NCT05433714

Brief Summary

Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life. Beyond walking straight, turning ability is required in many situations in daily life such as walking around a table, avoiding obstacles and navigating the street. The gait characteristics of walking on a straight and curved road are different. During curved walking, the center of mass of the body shifts to the inner leg as the stance time of the inner leg increases, as opposed to walking on a straight track. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

June 21, 2022

Last Update Submit

October 7, 2022

Conditions

Keywords

multiple scleorsisbalanceWalking

Outcome Measures

Primary Outcomes (2)

  • The Figure of Walk Test

    Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded

    First day

  • The Figure of Walk Test

    Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded

    second day

Secondary Outcomes (4)

  • Berg Balance scale

    First day

  • Timed up and go test

    First day

  • Timed 25-Foot Walk test

    First day

  • Four Square Step Test

    First day

Study Arms (1)

Multiple sclerosis patient

First day, first evaluator will perform all tests, and second day, second evaluator will perform the figure of 8 walk test.

Other: Assesment

Interventions

The figure of walk test, Berg Balance scale, Timed 25-Foot Walk, Timed up and go test, Foursquare walk test

Multiple sclerosis patient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multiple Sclerosis Patients

You may qualify if:

  • Having an EDSS score of 4 and below,
  • Being between the ages of 18-65
  • Willingness to participate in the study

You may not qualify if:

  • Being pregnant or within the first 3 months after giving birth,
  • Receiving corticosteroid therapy in the last 1 month,
  • Using drugs that will affect walking in the last 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Zekiye İpek Katırcı Kırmacı

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

August 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 6, 2022

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations