Multiple SclerosisNCT07466823
Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Spasticity, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is a chronic neurological disease frequently associated with spasticity, which may lead to functional limitations and reduced quality of life. Although spasticity is common in MS, detailed descriptions of upper and lower extremity spasticity patterns are limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Spasticity, Spasticity With Multiple Sclerosis
- What is being tested?
- Observational Assessment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with multiple sclerosis and clinical spasticity will be recruited consecutively from the Multiple Sclerosis outpatient clinic of Marmara University Pendik Training and Research Hospital and from patients referred to the Physical Medicine and Rehabilitation outpatient clinic. Eligible participants will undergo clinical evaluation during a single study visit.
Who may be able to join
- Diagnosis of multiple sclerosis according to the 2024 McDonald criteria
- Age ≥ 18 years
- Presence of clinical spasticity defined as Modified Ashworth Scale score ≥ 1 in at least one joint
- Ability to understand study procedures and provide informed consent
- Absence of significant cognitive impairment
Who cannot join
- Presence of orthopedic, rheumatologic, or neurological conditions affecting movement other than multiple sclerosis
- Botulinum toxin type A injection within the previous 3 months
- Previous surgical treatment for upper extremity spasticity
- Bone deformities affecting the upper extremity
- Inability or unwillingness to provide informed consent
- Presence of cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Evrim Karadag Saygi contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854
Istanbul
Secretary General Secretary, +90 2166254545, saikakahvecioglu@gmail.com
About this study
Multiple sclerosis (MS) is a chronic neurological disease frequently associated with spasticity, which may lead to functional limitations and reduced quality of life. Although spasticity is common in MS, detailed descriptions of upper and lower extremity spasticity patterns are limited. A better understanding of spasticity patterns may help improve individualized rehabilitation and treatment planning.
The aim of this study is to classify upper and lower extremity spasticity patterns in patients with multiple sclerosis and to investigate their association with quality of life. Adult patients with MS and clinical spasticity will be recruited from a tertiary care outpatient clinic. Spasticity will be evaluated using the Modified Ashworth Scale, and extremity postures will be recorded to define spasticity patterns. Functional performance will be assessed using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM).
This prospective cross-sectional study is designed to provide a systematic description of spasticity patterns in patients with multiple sclerosis and to examine their relationship with functional outcomes and quality of life.
Read the detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system characterized by motor and sensory impairments, fatigue, balance disorders, and spasticity. Spasticity is one of the most common motor symptoms in MS and affects approximately 60% of patients, with higher prevalence in advanced stages of the disease. Spasticity contributes to functional limitations, pain, gait disturbances, and reduced quality of life.
Despite the high prevalence of spasticity in MS, the characterization of spasticity patterns remains limited. Most studies on spasticity patterns have focused on stroke populations, and data specific to multiple sclerosis are scarce. However, clinical observations suggest that spasticity patterns in MS differ from those seen in other upper motor neuron disorders. A systematic description of upper and lower extremity spasticity patterns may improve clinical decision-making and support individualized rehabilitation and botulinum toxin treatment strategies.
The primary objective of this study is to develop a classification of lower extremity spasticity patterns based on limb postures in patients with multiple sclerosis. Secondary objectives include evaluating upper extremity spasticity patterns and investigating the relationship between spasticity patterns and quality of life.
This prospective cross-sectional study will be conducted at Marmara University Pendik Training and Research Hospital. Adult patients diagnosed with multiple sclerosis according to the 2024 McDonald criteria and presenting with clinical spasticity will be recruited consecutively from neurology and physical medicine and rehabilitation outpatient clinics.
Demographic and clinical data including age, sex, disease duration, MS subtype, and previous spasticity treatments will be recorded. Spasticity will be assessed using the Modified Ashworth Scale. Upper extremity spasticity patterns will be evaluated at the shoulder, elbow, forearm, wrist, and hand levels. Lower extremity spasticity patterns will be evaluated at the hip, knee, and ankle levels.
Functional performance will be assessed using the Timed 25-Foot Walk Test for participants with lower extremity spasticity and the 9-Hole Peg Test for participants with upper extremity spasticity. Disability level will be recorded using the Expanded Disability Status Scale. The impact of spasticity on daily life and psychosocial status will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM).
The results of this study are expected to provide a comprehensive description of spasticity patterns in multiple sclerosis and to improve the understanding of their clinical and functional relevance.
