Multiple SclerosisNCT04543448
Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis
A study testing Traditional Rehabilitation for multiple sclerosis and Cervical mobilization for multiple sclerosis in people with Multiple Sclerosis and Muscle Spasticity, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
MS patients were randomly divided into traditional therapy and traditional therapy + cervical mobilization groups. While muscle strengthening, stretching, balance and coordination exercises were given to the traditional group, cervical mobilization was applied in addition to these in cervical group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Muscle Spasticity, Pressure Area
- What is being tested?
- Traditional Rehabilitation for multiple sclerosis and Cervical mobilization for multiple sclerosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2019to 20 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expanded Disability Status Scale (EDSS) score was between 2-5,
- According to the modified Ashworth Scale, spasticity is between 1 and 3,
- EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
- medical condition is stable and no medication changes were made in the last month,
- Vertebro-basillar test negative,
- Not have any other neurological disorder and orthopedic problem to prevent participation in this study
- A score of at least 24 from the Mini Mental Test,
Who cannot join
- presence of psychiatric or severe cognitive dysfunction,
- pregnancy,
- Having a neurological disease other than MS,
- having had an attack in the last 3 months,
- Botulinum toxin application within the last 6 months,
- participating in physiotherapy program in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation the Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis Patients: A Randomized Crossover Controlled Study
MS patients were randomly divided into traditional therapy and traditional therapy + cervical mobilization groups. While muscle strengthening, stretching, balance and coordination exercises were given to the traditional group, cervical mobilization was applied in addition to these in cervical group. Patients received treatments twice a week for 4 weeks. The effect of the applied treatment on the tonus and plantar pressure distribution was analyzed. Treatments were interrupted for 4 weeks and the groups continued with the treatment they did not receive (crossover design). The group that received traditional treatment in the first period completed traditional + cervical mobilization, and the other group with traditional + cervical mobilization traditionally completed the treatment.
Read the detailed description
Cervical region is rich in terms of muscle spindle and reseptors. When this region is touched by physiotherapists, muscle spindles is activited. The cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to improvement of balance. As improve balance, the plantar pressure distribution of patients may change.
- Being tested
- Traditional Rehabilitation for multiple sclerosis, Cervical mobilization for multiple sclerosis
- Keywords
- cervical region, multiple sclerosis, muscle spasticity, manual therapy, cervical spine, Plantar pressure
- 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.
Traditional Rehabilitation for multiple sclerosisOther
Also called traditional rehabilitation
Traditional rehabilitation program include strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs.
Cervical mobilization for multiple sclerosisOther
Also called traditional rehabilitation+ cervical mobilization
Cervical mobilization program include myofascial relaxation techniques and mobilization to cervical spine in addition to traditional program.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Rehabilitation | Other | Traditional Rehabilitation program was included strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs in all individuals. Indıvıduals participated in 2 training sessions per week for 4 weeks. Each training session consisted of a 5-minute non-balance coordination exercise, a 30-minute balance and coordination exercise, a 10-minute stretching and strengthing. Receives: Other: Traditional Rehabilitation for multiple sclerosis |
| Cervical Mobilization | Experimental | Cervical Mobilization program, cervical mobilization techniques were applied to the patients for 30 minutes in addition to the traditional program. Cervical mobilization includes suboccipital relaxing techniques, myofascial muscle relaxing techniques for Levator scapula, trapezius, scalenes muscles. These techniques were applied bilaterally. Receives: Other: Cervical mobilization for multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Plantar Pressure Distribution
Pedobarography system was used for plantar pressure analyses. Pedobarography system contains screen, color printer, pressure sensor platform, remote control device, power unit, printer-to-platform and screen-to-platform connections. The maximum and mean pressure in the foot, the percentages of pressure values in the fore and rear of the foot, percentages of the total pressure falling to the foot were evaluated. As higher values mean higher load.
Measured: Change from plantar pressure distribution at one month
Change Balance
Romberg test (RT) was performed on the patients with eyes closed and feet together. When the participant held it in one place, the test was terminated, oscillations began, or was likely to fall. Romberg test's maximum duration was 120 sec. RT is clinically used for vestibular problems.
Sharpened Romberg (SR) was performed on a straight line with one leg behind the other leg, eyes open, leaving the arms sagging and without impairing the balance. Duration stop criteria were defined as the time that took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling.
Individuals' dynamic balance was evaluated with the Functional Reach Test (FRT). Individuals had requested their hands at 90 degrees by keeping the dominant arms' elbow straight on the wall. The test was performed as reaching forward without taking a step and losing the balance on the wall. The metacarpal bone level was marked in the start position and final position
Measured: Change from plantar pressure distribution at one month
Secondary outcomes (1)
Change Modified ashworth scale
Modified Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. The minimum value is 1 and the maximum value is 4. Whether higher scores mean a worse outcome
Measured: Change from Modified ashworth scale at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start2 Oct 2019
- Primary completion31 May 2020
- Study completion20 Aug 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are grouped randomly. First group and second group are applied different rehabilitation programs. Both of group is rest four weeks. Than second group is applied first group's rehabilitation program and first group is applied second group's rehabilitation program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Maden, Hasan Kalyoncu University
- Investigators
- KEZBAN BAYRAMLAR, Prof. Dr., Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543448
- Sponsor's protocol ID
- 2019/0107
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Effect of Cervical Mobilization on Balance and Plantar Pressure Distribution in Multiple Sclerosis Patients: A Randomized Crossover Controlled Study
- ClinicalTrials.gov ID
- NCT04543448
- Acronym / sponsor ID
- 2019/0107
- Keywords
- cervical region, multiple sclerosis, muscle spasticity, manual therapy, cervical spine, Plantar pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 10 Sep 2020 (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.
