NCT05663541

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

December 15, 2022

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Demographic Assessment

    through study completion, an average of 1 year

  • Expanded Disability Status Scale (EDSS)

    through study completion, an average of 1 year

Study Arms (1)

Patient with multiple sclerosis

Patient with multiple sclerosis

Diagnostic Test: Lower extremity position test

Interventions

Assessing proprioception of the lower extremity of individuals multiple sclerosis

Patient with multiple sclerosis

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Multiple sclerosis indivuduals

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Romatem Bursa Fizik Tedavi ve Rehabilitasyon Hastanesi

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisSomatosensory Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

December 15, 2022

First Posted

December 23, 2022

Study Start

October 24, 2022

Primary Completion

May 6, 2023

Study Completion

July 24, 2023

Last Updated

December 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations