Trunk Control and Disability in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Relationship Between Trunk Control and Disability in Persons With Early Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06327789
• Other study ID #: ZBEU-MS
• Status: Completed
• Start date: December 21, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: March 2024
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 21, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18-50 years old,

• diagnosed with RRMS by an experienced neurologist

• EDSS score = 3

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Turkey	Zonguldak Bülent Ecevit University	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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