Multiple SclerosisNCT03706131
The Effect of Cervical Mobilization on Balance and Spasticity in Multiple Sclerosis Individuals
A study testing cervical mobilisation in people with Multiple Sclerosis and Balance; Distorted, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Taking into consideration the effects of mobilization on muscle tone and balance, it is predicted that this method will have effective results in the treatment of individuals with MS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Balance; Distorted
- What is being tested?
- cervical mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 Apr 2021
- Phase
- Interventional
- 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
Who may be able to join
- Expanded Disability Status Scale (EDSS) score between 2-5,
- The EDSS Cerebellar System Subscale has a Functional System Score of ˃0,
- At least one of the hip extender, Gastro-soleus and Quadriceps Femoris muscles has a spasticity of ≤2 according to the Modifiye Ashworth scale (MAS)
- If the medical condition is stable and there is no drug change in the last month,
- Vertebro-bacillus test is negative,
- have no other orthopedic problems to prevent further neurological distress and participation in the study,
- At least 24 points from the Mini Mental Test,
- They are designated as volunteers to participate in the study. -
Who cannot join
- Under age 18 and older than 65 years
- The Expanded Disability Status Scale (EDSS) score is less than 2, higher than 5,
- The EDSS Cerebellar System Subscale has a Functional System Score of 0,
- The spasticity values of the hip extender, Gastro-soleus and Quadriceps Femoris muscles are ˃2 according to the Modifiye Ashworth scale (MAS)
- The cognitive problem is that the Mini Mental Test score is below 24,
- The existence of cardiovascular, orthopedic, psychological and other problems that may prevent the completion of the assessments,
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- Vertebro-bacillus test is positive,
- plaque presence of cervical and thoracal region demyelination,
- Having had an attack within the last 3 months,
- Botulinum toxin administration in the last 6 months,
- Has been admitted to the physiotherapy program in the last six months -
Trial locations and contacts
1 site in 1 country.
About this study
Taking into consideration the effects of mobilization on muscle tone and balance, it is predicted that this method will have effective results in the treatment of individuals with MS. Therefore, it is thought that grade A and grade B mobilization applications can be used to strengthen the balance control mechanisms of MS individuals and to regulate muscle tone by increasing the proprioceptive input. In this study, it was aimed to investigate the short-term effects of cervical mobilization on balance and spasticity in MS individuals.
Read the detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating, and neurodegenerative disease of the central nervous system (CNS). The etiology of the disease is not fully known. It is thought that both autoimmune and neurodegenerative mechanisms can play a role in MS. Genetic and environmental factors are also influenced by the emergence of the disease. Although the factors that trigger MS are not fully known, autoreactive T cells and antibodies against SSS are thought to have a major pathogenic role in the development of inflammation and tissue damage. The same mechanism is held responsible for the progression of neurological disorders and functional deficits.
MS can severely limit the quality of life in patients due to the accumulation of sequelae following the attacks or the development of a progressive degenerative process, leading to progressive disability.
The disease has marked clinical heterogeneity. This difference may be in the age of onset, onset, frequency, severity and sequelae of exacerbations, worsening prevalence and cumulative impairment over time. Although there are differences in clinical and pathologic findings, variable clinical features reflect multifocal SSS destruction. In patients, somatosensory findings (burning, numbness, tingling, deep and superficial sensory deficits), motor findings (spasticity due to corticospinal involvement, muscle strength losses), postural control and coordination disorders, bladder-bowel problems, visual, cognitive and psychiatric manifestations, fatigue and sleep disorders.
Spasticity is one of the most common physical disorders in MS. It is known that 60-90% of individuals with MS develop spasticity. MS-associated spasticity; generalized, focal (which affects a part of the extremity) or multifocal (which affects more than one part of the extremities or extremities). Spasticity; due to force imbalance between agonist and antagonist muscles, affecting static joint positions and dynamic limb movements, resulting in abnormal postural conditions and stiffness. Spasticity is directly related to disease progression and muscle weakness leads to secondary fatigue due to increased energy expenditure. Depending on the spasticity, structural changes of muscles, tendons and joints affect the movements and functions of the extremities.
