- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07648277
Spinal Alignment, Spinal Mobility, and Balance in Patients With Multiple Sclerosis
Relationship Between Spinal Alignment, Spinal Mobility, and Balance in Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system characterized by demyelination and axonal degeneration. Neuromuscular impairments associated with MS, including muscle weakness, spasticity, fatigue, and proprioceptive deficits, may lead to alterations in spinal posture and reduced spinal mobility. These changes can negatively affect trunk control, balance, respiratory function, and functional independence.
Although postural abnormalities and mobility limitations have been reported in individuals with MS, the relationship between spinal posture, spinal mobility, and balance remains insufficiently investigated. Therefore, this study aims to examine the associations between spinal posture, spinal mobility, and balance performance in individuals with multiple sclerosis. Improved understanding of these relationships may contribute to the development of targeted rehabilitation interventions aimed at enhancing postural control and functional outcomes in this population. This study further hypothesises that alterations in spinal posture and spinal mobility are associated with impaired balance performance in individuals with multiple sclerosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Çubuk
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Ankara, Çubuk, Turkey (Türkiye), 06760
- Recruiting
- Ankara Yıldırım Beyazıt University
-
Contact:
- Yasemin Ateş Sarı
- Phone Number: 05397799535
- Email: yaseminates48@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- Aged between 18 and 65 years
- EDSS score between 0.5 and 4.5
- Standardized Mini-Mental State Examination score ≥24
Exclusion Criteria:
- Receipt of corticosteroid treatment within the previous 4 weeks
- Presence of any additional neurological disorder
- Spasticity defined as a Modified Ashworth Scale score ≥3
- History of surgical intervention involving the lower extremities, spine, or abdominal region
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Multiple Sclerosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinal alignment
Time Frame: 1 hour
|
Spinal alignment was assessed in the sagittal and frontal planes during neutral standing, maximal trunk flexion, and maximal trunk extension.
All spinal alignment parameters were recorded as angular values and expressed in degrees (°).
|
1 hour
|
|
Spinal mobility
Time Frame: 1 hour
|
Spinal mobility was assessed in both the sagittal and frontal planes.
In the sagittal plane, mobility was calculated as the angular difference between the neutral standing posture and maximal trunk flexion and extension positions.
In the frontal plane, lateral flexion mobility was calculated as the angular difference between the neutral standing posture and maximal right and left lateral flexion positions.
All measurements were recorded in degrees (°).
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single-Leg Stance
Time Frame: 1 hour
|
Single-leg stance time was recorded in seconds, with shorter durations indicating poorer balance performance.
|
1 hour
|
|
Time Up and Go
Time Frame: 1 hour
|
Dynamic balance was assessed using the Timed Up and Go test.
Performance was recorded as the time required to complete the task (seconds), with longer times indicating poorer dynamic balance.
|
1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/1456
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
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University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
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BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
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Cabaletta BioNot yet recruitingProgressive Multiple Sclerosis | Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Relapsing Multiple Sclerosis (RMS) | Progressive Multiple Sclerosis (PMS) | Multiple Sclerosis (MS) - Relapsing-remitting | Multiple Sclerosis - Relapsing Remitting
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple Sclerosis | Active Secondary Progressive Multiple SclerosisJapan
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; University of Copenhagen and other collaboratorsActive, not recruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark