Multiple SclerosisNCT04182269
Reliability and Validity of the Glittre Activities of Daily Living Test in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Patients with Multiple Sclerosis (MS) have reduced functional capacity due to clinical symptoms of the disease, resulting in decreased participation in daily living activities and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Measurement of functional exercise capacity
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 4 Aug 2020
- How long will I take part?
- 5 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers of the patients who applied to Hacettepe University Neurology Department, diagnosed with MS by specialist physician and referred to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department for physiotherapy and rehabilitation program were included in the study.
Who may be able to join
- Between 18-65 years
- Relapsing Remitting Multiple Sclerosis (RRMS) type MS disease.
- Extended Disability Status Scale (EDSS) score of maximum 4.5
- No attacks during the last 3 months
- The medication has not been changed in the last 6 months.
- Getting more than 24 points from the Standardized Mini Mental Test.
Who cannot join
- Having had any musculoskeletal surgery.
- Using a walking aid or orthosis.
- Having a neurological disease other than MS.
- Having orthopedic or rheumatological problems that will affect function.
- Having a peripheral vestibular problem.
- Having a cardiovascular and pulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with Multiple Sclerosis (MS) have reduced functional capacity due to clinical symptoms of the disease, resulting in decreased participation in daily living activities and reduced quality of life. Evaluation of functional capacity and activities of daily living is very important in order to determine appropriate rehabilitation programs and increase the participation of patients in daily life activities. However, although there are many scales evaluating functional capacity and activities of daily living in people with disabilities, there is no specific assessment scale specific to MS patients. Therefore, this study was planned to investigate whether the Glittre Daily Living Activities (ADL) Test, which was developed to measure functional capacity in chronic obstructive pulmonary disease, is a valid and reliable measurement tool in MS patients. For this purpose, a total of 51 participants (25 MS patients and 26 healthy participants) evaluated with Glittre ADL Test.
The relationship between Glittre ADL Test and 6-minute walk test, Notthingham Extended Daily Living Activities Index, Multiple Sclerosis Quality of Life Scale, Fatigue Severity Scale, Balance Assessment Systems Test (MiniBEST Test), Extended Disability Status Scale and 5-repetition sit-to-stand test evaluated with Pearson or Spearman correlation coefficient. For the known group validity, the difference between the patient and control groups compared with the test of the difference between the two means. For reliability, test retest performed. Reliability evaluated with the intraclass correlation coefficient.
Read more
Hypothesis 1: Glittre ADL Test results in MS patients and healthy subjects are different.
Hypothesis 2: Glittre ADL Test is reliable in MS patients.
Hypothesis 3: Glittre ADL Test is valid for evaluating functional exercise capacity in MS patients.
Read the detailed description
Multiple Sclerosis (MS) is a chronic, inflammatory disease characterized by demyelination, myelin damage, axonal loss and gliosis in the Central Nervous System (CNS). MS symptoms vary according to the size of the lesion and its location in the CNS. Clinical symptoms are generally: spasticity, fatigue, muscle weakness, tremor, pain, sensory disturbances, bladder bowel problems, cognitive disorders, depression and sleep disorders. With the progression of the disease, the performance in daily living activities gradually decreases, affecting the quality of life negatively. Maintaining aerobic capacity in chronic diseases such as MS is very important for independence in daily living activities. Functional exercise capacity of MS patients decreases with the effect of symptoms and sedentary lifestyle. The decrease in aerobic capacity can manifest itself with a decrease in walking distance or speed, or a limitation in daily living activities. Decline in aerobic capacity is also associated with many factors such as increased risk of cardiovascular disease, decreased cognitive functions and health-related quality of life. Therefore, aerobic capacity measurement is one of the important physiological measurements in terms of evaluating the existing functional status of individuals and preparing rehabilitation programs appropriately for individuals.
Cardiopulmonary exercise tests (CPET) are accepted as the gold standard in the evaluation of aerobic capacity. These measurements have some limitations that limit their use, such as the high cost of equipment and the need for a well trained team. Today, submaximal tests, questionnaires or scales are widely used as an alternative to CPET in evaluating functional exercise capacity. Since most daily life activities are at the submaximal level, submaximal tests can better determine the functional levels of individuals in daily living activities.
In order to evaluate functional capacity in Chronic Obstructive Pulmonary Disease (COPD), activities similar to daily life activities were selected and the Glittre Daily Living Activities (ADL) Test was developed. It has been shown that the Glittre ADL Test is reliable and valid in evaluating functional exercise capacity in COPD, as well as reflecting the performance in daily living activities for this disease group. The activities in the Glittre ADL Test are those that require the use of both the lower and upper extremities. An important advantage of the test is that the test can reflect functional capacity as well as providing information about performance in daily life activities and that the use of all extremities can be observed during the test.
In this study, the reliability and validity of the Glittre ADL Test in MS patients was investigated. For the criterion validity of the Glittre ADL Test, the correlation with the 6-minute walk test (6MWT) was examined. Patient and control groups were compared for known group validity. Test-retest method was used to determine the reliability of Glittre ADL Test. Intra-observer reliability was evaluated by intraclass correlation coefficient (ICC). The relationship between Glittre ADL Test scores and lower extremity muscle strength, limitation of daily living activities, balance, quality of life, fatigue and disease severity was investigated. Correlations between the time to complete the Glittre ADL Test and the 5 Repetition Sit To Stand Test completion time, Nottingham Extended Activities of Daily Living Scale, Mini Balance Evulation Systems Test, Multiple Sclerosis Quality of Life 54 scale, Fatigue Severity Scale and Expanded Disability Status Scale scores were examined.
- Conditions
- Multiple Sclerosis
- Being tested
- Measurement of functional exercise capacity
- Keywords
- Multiple sclerosis, Glittre ADL test, Functional capacity assesment
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of functional exercise capacityOther
The Glittre Activities of Daily Living (ADL) Test was used to evaluate functional exercise capacity.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Multiple Sclerosis Patients Receives: Other: Measurement of functional exercise capacity | |
| Control Group | Healthy Subjects Receives: Other: Measurement of functional exercise capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glittre Activities of Dailiy Living Test
Functional exercise capacity measurement
Measured: 10 minute
Secondary outcomes (7)
6 minute walk test (6MWT)
Functional exercise capacity measurement 6MWT was performed in accordance with American Thoracic Society guidelines. The start and end points of the test were determined. The test was carried out in a 30-meter corridor, avoiding distractions. 6-minute walking distance recorded in meters at the end of the test.
Measured: 10 minute
Nottingham Extended Daily Living Activities Index (NGGYAI)
Nottingham Extended Daily Living Activities Index (NGGYAI) was used to evaluate the daily living activities. In addition to the Turkish validity and reliability of the index, it has been reported that it is reliable and valid in MS patients. The scale consists of 22 questions covering mobility, kitchen, home and entertainment activities. A higher score 0-66 scale indicates a better activities of daily living.
Measured: 10 minute
Extended Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS) is the most commonly used scale to monitor disease stage and assess disability in multiple sclerosis patients.
Eight functional systems (FS) are evaluated with EDSS (Visual functions, brain stem functions, pyramidal functions, cerebellar functions, sensory functions, bladder and bowel functions, cerebral functions and other). In addition, gait is also evaluated and a score between 0 (normal neurological status) and 10 (death due to MS) is determined by considering functional system scores and the level of independence of the patient in ambulation.
Measured: minimum 30 minute
Fatigue Severity Scale
Fatigue severity scale was used to evaluate the severity of fatigue. The scale consists of 9 items.
Patients are asked to choose one of the options from 1 to 7 for each item in the scale.
The Fatigue Severity Scale score is calculated by averaging the scores of the answers given to the nine items. A high score indicates an increase in the severity of fatigue.
Measured: 10 minute
Multiple Sclerosis Quality of Life İnstrument - 54 (MSQOL-54)
Multiple sclerosis quality of life instrument (MSQOL-54), which was developed for MS patients and was validated and reliable in Turkish, was used to evaluate the quality of life of the patients.
The scale consists of 14 subheading and 54 items. Each subheading is evaluated out of 100 points and 100 points represent the best status and 0 points represent the worst.
The scores of the patients according to their answers to each question are calculated under 14 subheading.
Then, with a separate calculation, according to the scores obtained from 14 subheading, 2 separate scores are obtained as physical and mental.
Measured: 15 minute
Mini-BEST Test (Balance Assessment Systems Test)
Mini-BEST Test (Balance Assessment Systems Test) was used to evaluate the balance.
Mini-BESTest is the shortest version of BESTest. Test include 4 subheading named preparatory movement, reactive postural control, sensory orientation and dynamic gait. Each subheading has its own total scoring. The total score of preparatory movement, reactive postural control and sensory orientation was 6, and the total score of the dynamic walking subheading was 10 points. The highest score in the test is 28.
As the score decreases, the physical condition deteriorates. Each case tested has 3 points, 0-1-2, which are defined as severe, moderate and normal, respectively. One of these 3 points is selected based on the patient's performance in the tested condition.
Measured: 15-20 minute
The 5-repetition sit-to-stand test
This test has been shown to provide information about lower extremity muscle strength in MS patients.
The 5-repetition sit-to-stand test is a measure of the time taken to complete five repetitions of the sit-to-stand movement.
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Oct 2018
- Primary completion15 Oct 2019
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde KAYA, Hacettepe University
- Investigators
- Nezire KÖSE, Prof., Principal investigator, Hacettepe UniversityRana KARABUDAK, Prof., Study chair, Hacettepe UniversityMeryem A TUNCER, Prof., Study chair, Haceetepe UniversityKadriye ARMUTLU, Prof., Principal investigator, Hacettepe UniversityYeliz SALCI, Asts. Prof., Principal investigator, Hacettepe UniversityJale KARAKAYA, Assoc. Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182269
- Sponsor's protocol ID
- Hacettepe UN
- Status last verified
- Feb 2021
- First submitted
- 26 Nov 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
PubMed 25739555Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.
PubMed 15941658Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
PubMed 16372431Nicholl CR, Lincoln NB, Playford ED. The reliability and validity of the Nottingham Extended Activities of Daily Living Scale in patients with multiple sclerosis. Mult Scler. 2002 Oct;8(5):372-6. doi: 10.1191/1352458502ms827oa.
PubMed 12356202Sahin F, Yilmaz F, Ozmaden A, Kotevoglu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Nottingham Extended Activities of Daily Living Scale. Aging Clin Exp Res. 2008 Oct;20(5):400-5. doi: 10.1007/BF03325144.
PubMed 19039280Moller AB, Bibby BM, Skjerbaek AG, Jensen E, Sorensen H, Stenager E, Dalgas U. Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis. Disabil Rehabil. 2012;34(26):2251-8. doi: 10.3109/09638288.2012.683479. Epub 2012 May 22.
PubMed 22612360Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
PubMed 17293726Idiman E, Uzunel F, Ozakbas S, Yozbatiran N, Oguz M, Callioglu B, Gokce N, Bahar Z. Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample. J Neurol Sci. 2006 Jan 15;240(1-2):77-80. doi: 10.1016/j.jns.2005.09.009. Epub 2005 Nov 8.
PubMed 16277993Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
PubMed 6685237Cameron M, Mazumder R, Murchison C, King L. Mini Balance Evaluation Systems Test in people with multiple sclerosis: reflects imbalance but may not predict falls. Gait Posture. 2014;39(1):669. doi: 10.1016/j.gaitpost.2013.08.009. Epub 2013 Oct 17. No abstract available.
PubMed 24184138Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
PubMed 18970977Mansson E, Lexell J. Performance of activities of daily living in multiple sclerosis. Disabil Rehabil. 2004 May 20;26(10):576-85. doi: 10.1080/09638280410001684587.
PubMed 15204511Marrie RA, Hanwell H. General health issues in multiple sclerosis: comorbidities, secondary conditions, and health behaviors. Continuum (Minneap Minn). 2013 Aug;19(4 Multiple Sclerosis):1046-57. doi: 10.1212/01.CON.0000433284.07844.6b.
PubMed 23917100Stickland MK, Butcher SJ, Marciniuk DD, Bhutani M. Assessing exercise limitation using cardiopulmonary exercise testing. Pulm Med. 2012;2012:824091. doi: 10.1155/2012/824091. Epub 2012 Nov 19.
PubMed 23213518Karloh M, Araujo CL, Gulart AA, Reis CM, Steidle LJ, Mayer AF. The Glittre-ADL test reflects functional performance measured by physical activities of daily living in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2016 Apr 8;20(3):223-30. doi: 10.1590/bjpt-rbf.2014.0155.
PubMed 27437713
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Glittre Activities of Daily Living Test in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04182269
- Acronym / sponsor ID
- Hacettepe UN
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Glittre ADL test, Functional capacity assesment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 2 Dec 2019 (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.
