Multiple Sclerosis Clinical Trial
Official title:
Validity and Reliability of L Test in Persons With Multiple Sclerosis
NCT number | NCT05325359 |
Other study ID # | Firat Univers |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 7, 2022 |
Est. completion date | May 9, 2022 |
Multiple Sclerosis (MS), a chronic inflammatory disease of the central nervous system, is a disease characterized by myelin, oligodendrocyte and axon damage [1]. Research continues on the autoimmune, infectious, environmental, vascular and genetic origins of this disease, which affects approximately 2.5 million people in the world and is seen 2-3 times more in women than in men. Although the signs and symptoms of the disease vary according to the location of the lesion; Loss of balance and strength, spasticity, sensory disturbances, fatigue, ataxia, autonomic dysfunction, and decreased visual acuity is frequently observed. There are no studies in the literature investigating the validity and reliability of this test in individuals with MS. Reliability is population-specific and it is important to investigate the reliability of the L test in MS patients. Therefore, the aim of our study is to reveal the test-retest reliability and validity of the L test.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 9, 2022 |
Est. primary completion date | April 18, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria for volunteers; Individuals with relapsing-remitting type MS, who are between 18-65, EDSS scores between 1 = and = 5.5, individuals who score 24 and above in Mini Mental State Examination and who can walk a minimum of 20 m independently will be included. Exclusion Criteria: - In addition, exclusion criteria for volunteers; Severe spasticity of the lower extremities (Ashworth score 3 or 4), having an acute MS attack or a history of an attack in the last 1 month, having an orthopedic or systemic problem that would prevent participation in the tests, having another neuromuscular disorder other than MS, visual involvement or diplopia, and is that he has a cardio-pulmonary problem that will prevent him from participating in the tests. |
Country | Name | City | State |
---|---|---|---|
Turkey | Firat university | Elazig |
Lead Sponsor | Collaborator |
---|---|
Firat University |
Turkey,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | L test | It is an expanded version of the TUG and is designed to assess advanced functional ambulation with more detail available elsewhere. It is recorded when the participant gets up from the chair, walks 3 m to a cone, turns 90° to the right, continues to walk 7 m to the next cone, turns 180° left around the cone, then returns to the chair the same way. The test time is recorded, starting with the word "go" and ending with the participant's back touching the back of the chair. | 1 week | |
Primary | Timed Get Up and Go Test | It is applied to assess the balance and fall risk of individuals. The patient is first asked to sit leaning on the chair. The patient is then asked to stand up, walk with regular steps for a predetermined distance of 3 meters, return at the end of 3 meters and sit in a chair. During the test, the patient's walking time is recorded in seconds with a stopwatch. The test was repeated three times and the average value will be recorded | 1 week | |
Secondary | 3-meter Walk Back Test | The 3-meter distance is marked with a black tape and participants are asked to align their heels with the black tape. Individuals are asked to walk backwards as soon as possible with the "walk" command and stop when they reach 3 meters. Meanwhile, the elapsed time is recorded in seconds. Evaluation will be done three times and average time will be recorded | 1 week | |
Secondary | 10-Meter Walk Test (10MeWT) | The 10MeWT was measured concurrently in the 2MWT (10MeWT-2M) and 6MWT (10MeWT-6M) to obtain the walking speeds of the participants. One reason for the simultaneous measurements was that the test protocols and the environmental set-up of the 2MWT, 6MWT and 10MeWT were very similar. Combining these tests could reduce the number of repeated walking and the resulting fatigue for the participants, and thus maximized their compliance to the tests. The walking speeds achieved in the 2MWT (10MeWT-2M) and 6MWT (10MeWT-6M) were treated as distinctive outcomes and analyzed separately because we believed that the instructions given to the participants in the 2MWT and 6MWT were different, possibly resulting in differences in the timed walk tests. | 1 week |
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