Multiple SclerosisNCT04192786
Local Vibration in Multiple Sclerosis Patients
A study testing Standard physiotherapy program+50 Hz local vibration, Standard physiotherapy program+100 Hz local vibration and Standard physiotherapy program in people with Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Gastrocnemius spasticity is one of the main complaints in Multiple Sclerosis patients.Local muscle vibration is a method used for spasticity inhibition. However, when the studies in the literature are examined; It is noted that local vibration applications for spasticity are usually single sessions and evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Standard physiotherapy program+50 Hz local vibration, Standard physiotherapy program+100 Hz local vibration and Standard physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2019to Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- EDSS<5,5
- Gastrocnemius spasticity<2
Who cannot join
- having any injury or surgery of the lower extremity
- having systemic and metabolic disease
- having behavioral and cognitive problems that prevent consistence to guidelines given
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, Altındağ, 06100
Muhammed Kılınç, Assoc. Prof., +905326418381, muhammedkilinc@yahoo.com
About this study
Official title: The Effect of Local Vibration Applied to Spastic Gastrocnemius on Muscle Architecture and Functional Properties in Multiple Sclerosis Patients
Gastrocnemius spasticity is one of the main complaints in Multiple Sclerosis patients.Local muscle vibration is a method used for spasticity inhibition. However, when the studies in the literature are examined; It is noted that local vibration applications for spasticity are usually single sessions and evaluate the acute effect, do not produce functional outputs, there is no consensus on frequency and amplitude and the changes in muscle architecture are not examined. In this study, we aimed to investigate the effect of local vibration applied on spastic gastrocnemius on muscle architectural and functional properties in Multiple Sclerosis patients in addition to the standard physiotherapy program. The study was planned to include 3 groups, 2 treatment and 1 control group. The control group will receive standard physiotherapy, one of the treatment groups will receive 50 Hz local vibration in addition to standard physiotherapy, and other treatment group will receive 100 Hz local vibration in addition to standard physiotherapy. Disease severity, gastrocnemius spasticity, architectural and viscoelastic properties of muscle, ankle proprioception, balance and gait skills will be evaluated before and after 8 weeks treatment program. As a result; effectiveness of local vibration in addition to standard physiotherapy program and whether there is a difference between applications at different frequencies will be examined.
- Conditions
- Multiple Sclerosis
- Being tested
- Standard physiotherapy program+50 Hz local vibration, Standard physiotherapy program+100 Hz local vibration, Standard physiotherapy program
- Keywords
- Multiple Sclerosis, Spasticity, Local Vibration, Muscle Architecture, Functionality
- 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.
Standard physiotherapy program+50 Hz local vibrationOther
Standard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (50 Hz) for 10 minutes will be performed 3 days a week for 8 weeks.
Standard physiotherapy program+100 Hz local vibrationOther
Standard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (100 Hz) for 10 minutes will be performed 3 days a week for 8 weeks.
Standard physiotherapy programOther
Standard physiotherapy program (strength, balance, gait exercises) for 60 minutes will be performed 3 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 50 Hz | Experimental | Not described Receives: Other: Standard physiotherapy program+50 Hz local vibration |
| Treatment Group 100 Hz | Experimental | Not described Receives: Other: Standard physiotherapy program+100 Hz local vibration |
| Control Group | Active comparator | Not described Receives: Other: Standard physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography
Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Muscle Thickness and Fascicle Length would be expressed as centimeters.
Measured: 3 minutes
Evaluation of Pennation Angle with Ultrasonography
Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Pennation Angle would be angularly indicated.
Measured: 2 minutes
Secondary outcomes (6)
Assessment of spasticity
Modified Ashworth Scale (minimum score 0 (worse), maximum score 4 (better))
Measured: 5 minutes
Assessment of viscoelastic properties of muscle
Myoton-3 (assessment of tone, elasticity and stiffness)
Measured: 5 minutes
Assessment of ankle proprioception
Isokinetic dynamometer (Isomed 2000) (passive ankle joint position sense)
Measured: 5 minutes
Assessment of single leg balance
Single leg balance test
Measured: 3 minutes
Assessment of balance
Bertec Balance Check ScreenerTM force platform system (Assessment of limits of stability, anteroposterior and mediolateral sway range)
Measured: 10 minutes
Assessment of gait characterictics
GAITRite Analysis System (assessment of velocity, step length, percentage of gait cycle spent in double and single support, stance phase, swing phase, base of support)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Dec 2019
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ayvat, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192786
- Sponsor's protocol ID
- KA-19018
- Status last verified
- Jun 2020
- First submitted
- 26 Nov 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayvat F, Ozcakar L, Ayvat E, Aksu Yildirim S, Kilinc M. Effects of low vs. high frequency local vibration on mild-moderate muscle spasticity: Ultrasonographical and functional evaluation in patients with multiple sclerosis. Mult Scler Relat Disord. 2021 Jun;51:102930. doi: 10.1016/j.msard.2021.102930. Epub 2021 Mar 31.
