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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05663541
• Other study ID #: E-60116787-020-238650
• Status: Active, not recruiting
• Start date: October 24, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Proprioceptive Disorders
• Reliability
• Sclerosis
• Somatosensory Disorders
• Validity

Intervention

Diagnostic Test:
• Lower extremity position test
Assessing proprioception of the lower extremity of individuals multiple sclerosis

Locations

Country	Name	City	State
Turkey	Romatem Bursa Fizik Tedavi ve Rehabilitasyon Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

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