Patients with Multiple Sclerosis (MS) have reduced functional capacity due to clinical symptoms of the disease, resulting in decreased participation in daily living activities and reduced quality of life. Evaluation of functional capacity and activities of daily living is very important in order to determine appropriate rehabilitation programs and increase the participation of patients in daily life activities. However, although there are many scales evaluating functional capacity and activities of daily living in people with disabilities, there is no specific assessment scale specific to MS patients. Therefore, this study was planned to investigate whether the Glittre Daily Living Activities (ADL) Test, which was developed to measure functional capacity in chronic obstructive pulmonary disease, is a valid and reliable measurement tool in MS patients. For this purpose, a total of 51 participants (25 MS patients and 26 healthy participants) evaluated with Glittre ADL Test.
The relationship between Glittre ADL Test and 6-minute walk test, Notthingham Extended Daily Living Activities Index, Multiple Sclerosis Quality of Life Scale, Fatigue Severity Scale, Balance Assessment Systems Test (MiniBEST Test), Extended Disability Status Scale and 5-repetition sit-to-stand test evaluated with Pearson or Spearman correlation coefficient. For the known group validity, the difference between the patient and control groups compared with the test of the difference between the two means. For reliability, test retest performed. Reliability evaluated with the intraclass correlation coefficient.
Hypothesis 1: Glittre ADL Test results in MS patients and healthy subjects are different.
Hypothesis 2: Glittre ADL Test is reliable in MS patients.
Hypothesis 3: Glittre ADL Test is valid for evaluating functional exercise capacity in MS patients.
Detailed description
Multiple Sclerosis (MS) is a chronic, inflammatory disease characterized by demyelination, myelin damage, axonal loss and gliosis in the Central Nervous System (CNS). MS symptoms vary according to the size of the lesion and its location in the CNS. Clinical symptoms are generally: spasticity, fatigue, muscle weakness, tremor, pain, sensory disturbances, bladder bowel problems, cognitive disorders, depression and sleep disorders. With the progression of the disease, the performance in daily living activities gradually decreases, affecting the quality of life negatively. Maintaining aerobic capacity in chronic diseases such as MS is very important for independence in daily living activities. Functional exercise capacity of MS patients decreases with the effect of symptoms and sedentary lifestyle. The decrease in aerobic capacity can manifest itself with a decrease in walking distance or speed, or a limitation in daily living activities. Decline in aerobic capacity is also associated with many factors such as increased risk of cardiovascular disease, decreased cognitive functions and health-related quality of life. Therefore, aerobic capacity measurement is one of the important physiological measurements in terms of evaluating the existing functional status of individuals and preparing rehabilitation programs appropriately for individuals.
Cardiopulmonary exercise tests (CPET) are accepted as the gold standard in the evaluation of aerobic capacity. These measurements have some limitations that limit their use, such as the high cost of equipment and the need for a well trained team. Today, submaximal tests, questionnaires or scales are widely used as an alternative to CPET in evaluating functional exercise capacity. Since most daily life activities are at the submaximal level, submaximal tests can better determine the functional levels of individuals in daily living activities.
In order to evaluate functional capacity in Chronic Obstructive Pulmonary Disease (COPD), activities similar to daily life activities were selected and the Glittre Daily Living Activities (ADL) Test was developed. It has been shown that the Glittre ADL Test is reliable and valid in evaluating functional exercise capacity in COPD, as well as reflecting the performance in daily living activities for this disease group. The activities in the Glittre ADL Test are those that require the use of both the lower and upper extremities. An important advantage of the test is that the test can reflect functional capacity as well as providing information about performance in daily life activities and that the use of all extremities can be observed during the test.
In this study, the reliability and validity of the Glittre ADL Test in MS patients was investigated. For the criterion validity of the Glittre ADL Test, the correlation with the 6-minute walk test (6MWT) was examined. Patient and control groups were compared for known group validity. Test-retest method was used to determine the reliability of Glittre ADL Test. Intra-observer reliability was evaluated by intraclass correlation coefficient (ICC). The relationship between Glittre ADL Test scores and lower extremity muscle strength, limitation of daily living activities, balance, quality of life, fatigue and disease severity was investigated. Correlations between the time to complete the Glittre ADL Test and the 5 Repetition Sit To Stand Test completion time, Nottingham Extended Activities of Daily Living Scale, Mini Balance Evulation Systems Test, Multiple Sclerosis Quality of Life 54 scale, Fatigue Severity Scale and Expanded Disability Status Scale scores were examined.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Measurement of functional exercise capacityMultiple Sclerosis Patients |
| Control Group | – | Other: Measurement of functional exercise capacityHealthy Subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers of the patients who applied to Hacettepe University Neurology Department, diagnosed with MS by specialist physician and referred to Hacettepe University Faculty of Health Sciences Physiotherapy and Rehabilitation Department for physiotherapy and rehabilitation program were included in the study.