PubMed 33836458
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Vibration Applied to Spastic Gastrocnemius on Muscle Architecture and Functional Properties in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04192786
- Acronym / sponsor ID
- KA-19018
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Spasticity, Local Vibration, Muscle Architecture, Functionality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Dec 2019 (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.
Gastrocnemius spasticity is one of the main complaints in Multiple Sclerosis patients.Local muscle vibration is a method used for spasticity inhibition. However, when the studies in the literature are examined; It is noted that local vibration applications for spasticity are usually single sessions and evaluate the acute effect, do not produce functional outputs, there is no consensus on frequency and amplitude and the changes in muscle architecture are not examined. In this study, we aimed to investigate the effect of local vibration applied on spastic gastrocnemius on muscle architectural and functional properties in Multiple Sclerosis patients in addition to the standard physiotherapy program. The study was planned to include 3 groups, 2 treatment and 1 control group. The control group will receive standard physiotherapy, one of the treatment groups will receive 50 Hz local vibration in addition to standard physiotherapy, and other treatment group will receive 100 Hz local vibration in addition to standard physiotherapy. Disease severity, gastrocnemius spasticity, architectural and viscoelastic properties of muscle, ankle proprioception, balance and gait skills will be evaluated before and after 8 weeks treatment program. As a result; effectiveness of local vibration in addition to standard physiotherapy program and whether there is a difference between applications at different frequencies will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 50 Hz | Experimental | Other: Standard physiotherapy program+50 Hz local vibration |
| Treatment Group 100 Hz | Experimental | Other: Standard physiotherapy program+100 Hz local vibration |
| Control Group | Active comparator | Other: Standard physiotherapy program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years
- EDSS<5,5
- Gastrocnemius spasticity<2
Key exclusion criteria (3 listed)
- having any injury or surgery of the lower extremity
- having systemic and metabolic disease
- having behavioral and cognitive problems that prevent consistence to guidelines given
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 |
|---|---|---|
| Standard physiotherapy program+50 Hz local vibrationStandard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (50 Hz) for 10 minutes will be performed 3 days a week for 8 weeks. | Other | Treatment Group 50 Hz |
| Standard physiotherapy program+100 Hz local vibrationStandard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (100 Hz) for 10 minutes will be performed 3 days a week for 8 weeks. | Other | Treatment Group 100 Hz |
| Standard physiotherapy programStandard physiotherapy program (strength, balance, gait exercises) for 60 minutes will be performed 3 days a week for 8 weeks. | Other | Control Group |
Primary outcome
Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography
Time frame: 3 minutes
Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Muscle Thickness and Fascicle Length would be expressed as centimeters.
Evaluation of Pennation Angle with Ultrasonography
Time frame: 2 minutes
Bilateral Medial Gastrocnemius US evaluations were performed with use of a 5-10 MHz linear probe (Diasus Dynamic Imaging Ltd, Livingston, Scotland,UK). Patients were positioned prone position with their legs and their muscles relaxed for medial gastrocnemius. Pennation Angle would be angularly indicated.
6 secondary outcomes
Assessment of spasticity
Time frame: 5 minutes
Assessment of viscoelastic properties of muscle
Time frame: 5 minutes
Assessment of ankle proprioception
Time frame: 5 minutes
Assessment of single leg balance
Time frame: 3 minutes
Assessment of balance
Time frame: 10 minutes
Assessment of gait characterictics
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Derived from this study: PubMed 33836458Ayvat F, Ozcakar L, Ayvat E, Aksu Yildirim S, Kilinc M. Effects of low vs. high frequency local vibration on mild-moderate muscle spasticity: Ultrasonographical and functional evaluation in patients with multiple sclerosis. Mult Scler Relat Disord. 2021 Jun;51:102930. doi: 10.1016/j.msard.2021.102930. Epub 2021 Mar 31.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physiotherapy program+50 Hz local vibration, Standard physiotherapy program+100 Hz local vibration and Standard physiotherapy program in people with Multiple Sclerosis, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Ayvat, MSc (+905514252059, fatma.avcu@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Muscle Thickness and Fascicle Length with Ultrasonography (time frame: 3 minutes). 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?
On the ClinicalTrials.gov record for NCT04192786, 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 30 Jun 2020.