Multiple SclerosisNCT05325359
L Test in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- L test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2022to 9 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Individuals who applied to Fırat University Training and Research Hospital and were diagnosed with Relapsin-Remitting MS by a neurologist will be included in our study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fırat university
Elâzığ, 23100
Furkan Bilek, 05442772249, fzt.furkanbilek@gmail.com
About this study
Official title: Validity and Reliability of L Test in Persons With Multiple Sclerosis
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.
Read the detailed description
General Information about the Research, Rationale and Objectives:
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 [1, 2]. 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 are frequently observed [1].
Abnormalities and losses in balance management are frequently seen in individuals with MS [3-6] . This abnormality, together with other risk factors, increases the risk of falling [7] and causes limitations in patients' activities of daily living. Studies on balance problems in elderly individuals are frequently investigated in the literature. However, the frequency of falls in this population was found to be 1.5 falls per year [8], while another study investigating individuals with MS found an average of 9 falls per year [7]. In order to develop fall prevention or reduction strategies, it is necessary to evaluate different aspects of motor impairment and to accurately identify factors contributing to falls [9-11]. Since falls among MS patients have a multifactorial etiology, multiple evaluations are necessary to explore the balance problem.
Although various scales have been developed to evaluate the functional level of MS patients [12, 13], the use of frequently applied scales in this patient group allows the results to be compared with other studies and other pathologies. In addition, the use of frequently applied scales does not require special training of raters. Previous studies have used the Berg Balance Scale, the Functional Reach Test, the Timed Get Up and Walk test, and general measures of fall risk (eg, questioning the date of fall) [14-16]. These tests primarily assess the ability to walk forward, turn back, and take a step.
The reliability of the TUG in people with MS has ranged from 'good' to 'excellent' [17,18], but the TUG is only an opportunity for unilateral disorders to turn in a preferred direction [19]. Thus, despite good reliability and validity, TUG currently has limitations in MS that can only be overcome by adding complex and potentially excessively expensive instrumentation. The L test is a modification of the TUG that extends the walking distance from 6 to 20 m and also requires participants to make both clockwise and counterclockwise turns. Therefore, it may have limited sensitivity and the potential to overcome ceiling effects. The L test was originally designed for individuals following lower limb amputation and has since been evaluated in stroke and hospitalized elderly subjects [19-21]. In all three studies, the L test showed good reliability and also showed good correlation with the TUG. The aim of this study is to evaluate the L test in terms of test/retest reliability and concurrent validity with TUG in individuals with MS. 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.
- Detailed Material and Methodology of the Research: The methodological model of the study is the validity and reliability study. Our study will include individuals who applied to Fırat University Training and Research Hospital after ethical approval and were diagnosed with Relapsin-Remitting MS by a neurologist. It is planned to collect the Helsinki Declaration on a voluntary basis from individuals whose data meet the inclusion criteria. As demographic characteristics; The age, gender, body weight, height, EDSS score, occupation and education level of the patients, the history of the disease, the number of falls in the last year and the type of MS will be recorded. 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. 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.
Our study will be carried out as a "test-retest" design and the psychometric properties of the L test in MS patients will be examined. 3 m walk back test, Timed Up and Go, 4-Square Step Test test will be applied to the patients. All assessments will be done by the same physiotherapist. The second evaluation will be performed by the same physiotherapist two days after the first evaluation (test) to measure test-retest reliability. Data collection with the same rater will be preferred to avoid inter-rater variability and error rate between evaluations.
According to Lexell and Downham, 30-50 participants should be included in reliability studies [22]. Considering this recommendation, which defines the reliability of the L test, it is planned to include 50 individuals with MS in our study.
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 duration is recorded, beginning with the word "go" and ending with the participant's back touching the back of the chair [23].
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 the average time will be recorded [24].
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 mean value will be recorded [25].
- Conditions
- Multiple Sclerosis
- Being tested
- L test
- Keywords
- Multiple Sclerosis, Balance, L test, Validity, Gait
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | . 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. 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. Receives: Behavioral: L test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
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
Measured: 1 week
Secondary outcomes (2)
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
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start7 Feb 2022
- Primary completion18 Apr 2022 (estimated)
- Study completion9 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan BİLEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325359
- Sponsor's protocol ID
- Fırat Univers
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.
PubMed 16510748Frzovic D, Morris ME, Vowels L. Clinical tests of standing balance: performance of persons with multiple sclerosis. Arch Phys Med Rehabil. 2000 Feb;81(2):215-21. doi: 10.1016/s0003-9993(00)90144-8.