- Being tested
- Observational Assessment
- Keywords
- Multiple sclerosis, Spasticity, Spasticity patterns, PRISM, Upper extremity spasticity, Lower extremity spasticity
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational AssessmentOther
This is an observational study without therapeutic intervention. Participants will undergo clinical assessment of spasticity patterns, functional performance tests, and patient-reported outcome measures during a single study visit.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis With Spasticity | Adult patients with multiple sclerosis and clinical spasticity will be evaluated in a single study visit. Spasticity patterns of the upper and lower extremities will be assessed using the Modified Ashworth Scale and limb posture evaluation. Functional performance will be evaluated using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be assessed using the Patient-Reported Impact of Spasticity Measure (PRISM). Receives: Other: Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of Upper and Lower Extremity Spasticity Patterns
Upper and lower extremity spasticity patterns will be classified based on limb postures and spasticity severity assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive muscle stretching and is scored from 0 to 4 (0 = no increase in muscle tone; 1 = slight increase in muscle tone; 1+ = slight increase in tone with minimal resistance through less than half of the range of motion; 2 = more marked increase in tone through most of the range of motion; 3 = considerable increase in muscle tone; 4 = affected part rigid in flexion or extension). Higher scores indicate greater spasticity.
Spasticity will be evaluated at the shoulder, elbow, forearm, wrist, and hand for the upper extremity and at the hip, knee, and ankle for the lower extremity. Based on these assessments, patients will be categorized according to their upper and lower extremity spasticity patterns.
Measured: Baseline (single study visit)
Secondary outcomes (4)
Impact of Spasticity on Quality of Life
The impact of spasticity on quality of life will be assessed using the Patient-Reported Impact of Spasticity Measure (PRISM). The PRISM is a patient-reported outcome measure with a total score ranging from 0 to 164, where higher scores indicate a greater negative impact of spasticity on daily life and psychosocial functioning.
Measured: Baseline (single study visit)
Lower Extremity Functional Performance
Lower extremity function will be assessed using the Timed 25-Foot Walk Test. Participants will walk a distance of 7.62 meters twice, and the average completion time in seconds will be recorded.
Measured: Baseline (single study visit)
Upper Extremity Manual Dexterity
Upper extremity manual dexterity will be assessed using the 9-Hole Peg Test. The test will be performed twice for each hand, and the average completion time in seconds will be recorded.
Measured: Baseline (single study visit)
Spasticity Severity Assessed by the Modified Ashworth Scale
Spasticity severity will be assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive muscle stretching and is scored from 0 to 4 (0 = no increase in muscle tone; 1 = slight increase in muscle tone; 1+ = slight increase in tone with minimal resistance through less than half of the range of motion; 2 = more marked increase in tone through most of the range of motion; 3 = considerable increase in muscle tone; 4 = affected part rigid in flexion or extension). Higher scores indicate greater spasticity severity.
Spasticity will be evaluated in the shoulder, elbow, forearm, wrist, and hand for the upper extremity and in the hip, knee, and ankle for the lower extremity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466823
- Sponsor's protocol ID
- MarmaraU-FTR-SKA-1
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07466823
- Acronym / sponsor ID
- MarmaraU-FTR-SKA-1
- Keywords
- Multiple sclerosis, Spasticity, Spasticity patterns, PRISM, Upper extremity spasticity, Lower extremity spasticity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Mar 2026 (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) is a chronic neurological disease frequently associated with spasticity, which may lead to functional limitations and reduced quality of life. Although spasticity is common in MS, detailed descriptions of upper and lower extremity spasticity patterns are limited. A better understanding of spasticity patterns may help improve individualized rehabilitation and treatment planning.
The aim of this study is to classify upper and lower extremity spasticity patterns in patients with multiple sclerosis and to investigate their association with quality of life. Adult patients with MS and clinical spasticity will be recruited from a tertiary care outpatient clinic. Spasticity will be evaluated using the Modified Ashworth Scale, and extremity postures will be recorded to define spasticity patterns. Functional performance will be assessed using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM).
This prospective cross-sectional study is designed to provide a systematic description of spasticity patterns in patients with multiple sclerosis and to examine their relationship with functional outcomes and quality of life.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system characterized by motor and sensory impairments, fatigue, balance disorders, and spasticity. Spasticity is one of the most common motor symptoms in MS and affects approximately 60% of patients, with higher prevalence in advanced stages of the disease. Spasticity contributes to functional limitations, pain, gait disturbances, and reduced quality of life.
Despite the high prevalence of spasticity in MS, the characterization of spasticity patterns remains limited. Most studies on spasticity patterns have focused on stroke populations, and data specific to multiple sclerosis are scarce. However, clinical observations suggest that spasticity patterns in MS differ from those seen in other upper motor neuron disorders. A systematic description of upper and lower extremity spasticity patterns may improve clinical decision-making and support individualized rehabilitation and botulinum toxin treatment strategies.