MS patients were randomly divided into traditional therapy and traditional therapy + cervical mobilization groups. While muscle strengthening, stretching, balance and coordination exercises were given to the traditional group, cervical mobilization was applied in addition to these in cervical group. Patients received treatments twice a week for 4 weeks. The effect of the applied treatment on the tonus and plantar pressure distribution was analyzed. Treatments were interrupted for 4 weeks and the groups continued with the treatment they did not receive (crossover design). The group that received traditional treatment in the first period completed traditional + cervical mobilization, and the other group with traditional + cervical mobilization traditionally completed the treatment.
Detailed description
Cervical region is rich in terms of muscle spindle and reseptors. When this region is touched by physiotherapists, muscle spindles is activited. The cervical region is parasympathetic area have common relaxed effect. Thus this part can be benefit to improvement of balance. As improve balance, the plantar pressure distribution of patients may change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are grouped randomly. First group and second group are applied different rehabilitation programs. Both of group is rest four weeks. Than second group is applied first group's rehabilitation program and first group is applied second group's rehabilitation program.
| Arm | Type | Receives |
|---|---|---|
| Traditional Rehabilitation | Other | Other: Traditional Rehabilitation for multiple sclerosisTraditional Rehabilitation program was included strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs in all individuals. Indıvıduals participated in 2 training sessions per week for 4 weeks. Each training session consisted of a 5-minute non-balance coordination exercise, a 30-minute balance and coordination exercise, a 10-minute stretching and strengthing. |
| Cervical Mobilization | Experimental | Other: Cervical mobilization for multiple sclerosisCervical Mobilization program, cervical mobilization techniques were applied to the patients for 30 minutes in addition to the traditional program. Cervical mobilization includes suboccipital relaxing techniques, myofascial muscle relaxing techniques for Levator scapula, trapezius, scalenes muscles. These techniques were applied bilaterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Expanded Disability Status Scale (EDSS) score was between 2-5,
- According to the modified Ashworth Scale, spasticity is between 1 and 3,
- EDSS Cerebellar System Sub-Scale, Functional System Score ˃1,
- medical condition is stable and no medication changes were made in the last month,
- Vertebro-basillar test negative,
Key exclusion criteria (6 listed)
- presence of psychiatric or severe cognitive dysfunction,
- pregnancy,
- Having a neurological disease other than MS,
- Botulinum toxin application within the last 6 months,
- participating in physiotherapy program in the last 6 months
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 |
|---|---|---|
| Traditional Rehabilitation for multiple sclerosisAlso: traditional rehabilitationTraditional rehabilitation program include strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs. | Other | Traditional Rehabilitation |
| Cervical mobilization for multiple sclerosisAlso: traditional rehabilitation+ cervical mobilizationCervical mobilization program include myofascial relaxation techniques and mobilization to cervical spine in addition to traditional program. | Other | Cervical Mobilization |
Primary outcome
Change Plantar Pressure Distribution
Time frame: Change from plantar pressure distribution at one month
Pedobarography system was used for plantar pressure analyses. Pedobarography system contains screen, color printer, pressure sensor platform, remote control device, power unit, printer-to-platform and screen-to-platform connections. The maximum and mean pressure in the foot, the percentages of pressure values in the fore and rear of the foot, percentages of the total pressure falling to the foot were evaluated. As higher values mean higher load.
Change Balance
Time frame: Change from plantar pressure distribution at one month
Romberg test (RT) was performed on the patients with eyes closed and feet together. When the participant held it in one place, the test was terminated, oscillations began, or was likely to fall. Romberg test's maximum duration was 120 sec. RT is clinically used for vestibular problems. Sharpened Romberg (SR) was performed on a straight line with one leg behind the other leg, eyes open, leaving the arms sagging and without impairing the balance. Duration stop criteria were defined as the time that took a participant to dislocate the foot, reach the maximal duration of 30 sec, and contact the observer to avoid falling. Individuals' dynamic balance was evaluated with the Functional Reach Test (FRT). Individuals had requested their hands at 90 degrees by keeping the dominant arms' elbow straight on the wall. The test was performed as reaching forward without taking a step and losing the balance on the wall. The metacarpal bone level was marked in the start position and final position
1 secondary outcome
Change Modified ashworth scale
Time frame: Change from Modified ashworth scale at one month
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 22 Jan 2021.
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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.
KEZBAN BAYRAMLAR, Prof. Dr. study director
Hasan Kalyoncu 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 Traditional Rehabilitation for multiple sclerosis and Cervical mobilization for multiple sclerosis in people with Multiple Sclerosis and Muscle Spasticity, run by Hasan Kalyoncu 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 7 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 22 Jan 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?
Change Plantar Pressure Distribution (time frame: Change from plantar pressure distribution at one month). The study lists 2 primary outcomes in all. 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 22 Jan 2021.