PubMed 10668778Williams NP, Roland PS, Yellin W. Vestibular evaluation in patients with early multiple sclerosis. Am J Otol. 1997 Jan;18(1):93-100.
PubMed 8989958Daley ML, Swank RL. Quantitative posturography: use in multiple sclerosis. IEEE Trans Biomed Eng. 1981 Sep;28(9):668-71. doi: 10.1109/TBME.1981.324761. No abstract available.
PubMed 7319527Lanzetta D, Cattaneo D, Pellegatta D, Cardini R. Trunk control in unstable sitting posture during functional activities in healthy subjects and patients with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):279-83. doi: 10.1016/j.apmr.2003.05.004.
PubMed 14966714Cattaneo D, De Nuzzo C, Fascia T, Macalli M, Pisoni I, Cardini R. Risks of falls in subjects with multiple sclerosis. Arch Phys Med Rehabil. 2002 Jun;83(6):864-7. doi: 10.1053/apmr.2002.32825.
PubMed 12048669Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
PubMed 11380764DeBolt LS, McCubbin JA. The effects of home-based resistance exercise on balance, power, and mobility in adults with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):290-7. doi: 10.1016/j.apmr.2003.06.003.
PubMed 14966716Cattaneo D, Cardini R. Computerized system to improve voluntary control of balance in neurological patients. Cyberpsychol Behav. 2001 Dec;4(6):687-94. doi: 10.1089/109493101753376632.
PubMed 11800176Cattaneo D, Marazzini F, Crippa A, Cardini R. Do static or dynamic AFOs improve balance? Clin Rehabil. 2002 Dec;16(8):894-9. doi: 10.1191/0269215502cr547oa.
PubMed 12501952Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.
PubMed 12525714Tesio L, Perucca L, Franchignoni FP, Battaglia MA. A short measure of balance in multiple sclerosis: validation through Rasch analysis. Funct Neurol. 1997 Sep-Oct;12(5):255-65.
PubMed 9439943Smith PS, Hembree JA, Thompson ME. Berg Balance Scale and Functional Reach: determining the best clinical tool for individuals post acute stroke. Clin Rehabil. 2004 Nov;18(7):811-8. doi: 10.1191/0269215504cr817oa.
PubMed 15573838Tsang CS, Liao LR, Chung RC, Pang MY. Psychometric properties of the Mini-Balance Evaluation Systems Test (Mini-BESTest) in community-dwelling individuals with chronic stroke. Phys Ther. 2013 Aug;93(8):1102-15. doi: 10.2522/ptj.20120454. Epub 2013 Apr 4.
PubMed 23559522Breisinger TP, Skidmore ER, Niyonkuru C, Terhorst L, Campbell GB. The Stroke Assessment of Fall Risk (SAFR): predictive validity in inpatient stroke rehabilitation. Clin Rehabil. 2014 Dec;28(12):1218-24. doi: 10.1177/0269215514534276. Epub 2014 May 21.
PubMed 24849795
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of L Test in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05325359
- Acronym / sponsor ID
- Fırat Univers
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Balance, L test, Validity, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 18 Apr 2022 (estimated)
- Study completion
- 9 May 2022 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General Information about the Research, Rationale and Objectives:
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 [1, 2]. 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 are frequently observed [1].
Abnormalities and losses in balance management are frequently seen in individuals with MS [3-6] . This abnormality, together with other risk factors, increases the risk of falling [7] and causes limitations in patients' activities of daily living. Studies on balance problems in elderly individuals are frequently investigated in the literature. However, the frequency of falls in this population was found to be 1.5 falls per year [8], while another study investigating individuals with MS found an average of 9 falls per year [7]. In order to develop fall prevention or reduction strategies, it is necessary to evaluate different aspects of motor impairment and to accurately identify factors contributing to falls [9-11]. Since falls among MS patients have a multifactorial etiology, multiple evaluations are necessary to explore the balance problem.
Although various scales have been developed to evaluate the functional level of MS patients [12, 13], the use of frequently applied scales in this patient group allows the results to be compared with other studies and other pathologies. In addition, the use of frequently applied scales does not require special training of raters. Previous studies have used the Berg Balance Scale, the Functional Reach Test, the Timed Get Up and Walk test, and general measures of fall risk (eg, questioning the date of fall) [14-16]. These tests primarily assess the ability to walk forward, turn back, and take a step.
