Multiple SclerosisNCT06790992
Relıabılıty and valıdıty of the supıne-to-stand Test wıth Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Background: Supine-to-Stand Test (SST) requires muscle strength, flexibility, and dynamic balance and can be used as a marker of functional motor competence in patients with Multiple Sclerosis (pwMS). Objectives: To investigate the reliability and validity of SST in pwMS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Nov 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: PATIENTS DIAGNOSED WITH MULTIPLE SCLEROSIS ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITAL
Who may be able to join
- being diagnosed with revised 2017 McDonald criteria,
- aged older than 18 years,
- ability to walk with or without aid,
- no medication changes in the last 2 months,
- volunteering to participate in the research,
- not having any obstacles to verbal and cognitive communication.
Who cannot join
- having orthopedic, psychological, and other neurological disorders, having had -a relapse in the past 3 months
- having pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relıabılıty and valıdıty of the supıne-to-stand Test as a Measure of Functional Motor Competence ın People wıth Multiple Sclerosis
Background: Supine-to-Stand Test (SST) requires muscle strength, flexibility, and dynamic balance and can be used as a marker of functional motor competence in patients with Multiple Sclerosis (pwMS).
Objectives: To investigate the reliability and validity of SST in pwMS. Methods: Muscle strength was measured using digital goniometer for plantar and dorsiflexor in pwMS (n=44). Manual dexterity was assessed through the 9-hole Peg Test (9HPT). Balance was evaluated using with Berg Balance Test (BBT). Walking speed was assessed using Six-minute Walk test (6MWT). Timed up and go test (TUG), Activity-spesific Balance Confidence scale was used for fear of falling. Quality of life was assessed with MSQOL-54.
Read more
Results: The test's intraclass correlation was 0.984 (95% CI 0.801-0.995). Significant moderate correlations were found between SST and BBT (r=-0.547, p=0.001), TUG (r=0.619, p<0.001), and 6MWT (r=-0.642, p<0.001). A moderate correlation was also found between dominant side plantar flexor strength and SST (r=0.349, p=0.043), but not non-dominant side and bilaterally dorsi flexors (p>0.05). Additionally, no significant correlation was found between SST and bilaterally 9HPT, MSQOL-54 (p>0.05).
Conclusion: This study establishes SST as a reliable and valid tool for assessing functional motor competence in pwMS.
Read the detailed description
Multiple Sclerosis (MS) is a demyelinating, inflammatory, neurodegenerative and progressive disease that causes varying degrees of disability in mobility and functional activities and affects social participation . Common symptoms in MS patients are usually; tone changes, loss of strength in the lower extremities, spasticity, balance and coordination problems, problems, falls, and walking problems . It becomes very difficult for patients with MS (pwMS) to transition between movements and positions considering these symptoms .
The ability to stand from a supine position is the basis for people's ability to get out of bed every day. This activity is very important in situations such as being able to stand by controlling movement while standing and getting up after falls . Supine-to-stand ability requires muscle strength, flexibility, and dynamic balance . The movement includes complex sub- sequential patterns such as sit-to-stand. Factors such as duration, quality of the subsections, and sitting balance also affect supine-to-stand ability . Besides, supine-to-stand ability is seen as indicator for establishing and maintaining bipedal independence. It is evaluated in the pediatric group as fundamental movement skills and motor competence in relation to functional capacity . Therefore, it is essential to determine the clinical applicability of the supine-to stand test (SST) for assessing the competence of pwMS to perform the supine-to-stand task.
SST ability was assessed in different neurological diseases. SST duration has been measured in children with developmental disorders between 4-7 years old . It has been used to assess frailty in patients with Parkinson's disease . Its validity and reliability have recently been tested in patients with stroke . Considering the balance, falls and coordination complaints of MS patients, there is a need to measure SST ability and investigate it with other clinical tests. In particular, not being able to stand up after falling problems and staying in a supine position causes loss of motivation and decreases in quality of life for patients. In order to prevent this problem in neurological diseases, it is necessary to evaluate and treat it by working functionally as a result of this evaluation. In MS patients, especially as the EDSS level increases, balance problems and walking problems increase and muscle strength decreases. In these cases, problems of transition between positions and movements come to the fore.
Therefore, SST test can be used as a marker to show functional motor competence of MS patients. SST can be a quick and easy measurement tool to evaluate the effectiveness of rehabilitation. The aim of this study was to investigate the reliability and validity of SST in pwMS.