Equilibrium losses are one of the other important symptoms seen in MS patients, affecting about 75% of patients. Balance; the ability to keep the center of gravity of the body within the limits of the support surface. The sensory components of the balance; visual, vestibular and somatosensory system information. The feeling of proprioception, which is part of the somatosensory system; joints and extremities, which are formed by receptors located in the joints and tissues and provided by neural inputs. Proprioceptors are specific receptors that are located at different rates in different structures and tissues of the body. It is known that the cervical region is very rich in these receptors. In this respect, the neck plays a very important role in maintaining the right orientation, balance, and accordingly motor coordination of the whole body. For example; In the impaired proprioceptive processes of the lower extremities, compensation is provided by proprioceptive inputs from the cervical region to maintain body balance. The cervical region is closely related to the vestibular system, which is another sensory component of balance. This relationship is extremely important in the activity of cervico-colic (CCR) and vestibulo-colic reflexes (VCR). VCR is semicircular canal and macular origin. They are effective on the receptors on the inner ear and on the muscular extensor muscles. In one study, when vestibular stimulation accompanied the tension of the neck muscles, the sagittal VCR in the semispinalis capitis muscle increased about three-fold normally. Strengthening of the VCR reflex with tongue proprioceptive afferents is the result of summing up of CCR and VCR induced by stretching of the neck muscles. The interaction between the two reflexes showed that not only the vestibular stimulation but also the length of the neck muscles were important in the normal movement of the head over the neck.
In the treatment of spasticity and balance disorders, which are very common and difficult to manage in MS patients, drug therapies, botulinum toxin treatments, surgical treatments and physiotherapy and rehabilitation approaches are included.Physiotherapy applications; sensory, walking parameters, extremity functions, muscle tone, body and standing balance are known to have positive effects. The use of somatosensory strategies, balance exercises, coordination training, spinal stabilization exercises and activity based exercises are the physiotherapy approaches used in balance training. Mobilization techniques, which are another physiotherapy application, restoration of joint motion with the application of different forms of active and passive exercise. Mobilization is a repetitive passive motion within the limits of normal joint motion, without exceeding this limit, at different amplitudes at low speeds. The neurophysiological effects of mobilization are to improve the proprioception sensation by stimulating receptor nerve endings in different periarticular structures, changing the range of motion, pain, muscle tone, motor control and spinal stability. Inserted stretching and pushing stimulates Type III joint receptors and golgi tendon organs. In this case relaxation occurs with temporary inhibition in the muscles. This causes an increase in joint motion and prepares the joint for more stretching and mobilization. Thus, pain and protective muscle spasm are reduced. Neurophysiological effects of mobilization; decreased pain and muscle tone, postural control and balance effects.
Mobilization techniques are classified into 3 groups according to severity and degree. These; grade A (mobilization), grade B (mobilization) and grade C (manipulation). Grade (mobility); active, or active assisted movements within painless range of motion. Grade B (mobility); is a special continuous stretching technique which causes the prolongation of the connector touch. At the spinal joints, the joint is applied at the end of the range of motion. Grade C (manipulation); passive movement in the form of a minimal amplitude, high velocity push applied between the physiological boundary and the anatomical boundary.
Taking into consideration the effects of mobilization on muscle tone and balance, it is predicted that this method will have effective results in the treatment of individuals with MS. Therefore, it is thought that grade A and grade B mobilization applications can be used to strengthen the balance control mechanisms of MS individuals and to regulate muscle tone by increasing the proprioceptive input. In this study, it was aimed to investigate the short-term effects of cervical mobilization on balance and spasticity in MS individuals.
- Conditions
- Multiple Sclerosis, Balance; Distorted
- Being tested
- cervical mobilisation
- Keywords
- multiple sclerosis, cervical region, balance, spasticity, mobilisation
- 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.
cervical mobilisationOther
manual therapy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | one session 15 minutes cervical mobilisation and home exercise Receives: Other: cervical mobilisation |
| control grup | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Dynamic Posturography
balance assessment
Measured: 30 minutes
Secondary outcomes (3)
Berg Balance Scale
The BBS is a 14-item scale that was designed to measure balance in the elderly population in a clinical setting. It has also been used to assess postural balance in people with a history of stroke and traumatic brain injury. The BBS consists of 14 different tests examining individuals' ability to sit, stand, reach, maintain single-leg stance, and turn. It rates performance on a scale from 0 (cannot perform task) to 4 (normal performance on task). In the elderly population, it has been found to be a good predictor of falling, with good validity and reliability.The total possible score ranges from 0 to 56; a score of 45 or below indicates an increased risk of falling.
Measured: 7 minutes
Range of Motion
Goniometric measurements are used by physical therapists to quantify baseline limitations of motion, decide on appro- priate therapeutic interventions, and document the effectiveness of these interventions. This assessment is used for spasticity evaluation.
Measured: 10 minutes
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) measures resistance during passive soft-tissue stretching. It is a quick and easy measure that can help assess the efficacy of treatment.