The reliability of the TUG in people with MS has ranged from 'good' to 'excellent' [17,18], but the TUG is only an opportunity for unilateral disorders to turn in a preferred direction [19]. Thus, despite good reliability and validity, TUG currently has limitations in MS that can only be overcome by adding complex and potentially excessively expensive instrumentation. The L test is a modification of the TUG that extends the walking distance from 6 to 20 m and also requires participants to make both clockwise and counterclockwise turns. Therefore, it may have limited sensitivity and the potential to overcome ceiling effects. The L test was originally designed for individuals following lower limb amputation and has since been evaluated in stroke and hospitalized elderly subjects [19-21]. In all three studies, the L test showed good reliability and also showed good correlation with the TUG. The aim of this study is to evaluate the L test in terms of test/retest reliability and concurrent validity with TUG in individuals with MS. 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.
- Detailed Material and Methodology of the Research: The methodological model of the study is the validity and reliability study. Our study will include individuals who applied to Fırat University Training and Research Hospital after ethical approval and were diagnosed with Relapsin-Remitting MS by a neurologist. It is planned to collect the Helsinki Declaration on a voluntary basis from individuals whose data meet the inclusion criteria. As demographic characteristics; The age, gender, body weight, height, EDSS score, occupation and education level of the patients, the history of the disease, the number of falls in the last year and the type of MS will be recorded. 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. 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.
Our study will be carried out as a "test-retest" design and the psychometric properties of the L test in MS patients will be examined. 3 m walk back test, Timed Up and Go, 4-Square Step Test test will be applied to the patients. All assessments will be done by the same physiotherapist. The second evaluation will be performed by the same physiotherapist two days after the first evaluation (test) to measure test-retest reliability. Data collection with the same rater will be preferred to avoid inter-rater variability and error rate between evaluations.
According to Lexell and Downham, 30-50 participants should be included in reliability studies [22]. Considering this recommendation, which defines the reliability of the L test, it is planned to include 50 individuals with MS in our study.
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 duration is recorded, beginning with the word "go" and ending with the participant's back touching the back of the chair [23].
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 the average time will be recorded [24].
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 mean value will be recorded [25].
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | – | Behavioral: L test. 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. 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals who applied to Fırat University Training and Research Hospital and were diagnosed with Relapsin-Remitting MS by a neurologist will be included in our study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L testIt 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. | Behavioural | Multiple sclerosis |
Primary outcome
L test
Time frame: 1 week
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.
Timed Get Up and Go Test
Time frame: 1 week
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
2 secondary outcomes
3-meter Walk Back Test
Time frame: 1 week
10-Meter Walk Test (10MeWT)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 16510748Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.
- Background: PubMed 10668778Frzovic D, Morris ME, Vowels L. Clinical tests of standing balance: performance of persons with multiple sclerosis. Arch Phys Med Rehabil. 2000 Feb;81(2):215-21. doi: 10.1016/s0003-9993(00)90144-8.
- Background: PubMed 8989958Williams NP, Roland PS, Yellin W. Vestibular evaluation in patients with early multiple sclerosis. Am J Otol. 1997 Jan;18(1):93-100.
- Background: PubMed 7319527Daley ML, Swank RL. Quantitative posturography: use in multiple sclerosis. IEEE Trans Biomed Eng. 1981 Sep;28(9):668-71. doi: 10.1109/TBME.1981.324761. No abstract available.
- Background: PubMed 14966714Lanzetta D, Cattaneo D, Pellegatta D, Cardini R. Trunk control in unstable sitting posture during functional activities in healthy subjects and patients with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):279-83. doi: 10.1016/j.apmr.2003.05.004.
- Background: PubMed 12048669Cattaneo D, De Nuzzo C, Fascia T, Macalli M, Pisoni I, Cardini R. Risks of falls in subjects with multiple sclerosis. Arch Phys Med Rehabil. 2002 Jun;83(6):864-7. doi: 10.1053/apmr.2002.32825.
- Background: PubMed 11380764Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.
- Background: PubMed 14966716DeBolt LS, McCubbin JA. The effects of home-based resistance exercise on balance, power, and mobility in adults with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):290-7. doi: 10.1016/j.apmr.2003.06.003.
- Background: PubMed 11800176Cattaneo D, Cardini R. Computerized system to improve voluntary control of balance in neurological patients. Cyberpsychol Behav. 2001 Dec;4(6):687-94. doi: 10.1089/109493101753376632.
- Background: PubMed 12501952Cattaneo D, Marazzini F, Crippa A, Cardini R. Do static or dynamic AFOs improve balance? Clin Rehabil. 2002 Dec;16(8):894-9. doi: 10.1191/0269215502cr547oa.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Furkan Bilek, Lecturer (+905442772249, fzt.furkanbilek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L test (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05325359, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.