Multiple SclerosisMScombinedNCT03718819
Effects of Exercises in MS on Postural Control With Dual Task
A study testing exercise in people with Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis is a progressive neurological disease that associated with demyelinization and axonal damage. Decreased postural control is one of the initial symptom of disease. Improving postural control in people with neurological impairment is a common goal of physiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- exercise
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 30 Nov 2018
- 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
- being over 18 years old
- ability to walk independently or with single walking aid
- having stable symptoms
Who cannot join
- being acute or unstable phase of disease
- having EDSS score>6
- insuitable for the pool (incontinance, dermatological disease etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylül University, School of Physical Therapy and Rehabilitation
Izmir, Balçova, 35330
Melda Soysal Tomruk, 5376053045, melda.soysal@deu.edu.tr
About this study
Official title: Effects of Combined Exercises on Postural Control With and Without Dual Task in Patients With Multiple Sclerosis
Multiple sclerosis is a progressive neurological disease that associated with demyelinization and axonal damage. Decreased postural control is one of the initial symptom of disease. Improving postural control in people with neurological impairment is a common goal of physiotherapy. Doing exercises in water or land are examples for effective solutions. Pilates and aquaplyometric exercises are some of these approaches.
Performing daily activities at the same time requires dual tasking or multi tasking. Dual tasking is frequently impaired in MS. The aim of the study was to determine effect of combined Pilates and Aquaplyometric exercises on postural control with or without dual task in patients with multiple sclerosis.
Read the detailed description
MS patients with decreased postural control will be enrolled eight-week, 45 minutes combined Pilates and aquaplyometric exercise programme. Postural control, hand dexterity and other functional parameteres will assess besaline and at the eighth week of exercise programme by the physiotherapist. Postural control will evaluate with and without dual task.
- Conditions
- Multiple Sclerosis
- Being tested
- exercise
- Keywords
- multiple sclerosis, pilates, aquatherapy, postural control, dual task
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Pilates and aquaplyometric exercises will be done combinedly.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in limits of stability parameter with Biodex Balance System
measured with Biodex Balance System (BBS; SD 12.1"Display 115 VAC). Patients were asked to stand on the rigid surface with barefoot and eyes open during measuring limits of stability. During each test trial, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of the nine targets. Targets on the screen blink in random order. The tests repeated three times with 30 second resting time between trials. Patients' performance is evaluated from a total score of 100 where the higher score represents better trunk control.
Measured: Baseline and 8 weeks
Change in limits of stability parameter with cognitive task by Biodex Balance System
Patients are asked to perform previously explained test protocol while maintaining balance they need to count down three-by-three from a randomly selected two-digit number. . Patients' performance is evaluated from a total score of 100 where the higher score represents better trunk control.
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Change in Nine hole peg Test
The patient is seated at a table with a plastic NHPT placed at the patient's middle and asked to place pegs in a random order as quick as possible by using dominant hand first total time was recorded in seconds. Three consecutive trials with the dominant hand are immediately followed by three consecutive trials with the non-dominant hand.
Measured: Baseline and 8 weeks
Change in timed up and go test
test was used to assess mobility and static and dynamic balance. The starting point was determined after the patient had been seated in a standart height chair with their back flush against the chair and their arms resting on the arm rests. The patients asked to stand up, walk three meters, turn around, walk back to the chair and sit down again. During the test the patients was expected to wear their regular footwear and use any mobility aids that they would normally require. Timing began when the patient started to rise and ended when returned to the chair and sit down. Lower time score represents better mobility and balance.
Measured: Baseline and 8 weeks
Change in 5-Repetititon Sit-To-Stand Test
test is a meaure of the time taken to complete five repetitions of the STS movement. The patients were told to start the test in a seated position with full weight on the chair and arms folded across the chest. The feet were placed parallel to each other. The patients asked to move to a standing position with full knee extention and then back to a seated position as quickly as possible. After completion of five repetitions the test ended when patient touched the seat. Lower time score represents better lower extremity muscle strength
Measured: Baseline and 8 weeks
Change in timed 25 step walking test
The patients were directed to one end of a clearly marked 25-foot course and was instructed to walk 25 feet as quickly as possible but safely. The time was calculated from the initiation of the instruction to start and ended when the patient had reached the 25-foot mark. Lower time score represents better walking or mobility performance
Measured: Baseline and 8 weeks
Handgrip strength test
The patient was seated at a table and the subject holded the dynamometer in the dominant hand with the arm at right angles (90˚ flexion) and the elbow by the side of the body. The handle of the dynamometer was adjusted as the base should rest on first metacarpal, while the handle should rest on middle of four fingers. When ready the patient asked to squeeze the dynamometer with maximum isometric effort, which was maintained for about 5 seconds. Three consecutive trials were done and higher score was recorded (25). Higher score represents better grip force.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Mar 2018
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melda Soysal Tomruk, Dokuz Eylul University
- Investigators
- Barış Gürpınar, PhD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718819
- Sponsor's protocol ID
- MST0047
- Acronym
- MScombined
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: via clinical study
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Exercises on Postural Control With and Without Dual Task in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03718819
- Acronym / sponsor ID
- MScombined / MST0047
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, pilates, aquatherapy, postural control, dual task
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 24 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.
Multiple sclerosis is a progressive neurological disease that associated with demyelinization and axonal damage. Decreased postural control is one of the initial symptom of disease. Improving postural control in people with neurological impairment is a common goal of physiotherapy. Doing exercises in water or land are examples for effective solutions. Pilates and aquaplyometric exercises are some of these approaches.
Performing daily activities at the same time requires dual tasking or multi tasking. Dual tasking is frequently impaired in MS. The aim of the study was to determine effect of combined Pilates and Aquaplyometric exercises on postural control with or without dual task in patients with multiple sclerosis.
Detailed description
MS patients with decreased postural control will be enrolled eight-week, 45 minutes combined Pilates and aquaplyometric exercise programme. Postural control, hand dexterity and other functional parameteres will assess besaline and at the eighth week of exercise programme by the physiotherapist. Postural control will evaluate with and without dual task.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being over 18 years old
- ability to walk independently or with single walking aid
- having stable symptoms
Key exclusion criteria (3 listed)
- being acute or unstable phase of disease
- having EDSS score>6
- insuitable for the pool (incontinance, dermatological disease etc.)
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 |
|---|---|---|
| exercisePilates and aquaplyometric exercises will be done combinedly. | Other | – |
Primary outcome
Change in limits of stability parameter with Biodex Balance System
Time frame: Baseline and 8 weeks
measured with Biodex Balance System (BBS; SD 12.1"Display 115 VAC). Patients were asked to stand on the rigid surface with barefoot and eyes open during measuring limits of stability. During each test trial, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of the nine targets. Targets on the screen blink in random order. The tests repeated three times with 30 second resting time between trials. Patients' performance is evaluated from a total score of 100 where the higher score represents better trunk control.
Change in limits of stability parameter with cognitive task by Biodex Balance System
Time frame: Baseline and 8 weeks
Patients are asked to perform previously explained test protocol while maintaining balance they need to count down three-by-three from a randomly selected two-digit number. . Patients' performance is evaluated from a total score of 100 where the higher score represents better trunk control.
5 secondary outcomes
Change in Nine hole peg Test
Time frame: Baseline and 8 weeks
Change in timed up and go test
Time frame: Baseline and 8 weeks
Change in 5-Repetititon Sit-To-Stand Test
Time frame: Baseline and 8 weeks
Change in timed 25 step walking test
Time frame: Baseline and 8 weeks
Handgrip strength test
Time frame: Baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: Yes. via clinical study
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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.
Barış Gürpınar, PhD principal investigator
Dokuz Eylul 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 exercise in people with Multiple Sclerosis, run by Dokuz Eylul 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 29 Oct 2018. 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 Melda Soysal Tomruk, PhD (+905376053045, melda.soysal@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in limits of stability parameter with Biodex Balance System (time frame: Baseline and 8 weeks). 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 29 Oct 2018.