Validity and Reliability of Lower Extremity Position Test in Patients with Multiple Sclerosis

Sensory disorders are one of the most important problems in individuals with MS, and these disorders are among the first symptoms of MS. Loss of sense of proprioception is particularly common in patients with MS. Studies show that assessment methods for the quantitative measurement of sensory disorders are lacking. Especially in the clinic, there is no evaluation method that evaluates the sense of proprioception. Therefore, the aim of this study perform the validity and reliability study of the lower extremity position test to evaluate proprioception sense in individuals with MS.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Proprioceptive Disorders; Reliability; Validity; Sensory Impairments
• Intervention / Treatment: Diagnostic test: Lower extremity position test

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey
    • Romatem Bursa Fizik Tedavi ve Rehabilitasyon Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Multiple sclerosis indivuduals

Description

Inclusion Criteria:

• 20-65 years old
• EDSS score between 0-5
• Person who has not had an attack in the last 1 month or who is not in the attack period
• Person without systemic disease such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
• Person who has not undergone surgery that restricts balance function in the lower extremity.
• Person without hip, knee and ankle contracture
• Person who does not have additional neurological disease
• Person who does not use vestibulosupressants or drugs that may cause neuropathy and does not have a history of alcohol use
• To have full cooperation and adaptation to the work
• Individuals who agree to receive treatment will be included in the study.

Exclusion Criteria:

• Being younger than 20 years old and over 65 years old
• Being in the attack period
• Hip, knee or ankle contracture
• Being greater than EDSS 5
• Having systemic diseases such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
• Having an additional neurological disease
• Having a vestibulospressant or drug or alcohol use habit that causes neuropathy
• Not cooperating and adapting to the work

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with multiple sclerosis	Diagnostic test: Lower extremity position test; Assessing proprioception of the lower extremity of individuals multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensorial Assessment-1	Lower Extremity Position test	through study completion, an average of 1 year
Sensorial Assessment-2	Kinesthesia (Inclinometer)	through study completion, an average of 1 year
Balance Assessment-1	Static Balance via single leg stance	through study completion, an average of 1 year
Balance Assessment-2	Dynamic Balance via time up and go	through study completion, an average of 1 year
Walking Speed Assessment	The 10 meter walk test	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Assessment	Demographic form	through study completion, an average of 1 year
Expanded Disability Status Scale (EDSS)	Ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Sensation Disorders; Multiple Sclerosis; Sclerosis; Somatosensory Disorders
• Other Study ID Numbers: E-60116787-020-238650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No