old,
• diagnosed with RRMS by an experienced neurologist
• EDSS score ≤ 3

You may not qualify if:

• orthopedic or sensory additional problems in the lower extremity
• who had an interventional procedure in the last six months, and had an attack in the last three months

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent 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

• Bilge Piri Çınar

  Samsun University

  PRINCIPAL INVESTIGATOR

• Güngör Beyza Özvar Şenöz

  Yüksek İhtisas University

  PRINCIPAL INVESTIGATOR

• Hasret Uçar

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

• Serkan Özakbaş

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Mustafa Açıkgöz

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

• Nursena Ceylan

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc physiotherapist

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 25, 2024
• Study Start: December 21, 2021
• Primary Completion: December 25, 2021
• Study Completion: February 21, 2022
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

TU (1)