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Supine-to-stand Test (SST)
The test was used to evaluate supine-to-stand ability. The patients were first laid in a supine position without shoes on a soft mat in a quiet laboratory environment. The patient was asked to stand up with the command "start". The duration time was recorded. The average of the tests repeated twice was recorded
Measured: 1 years
Muscle Strength
Ankle dorsi and plantar flexors strength were evaluated with digital hand dynamometer (Commander Muscle Tester, JTech, Midvale, USA). Ankle muscle strength could predictor for walking capacity in neurological disorders . pwMS performed 3-s maximum isometric voluntary contraction of ankle dorsiflexor and plantar flexors with the dynamometer placed anterior and posterior to the head of metatarsal bones, respectively . Ankle dorsiflexors and plantar flexor strength were tested separately, bilaterally and twice in the supine and prone position, respectively. The average of the values was taken and recorded as Newton.
Measured: 1 years
Nine Hole Test
The 9HPT was used to assess the fine manual dexterity of patients. The patient was instructed to insert pegs into the nine empty pegs on the nine-hole board before removing the pegs while sitting position. The test, which it was designed to be completed as rapidly as possible, was administered bilaterally in two trials for each hand. An average time was reported. The patient's manual dexterity degrades with time. The 9HPT is reliable within and between test sessions, discriminates between healthy participants and pwMS with varying levels of upper limb impairment, and has a good convergent validity with other manual dexterity and more comprehensive upper limb tests
Measured: 1 years
Berg Balance Test
It was functional measure of balance commonly used in pwMS. The scale consists of 14 functional activities frequently used in daily life (standing up from sitting, standing without support, sitting without support, sitting from standing, transferring, standing with eyes closed, standing with legs together, reaching forward while standing, picking up an object from the floor, looking back, turning 360 degrees, standing on the healthy side of a chair, standing with one foot in front, and standing on one leg). Activities are scored between 0 and 4. If the individual cannot perform the activity, 0 points are given, and if the individual performs it independently, 4 points are given. Low scores indicate impaired balance. The highest score is 56, with 0-20 points indicating impaired balance, 21-40 points indicating acceptable balance, and 41-56 points indicating good balance
Measured: 1 years
Timed Up and Go (TUG)
Test was used for a measure of functional mobility in pwMS . The test measures speed during many functions such as standing up, walking, turning and sitting. In the test, the individual was asked to get up from the chair he was sitting in, walk 3 meters at a safe and normal speed, turn, walk back and sit on the chair and the time was recorded in seconds. As the score increases, pwMS' fear of falling increases.
Measured: 1 years
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test was used to assess walking endurance, following the technique reported by Goldman et al . Each participant was asked to walk as securely and quickly as possible for six minutes without running in a 10-meter corridor. The distance they walked for six minutes was recorded. The test was performed twice, and the average was recorded in centimeters. As the score increases, individuals' walking capacity increases.
Measured: 1 years
Activity-specific Balance Confidence Scale (ABC)
ABC scale is used to fear of falling. The ABC scale is a self-reported measure of balance confidence that includes 16 items from daily life (indoors and ourdoors activity). The things were graded from 0 (no confidence) to 100 (full confidence). As the score increases, confidence in the activity increases
Measured: 1 years
Multiple Sclerosis Quality of Life-54
The test was used to assess the quality of life. It consists of 2 main groups, 12 subgroups and 2 independent items, namely composite physical health (BFS) and composite mental health (BMS). A high score obtained from the scale indicates a high level of quality of life
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Aug 2024
- Primary completion1 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
- Investigators
- hakan polat, phd, Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790992
- Sponsor's protocol ID
- SANKO University: 2024/6-01
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be decided when the study is completed
Publications
VanSant AF. Age differences in movement patterns used by children to rise from a supine position to erect stance. Phys Ther. 1988 Sep;68(9):1330-9. doi: 10.1093/ptj/68.9.1330.
PubMed 3420166Ng SSM, Chen P, Chan TCW, Chang CHL, Cheng RHY, Chow KKL, Yeung AFM, Liu TW, Ho LYW, Yeung JWF, Xu RH, Tse MMY. Reliability and validity of the supine-to-stand test in people with stroke. J Rehabil Med. 2023 Sep 18;55:jrm12372. doi: 10.2340/jrm.v55.12372.