The primary objective of this study is to develop a classification of lower extremity spasticity patterns based on limb postures in patients with multiple sclerosis. Secondary objectives include evaluating upper extremity spasticity patterns and investigating the relationship between spasticity patterns and quality of life.
This prospective cross-sectional study will be conducted at Marmara University Pendik Training and Research Hospital. Adult patients diagnosed with multiple sclerosis according to the 2024 McDonald criteria and presenting with clinical spasticity will be recruited consecutively from neurology and physical medicine and rehabilitation outpatient clinics.
Demographic and clinical data including age, sex, disease duration, MS subtype, and previous spasticity treatments will be recorded. Spasticity will be assessed using the Modified Ashworth Scale. Upper extremity spasticity patterns will be evaluated at the shoulder, elbow, forearm, wrist, and hand levels. Lower extremity spasticity patterns will be evaluated at the hip, knee, and ankle levels.
Functional performance will be assessed using the Timed 25-Foot Walk Test for participants with lower extremity spasticity and the 9-Hole Peg Test for participants with upper extremity spasticity. Disability level will be recorded using the Expanded Disability Status Scale. The impact of spasticity on daily life and psychosocial status will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM).
The results of this study are expected to provide a comprehensive description of spasticity patterns in multiple sclerosis and to improve the understanding of their clinical and functional relevance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis With Spasticity | – | Other: Observational AssessmentAdult patients with multiple sclerosis and clinical spasticity will be evaluated in a single study visit. Spasticity patterns of the upper and lower extremities will be assessed using the Modified Ashworth Scale and limb posture evaluation. Functional performance will be evaluated using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be assessed using the Patient-Reported Impact of Spasticity Measure (PRISM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with multiple sclerosis and clinical spasticity will be recruited consecutively from the Multiple Sclerosis outpatient clinic of Marmara University Pendik Training and Research Hospital and from patients referred to the Physical Medicine and Rehabilitation outpatient clinic. Eligible participants will undergo clinical evaluation during a single study visit.
Key inclusion criteria (5 listed)
- Diagnosis of multiple sclerosis according to the 2024 McDonald criteria
- Age ≥ 18 years
- Presence of clinical spasticity defined as Modified Ashworth Scale score ≥ 1 in at least one joint
- Ability to understand study procedures and provide informed consent
- Absence of significant cognitive impairment
Key exclusion criteria (6 listed)
- Presence of orthopedic, rheumatologic, or neurological conditions affecting movement other than multiple sclerosis
- Botulinum toxin type A injection within the previous 3 months
- Previous surgical treatment for upper extremity spasticity
- Bone deformities affecting the upper extremity
- Inability or unwillingness to provide informed consent
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 |
|---|---|---|
| Observational AssessmentThis is an observational study without therapeutic intervention. Participants will undergo clinical assessment of spasticity patterns, functional performance tests, and patient-reported outcome measures during a single study visit. | Other | Multiple Sclerosis With Spasticity |
Primary outcome
Classification of Upper and Lower Extremity Spasticity Patterns
Time frame: Baseline (single study visit)
Upper and lower extremity spasticity patterns will be classified based on limb postures and spasticity severity assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive muscle stretching and is scored from 0 to 4 (0 = no increase in muscle tone; 1 = slight increase in muscle tone; 1+ = slight increase in tone with minimal resistance through less than half of the range of motion; 2 = more marked increase in tone through most of the range of motion; 3 = considerable increase in muscle tone; 4 = affected part rigid in flexion or extension). Higher scores indicate greater spasticity. Spasticity will be evaluated at the shoulder, elbow, forearm, wrist, and hand for the upper extremity and at the hip, knee, and ankle for the lower extremity. Based on these assessments, patients will be categorized according to their upper and lower extremity spasticity patterns.
4 secondary outcomes
Impact of Spasticity on Quality of Life
Time frame: Baseline (single study visit)
Lower Extremity Functional Performance
Time frame: Baseline (single study visit)
Upper Extremity Manual Dexterity
Time frame: Baseline (single study visit)
Spasticity Severity Assessed by the Modified Ashworth Scale
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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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.
Evrim Karadag Saygi contact
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 and Spasticity, run by Marmara 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 5 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Saika Kahvecioglu Atabay (+90 5346588929, saikakahvecioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of Upper and Lower Extremity Spasticity Patterns (time frame: Baseline (single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.