Scoring 0 = Normal tone, no increase in tone 1 = Slight increase in muscle tone, manifested by a catch and release or minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension
1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2= More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3= Considerable increase in muscle tone, passive movement difficult 4=Affected part(s) rigid in flexion or extension.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Apr 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ECEM KARANFİL, Hacettepe University
- Investigators
- Kadriye armutlu, prof.dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706131
- Sponsor's protocol ID
- KA-17087
- Status last verified
- May 2021
- First submitted
- 9 Aug 2018
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karlberg M, Magnusson M, Malmstrom EM, Melander A, Moritz U. Postural and symptomatic improvement after physiotherapy in patients with dizziness of suspected cervical origin. Arch Phys Med Rehabil. 1996 Sep;77(9):874-82. doi: 10.1016/s0003-9993(96)90273-7.
PubMed 8822677
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cervical Mobilization on Balance and Spasticity in Multiple Sclerosis Individuals
- ClinicalTrials.gov ID
- NCT03706131
- Acronym / sponsor ID
- KA-17087
- Conditions
- Multiple Sclerosis, Balance; Distorted
- Keywords
- multiple sclerosis, cervical region, balance, spasticity, mobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 15 Oct 2018 (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.
Taking into consideration the effects of mobilization on muscle tone and balance, it is predicted that this method will have effective results in the treatment of individuals with MS. Therefore, it is thought that grade A and grade B mobilization applications can be used to strengthen the balance control mechanisms of MS individuals and to regulate muscle tone by increasing the proprioceptive input. In this study, it was aimed to investigate the short-term effects of cervical mobilization on balance and spasticity in MS individuals.
Detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating, and neurodegenerative disease of the central nervous system (CNS). The etiology of the disease is not fully known. It is thought that both autoimmune and neurodegenerative mechanisms can play a role in MS. Genetic and environmental factors are also influenced by the emergence of the disease. Although the factors that trigger MS are not fully known, autoreactive T cells and antibodies against SSS are thought to have a major pathogenic role in the development of inflammation and tissue damage. The same mechanism is held responsible for the progression of neurological disorders and functional deficits.
MS can severely limit the quality of life in patients due to the accumulation of sequelae following the attacks or the development of a progressive degenerative process, leading to progressive disability.
The disease has marked clinical heterogeneity. This difference may be in the age of onset, onset, frequency, severity and sequelae of exacerbations, worsening prevalence and cumulative impairment over time. Although there are differences in clinical and pathologic findings, variable clinical features reflect multifocal SSS destruction. In patients, somatosensory findings (burning, numbness, tingling, deep and superficial sensory deficits), motor findings (spasticity due to corticospinal involvement, muscle strength losses), postural control and coordination disorders, bladder-bowel problems, visual, cognitive and psychiatric manifestations, fatigue and sleep disorders.
Spasticity is one of the most common physical disorders in MS. It is known that 60-90% of individuals with MS develop spasticity. MS-associated spasticity; generalized, focal (which affects a part of the extremity) or multifocal (which affects more than one part of the extremities or extremities). Spasticity; due to force imbalance between agonist and antagonist muscles, affecting static joint positions and dynamic limb movements, resulting in abnormal postural conditions and stiffness. Spasticity is directly related to disease progression and muscle weakness leads to secondary fatigue due to increased energy expenditure. Depending on the spasticity, structural changes of muscles, tendons and joints affect the movements and functions of the extremities.
Equilibrium losses are one of the other important symptoms seen in MS patients, affecting about 75% of patients. Balance; the ability to keep the center of gravity of the body within the limits of the support surface. The sensory components of the balance; visual, vestibular and somatosensory system information. The feeling of proprioception, which is part of the somatosensory system; joints and extremities, which are formed by receptors located in the joints and tissues and provided by neural inputs. Proprioceptors are specific receptors that are located at different rates in different structures and tissues of the body. It is known that the cervical region is very rich in these receptors. In this respect, the neck plays a very important role in maintaining the right orientation, balance, and accordingly motor coordination of the whole body. For example; In the impaired proprioceptive processes of the lower extremities, compensation is provided by proprioceptive inputs from the cervical region to maintain body balance. The cervical region is closely related to the vestibular system, which is another sensory component of balance. This relationship is extremely important in the activity of cervico-colic (CCR) and vestibulo-colic reflexes (VCR). VCR is semicircular canal and macular origin. They are effective on the receptors on the inner ear and on the muscular extensor muscles. In one study, when vestibular stimulation accompanied the tension of the neck muscles, the sagittal VCR in the semispinalis capitis muscle increased about three-fold normally. Strengthening of the VCR reflex with tongue proprioceptive afferents is the result of summing up of CCR and VCR induced by stretching of the neck muscles. The interaction between the two reflexes showed that not only the vestibular stimulation but also the length of the neck muscles were important in the normal movement of the head over the neck.