Key inclusion criteria (6 listed)
- Between 18-65 years
- Relapsing Remitting Multiple Sclerosis (RRMS) type MS disease.
- Extended Disability Status Scale (EDSS) score of maximum 4.5
- No attacks during the last 3 months
- The medication has not been changed in the last 6 months.
Key exclusion criteria (6 listed)
- Having had any musculoskeletal surgery.
- Using a walking aid or orthosis.
- Having a neurological disease other than MS.
- Having orthopedic or rheumatological problems that will affect function.
- Having a peripheral vestibular problem.
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 |
|---|---|---|
| Measurement of functional exercise capacityThe Glittre Activities of Daily Living (ADL) Test was used to evaluate functional exercise capacity. | Other | Control Group, Study Group |
Primary outcome
Glittre Activities of Dailiy Living Test
Time frame: 10 minute
Functional exercise capacity measurement
7 secondary outcomes
6 minute walk test (6MWT)
Time frame: 10 minute
Nottingham Extended Daily Living Activities Index (NGGYAI)
Time frame: 10 minute
Extended Disability Status Scale (EDSS)
Time frame: minimum 30 minute
Fatigue Severity Scale
Time frame: 10 minute
Multiple Sclerosis Quality of Life İnstrument - 54 (MSQOL-54)
Time frame: 15 minute
Mini-BEST Test (Balance Assessment Systems Test)
Time frame: 15-20 minute
The 5-repetition sit-to-stand test
Time frame: 10 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 25739555Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
- Background: PubMed 15941658Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.
- Background: PubMed 16372431Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
- Background: PubMed 12356202Nicholl CR, Lincoln NB, Playford ED. The reliability and validity of the Nottingham Extended Activities of Daily Living Scale in patients with multiple sclerosis. Mult Scler. 2002 Oct;8(5):372-6. doi: 10.1191/1352458502ms827oa.
- Background: PubMed 19039280Sahin F, Yilmaz F, Ozmaden A, Kotevoglu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Nottingham Extended Activities of Daily Living Scale. Aging Clin Exp Res. 2008 Oct;20(5):400-5. doi: 10.1007/BF03325144.
- Background: PubMed 22612360Moller AB, Bibby BM, Skjerbaek AG, Jensen E, Sorensen H, Stenager E, Dalgas U. Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis. Disabil Rehabil. 2012;34(26):2251-8. doi: 10.3109/09638288.2012.683479. Epub 2012 May 22.
- Background: PubMed 17293726Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.
- Background: PubMed 16277993Idiman E, Uzunel F, Ozakbas S, Yozbatiran N, Oguz M, Callioglu B, Gokce N, Bahar Z. Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample. J Neurol Sci. 2006 Jan 15;240(1-2):77-80. doi: 10.1016/j.jns.2005.09.009. Epub 2005 Nov 8.
- Background: PubMed 6685237Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
- Background: PubMed 24184138Cameron M, Mazumder R, Murchison C, King L. Mini Balance Evaluation Systems Test in people with multiple sclerosis: reflects imbalance but may not predict falls. Gait Posture. 2014;39(1):669. doi: 10.1016/j.gaitpost.2013.08.009. Epub 2013 Oct 17. No abstract available.
- Background: PubMed 18970977Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
- Background: PubMed 15204511Mansson E, Lexell J. Performance of activities of daily living in multiple sclerosis. Disabil Rehabil. 2004 May 20;26(10):576-85. doi: 10.1080/09638280410001684587.
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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.
Nezire KÖSE, Prof. principal investigator
Hacettepe University
Rana KARABUDAK, Prof. study chair
Hacettepe University
Meryem A TUNCER, Prof. study chair
Haceetepe University
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 Hacettepe 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 12 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glittre Activities of Dailiy Living Test (time frame: 10 minute). 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 NCT04182269, which also lists 16 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 12 Feb 2021.