PubMed 37721097
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relıabılıty and valıdıty of the supıne-to-stand Test as a Measure of Functional Motor Competence ın People wıth Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06790992
- Acronym / sponsor ID
- SANKO University: 2024/6-01
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 24 Jan 2025 (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.
Background: Supine-to-Stand Test (SST) requires muscle strength, flexibility, and dynamic balance and can be used as a marker of functional motor competence in patients with Multiple Sclerosis (pwMS).
Objectives: To investigate the reliability and validity of SST in pwMS. Methods: Muscle strength was measured using digital goniometer for plantar and dorsiflexor in pwMS (n=44). Manual dexterity was assessed through the 9-hole Peg Test (9HPT). Balance was evaluated using with Berg Balance Test (BBT). Walking speed was assessed using Six-minute Walk test (6MWT). Timed up and go test (TUG), Activity-spesific Balance Confidence scale was used for fear of falling. Quality of life was assessed with MSQOL-54.
Results: The test's intraclass correlation was 0.984 (95% CI 0.801-0.995). Significant moderate correlations were found between SST and BBT (r=-0.547, p=0.001), TUG (r=0.619, p<0.001), and 6MWT (r=-0.642, p<0.001). A moderate correlation was also found between dominant side plantar flexor strength and SST (r=0.349, p=0.043), but not non-dominant side and bilaterally dorsi flexors (p>0.05). Additionally, no significant correlation was found between SST and bilaterally 9HPT, MSQOL-54 (p>0.05).
Conclusion: This study establishes SST as a reliable and valid tool for assessing functional motor competence in pwMS.
Detailed description
Multiple Sclerosis (MS) is a demyelinating, inflammatory, neurodegenerative and progressive disease that causes varying degrees of disability in mobility and functional activities and affects social participation . Common symptoms in MS patients are usually; tone changes, loss of strength in the lower extremities, spasticity, balance and coordination problems, problems, falls, and walking problems . It becomes very difficult for patients with MS (pwMS) to transition between movements and positions considering these symptoms .
The ability to stand from a supine position is the basis for people's ability to get out of bed every day. This activity is very important in situations such as being able to stand by controlling movement while standing and getting up after falls . Supine-to-stand ability requires muscle strength, flexibility, and dynamic balance . The movement includes complex sub- sequential patterns such as sit-to-stand. Factors such as duration, quality of the subsections, and sitting balance also affect supine-to-stand ability . Besides, supine-to-stand ability is seen as indicator for establishing and maintaining bipedal independence. It is evaluated in the pediatric group as fundamental movement skills and motor competence in relation to functional capacity . Therefore, it is essential to determine the clinical applicability of the supine-to stand test (SST) for assessing the competence of pwMS to perform the supine-to-stand task.
SST ability was assessed in different neurological diseases. SST duration has been measured in children with developmental disorders between 4-7 years old . It has been used to assess frailty in patients with Parkinson's disease . Its validity and reliability have recently been tested in patients with stroke . Considering the balance, falls and coordination complaints of MS patients, there is a need to measure SST ability and investigate it with other clinical tests. In particular, not being able to stand up after falling problems and staying in a supine position causes loss of motivation and decreases in quality of life for patients. In order to prevent this problem in neurological diseases, it is necessary to evaluate and treat it by working functionally as a result of this evaluation. In MS patients, especially as the EDSS level increases, balance problems and walking problems increase and muscle strength decreases. In these cases, problems of transition between positions and movements come to the fore.
Therefore, SST test can be used as a marker to show functional motor competence of MS patients. SST can be a quick and easy measurement tool to evaluate the effectiveness of rehabilitation. The aim of this study was to investigate the reliability and validity of SST in pwMS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PATIENTS DIAGNOSED WITH MULTIPLE SCLEROSIS ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITAL
Key inclusion criteria (6 listed)
- being diagnosed with revised 2017 McDonald criteria,
- aged older than 18 years,
- ability to walk with or without aid,
- no medication changes in the last 2 months,
- volunteering to participate in the research,
Key exclusion criteria (2 listed)
- having orthopedic, psychological, and other neurological disorders, having had -a relapse in the past 3 months
- having pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Supine-to-stand Test (SST)
Time frame: 1 years
The test was used to evaluate supine-to-stand ability. The patients were first laid in a supine position without shoes on a soft mat in a quiet laboratory environment. The patient was asked to stand up with the command "start". The duration time was recorded. The average of the tests repeated twice was recorded
Muscle Strength
Time frame: 1 years
Ankle dorsi and plantar flexors strength were evaluated with digital hand dynamometer (Commander Muscle Tester, JTech, Midvale, USA). Ankle muscle strength could predictor for walking capacity in neurological disorders . pwMS performed 3-s maximum isometric voluntary contraction of ankle dorsiflexor and plantar flexors with the dynamometer placed anterior and posterior to the head of metatarsal bones, respectively . Ankle dorsiflexors and plantar flexor strength were tested separately, bilaterally and twice in the supine and prone position, respectively. The average of the values was taken and recorded as Newton.
Nine Hole Test
Time frame: 1 years
The 9HPT was used to assess the fine manual dexterity of patients. The patient was instructed to insert pegs into the nine empty pegs on the nine-hole board before removing the pegs while sitting position. The test, which it was designed to be completed as rapidly as possible, was administered bilaterally in two trials for each hand. An average time was reported. The patient's manual dexterity degrades with time. The 9HPT is reliable within and between test sessions, discriminates between healthy participants and pwMS with varying levels of upper limb impairment, and has a good convergent validity with other manual dexterity and more comprehensive upper limb tests
Berg Balance Test
Time frame: 1 years
It was functional measure of balance commonly used in pwMS. The scale consists of 14 functional activities frequently used in daily life (standing up from sitting, standing without support, sitting without support, sitting from standing, transferring, standing with eyes closed, standing with legs together, reaching forward while standing, picking up an object from the floor, looking back, turning 360 degrees, standing on the healthy side of a chair, standing with one foot in front, and standing on one leg). Activities are scored between 0 and 4. If the individual cannot perform the activity, 0 points are given, and if the individual performs it independently, 4 points are given. Low scores indicate impaired balance. The highest score is 56, with 0-20 points indicating impaired balance, 21-40 points indicating acceptable balance, and 41-56 points indicating good balance
Timed Up and Go (TUG)
Time frame: 1 years
Test was used for a measure of functional mobility in pwMS . The test measures speed during many functions such as standing up, walking, turning and sitting. In the test, the individual was asked to get up from the chair he was sitting in, walk 3 meters at a safe and normal speed, turn, walk back and sit on the chair and the time was recorded in seconds. As the score increases, pwMS' fear of falling increases.
Six-Minute Walk Test (6MWT)
Time frame: 1 years
The Six-Minute Walk Test was used to assess walking endurance, following the technique reported by Goldman et al . Each participant was asked to walk as securely and quickly as possible for six minutes without running in a 10-meter corridor. The distance they walked for six minutes was recorded. The test was performed twice, and the average was recorded in centimeters. As the score increases, individuals' walking capacity increases.
Activity-specific Balance Confidence Scale (ABC)
Time frame: 1 years
ABC scale is used to fear of falling. The ABC scale is a self-reported measure of balance confidence that includes 16 items from daily life (indoors and ourdoors activity). The things were graded from 0 (no confidence) to 100 (full confidence). As the score increases, confidence in the activity increases
Multiple Sclerosis Quality of Life-54
Time frame: 1 years
The test was used to assess the quality of life. It consists of 2 main groups, 12 subgroups and 2 independent items, namely composite physical health (BFS) and composite mental health (BMS). A high score obtained from the scale indicates a high level of quality of life
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 24 Jan 2025.
- Results publication: PubMed 3420166VanSant AF. Age differences in movement patterns used by children to rise from a supine position to erect stance. Phys Ther. 1988 Sep;68(9):1330-9. doi: 10.1093/ptj/68.9.1330.
- Results publication: PubMed 37721097Ng SSM, Chen P, Chan TCW, Chang CHL, Cheng RHY, Chow KKL, Yeung AFM, Liu TW, Ho LYW, Yeung JWF, Xu RH, Tse MMY. Reliability and validity of the supine-to-stand test in people with stroke. J Rehabil Med. 2023 Sep 18;55:jrm12372. doi: 10.2340/jrm.v55.12372.
- Individual participant dataSharing planned: Undecided. will be decided when the study is completed
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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.
hakan polat, phd principal investigator
Sanko 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 Sanko 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 2 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 24 Jan 2025. 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?
Supine-to-stand Test (SST) (time frame: 1 years). The study lists 8 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 NCT06790992, which also lists 2 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 24 Jan 2025.