In the treatment of spasticity and balance disorders, which are very common and difficult to manage in MS patients, drug therapies, botulinum toxin treatments, surgical treatments and physiotherapy and rehabilitation approaches are included.Physiotherapy applications; sensory, walking parameters, extremity functions, muscle tone, body and standing balance are known to have positive effects. The use of somatosensory strategies, balance exercises, coordination training, spinal stabilization exercises and activity based exercises are the physiotherapy approaches used in balance training. Mobilization techniques, which are another physiotherapy application, restoration of joint motion with the application of different forms of active and passive exercise. Mobilization is a repetitive passive motion within the limits of normal joint motion, without exceeding this limit, at different amplitudes at low speeds. The neurophysiological effects of mobilization are to improve the proprioception sensation by stimulating receptor nerve endings in different periarticular structures, changing the range of motion, pain, muscle tone, motor control and spinal stability. Inserted stretching and pushing stimulates Type III joint receptors and golgi tendon organs. In this case relaxation occurs with temporary inhibition in the muscles. This causes an increase in joint motion and prepares the joint for more stretching and mobilization. Thus, pain and protective muscle spasm are reduced. Neurophysiological effects of mobilization; decreased pain and muscle tone, postural control and balance effects.
Mobilization techniques are classified into 3 groups according to severity and degree. These; grade A (mobilization), grade B (mobilization) and grade C (manipulation). Grade (mobility); active, or active assisted movements within painless range of motion. Grade B (mobility); is a special continuous stretching technique which causes the prolongation of the connector touch. At the spinal joints, the joint is applied at the end of the range of motion. Grade C (manipulation); passive movement in the form of a minimal amplitude, high velocity push applied between the physiological boundary and the anatomical boundary.
Taking into consideration the effects of mobilization on muscle tone and balance, it is predicted that this method will have effective results in the treatment of individuals with MS. Therefore, it is thought that grade A and grade B mobilization applications can be used to strengthen the balance control mechanisms of MS individuals and to regulate muscle tone by increasing the proprioceptive input. In this study, it was aimed to investigate the short-term effects of cervical mobilization on balance and spasticity in MS individuals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: cervical mobilisationone session 15 minutes cervical mobilisation and home exercise |
| control grup | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Expanded Disability Status Scale (EDSS) score between 2-5,
- The EDSS Cerebellar System Subscale has a Functional System Score of ˃0,
- At least one of the hip extender, Gastro-soleus and Quadriceps Femoris muscles has a spasticity of ≤2 according to the Modifiye Ashworth scale (MAS)
- If the medical condition is stable and there is no drug change in the last month,
- Vertebro-bacillus test is negative,
Key exclusion criteria (11 listed)
- Under age 18 and older than 65 years
- The Expanded Disability Status Scale (EDSS) score is less than 2, higher than 5,
- The EDSS Cerebellar System Subscale has a Functional System Score of 0,
- The spasticity values of the hip extender, Gastro-soleus and Quadriceps Femoris muscles are ˃2 according to the Modifiye Ashworth scale (MAS)
- The cognitive problem is that the Mini Mental Test score is below 24,
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 |
|---|---|---|
| cervical mobilisationmanual therapy | Other | experimental group |
Primary outcome
Computerized Dynamic Posturography
Time frame: 30 minutes
balance assessment
3 secondary outcomes
Berg Balance Scale
Time frame: 7 minutes
Range of Motion
Time frame: 10 minutes
Modified Ashworth Scale
Time frame: 10 minutes
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 10 May 2021.
- Results publication: PubMed 8822677Karlberg M, Magnusson M, Malmstrom EM, Melander A, Moritz U. Postural and symptomatic improvement after physiotherapy in patients with dizziness of suspected cervical origin. Arch Phys Med Rehabil. 1996 Sep;77(9):874-82. doi: 10.1016/s0003-9993(96)90273-7.
- pubmedLink provided by the sponsor.
- 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.
Kadriye armutlu, prof.dr. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical mobilisation in people with Multiple Sclerosis and Balance; Distorted, 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 8 inclusion and 11 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 10 May 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?
Computerized Dynamic Posturography (time frame: 30 minutes). 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 NCT03706131, which also lists 1 linked publication.
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 10 May 2021.