Multiple Sclerosis, Relapsing-RemittingNCT03679806
Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis
A study testing Halliwick and Aquatic Plyometric Exercises in people with Multiple Sclerosis, Relapsing-Remitting, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare and contrast the effects of two different aquatic exercises on postural control and hand functions in people with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Halliwick and Aquatic Plyometric Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2016to Sep 2016
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EDSS>6
- volunteered
Who cannot join
- Clinical relapse within three months
- incontinence
- persistent infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University School of Physical Therapy and Rehabilitation
Izmir, 35330
About this study
Official title: Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis: Halliwick Versus Aquatic Plyometric Exercises
This study aims to compare and contrast the effects of two different aquatic exercises on postural control and hand functions in people with multiple sclerosis.
Read the detailed description
Impaired limits of stability causes falls in people with Multiple sclerosis (pwMS) whereas a well-controlled posture provides improved upper limb functions which are limited in almost 75% of pwMS due to weakness, spasticity or tremor. It is an already known fact that hand dexterity is an indicator of fall risk due to neuromuscular causes and/or abnormalities in the corpus callosum in pwMS.
Aquatic therapy (AT) provides a safe and effective environment for many therapeutic purposes. It is important to understand the effects of each type, intensity, and duration of the aquatic interventions to accomplish most suitable aquatic exercise program.
Halliwick method, neuromotor treatment approach which uses fluid and mechanical properties of water, is based on postural control by mobilizing and controlling body parts through the Ten Point Program.
During Aquatic Plyometric Exercises, proximal part of the body needs to be stabilized to generate a sudden and powerful contraction at the distal part and stabilization of the proximal joints is necessary for maintaining distal movements in a coordinated way.
It is important to understand the effects of each type, intensity, and duration of the aquatic interventions to accomplish most suitable aquatic exercise program. This study aims to compare and contrast the effects of two different aquatic exercises on postural control and hand function.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Halliwick, Aquatic Plyometric Exercises
- Keywords
- aquatic therapy, Limits of stability, Halliwick, aquatic plyometric exercises
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HalliwickOther
The exercise program was progressed by increasing the speed and the range of motion of the movements. Patients were asked not to accelerate the exercise and to focus on their alignment. Mental adjustment, sagittal rotation, transverse rotation, and combined rotation controls, balances in stillness steps of the Halliwick concept were included.
Aquatic Plyometric ExercisesOther
The APE programme was progressed by increasing speed and the range of motion of the movements. Patients were carefully informed not to deform the exercise just to emulate the speed. The three phases of each exercise; eccentric (or loading) phase, the amortization phase, and the concentric (or unloading) phase explained thoroughly at the beginning of every exercise.
| Study group | Role | What they receive |
|---|---|---|
| Halliwick | Experimental | Exercises were performed in a private pool owned by the local MS society twice in a week for 8 weeks. Pool depth was 120 cm 30-31°C Mental adjustment, sagittal rotation, transverse rotation, and combined rotation controls, balances in stillness steps of the Halliwick concept were included. Receives: Other: Halliwick |
| Aquatic Plyometric Exercise | Experimental | Exercises were performed in a private pool owned by the local MS society twice in a week for 8 weeks. Pool depth was 120 cm 30-31°C. The three phases of each exercise; eccentric (or loading) phase, the amortization phase, and the concentric (or unloading) phase included. Receives: Other: Aquatic Plyometric Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in limits of stability
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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study startMay 2016
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış Gürpınar, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679806
- Sponsor's protocol ID
- msdexerity
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis: Halliwick Versus Aquatic Plyometric Exercises
- ClinicalTrials.gov ID
- NCT03679806
- Acronym / sponsor ID
- msdexerity
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- aquatic therapy, Limits of stability, Halliwick, aquatic plyometric exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Sep 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.
This study aims to compare and contrast the effects of two different aquatic exercises on postural control and hand functions in people with multiple sclerosis.
Detailed description
Impaired limits of stability causes falls in people with Multiple sclerosis (pwMS) whereas a well-controlled posture provides improved upper limb functions which are limited in almost 75% of pwMS due to weakness, spasticity or tremor. It is an already known fact that hand dexterity is an indicator of fall risk due to neuromuscular causes and/or abnormalities in the corpus callosum in pwMS.
Aquatic therapy (AT) provides a safe and effective environment for many therapeutic purposes. It is important to understand the effects of each type, intensity, and duration of the aquatic interventions to accomplish most suitable aquatic exercise program.
Halliwick method, neuromotor treatment approach which uses fluid and mechanical properties of water, is based on postural control by mobilizing and controlling body parts through the Ten Point Program.
During Aquatic Plyometric Exercises, proximal part of the body needs to be stabilized to generate a sudden and powerful contraction at the distal part and stabilization of the proximal joints is necessary for maintaining distal movements in a coordinated way.
It is important to understand the effects of each type, intensity, and duration of the aquatic interventions to accomplish most suitable aquatic exercise program. This study aims to compare and contrast the effects of two different aquatic exercises on postural control and hand function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Halliwick | Experimental | Other: HalliwickExercises were performed in a private pool owned by the local MS society twice in a week for 8 weeks. Pool depth was 120 cm 30-31°C Mental adjustment, sagittal rotation, transverse rotation, and combined rotation controls, balances in stillness steps of the Halliwick concept were included. |
| Aquatic Plyometric Exercise | Experimental | Other: Aquatic Plyometric ExercisesExercises were performed in a private pool owned by the local MS society twice in a week for 8 weeks. Pool depth was 120 cm 30-31°C. The three phases of each exercise; eccentric (or loading) phase, the amortization phase, and the concentric (or unloading) phase included. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- EDSS>6
- volunteered
Key exclusion criteria (3 listed)
- Clinical relapse within three months
- incontinence
- persistent infection
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 |
|---|---|---|
| HalliwickThe exercise program was progressed by increasing the speed and the range of motion of the movements. Patients were asked not to accelerate the exercise and to focus on their alignment. Mental adjustment, sagittal rotation, transverse rotation, and combined rotation controls, balances in stillness steps of the Halliwick concept were included. | Other | Halliwick |
| Aquatic Plyometric ExercisesThe APE programme was progressed by increasing speed and the range of motion of the movements. Patients were carefully informed not to deform the exercise just to emulate the speed. The three phases of each exercise; eccentric (or loading) phase, the amortization phase, and the concentric (or unloading) phase explained thoroughly at the beginning of every exercise. | Other | Aquatic Plyometric Exercise |
Primary outcome
Change in limits of stability
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 Nine hole peg Test
Time frame: Baseline and 8 weeks
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.
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 20 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Halliwick and Aquatic Plyometric Exercises in people with Multiple Sclerosis, Relapsing-Remitting, 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 2 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: finished, as of the sponsor's last update on 20 Sep 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?
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 in limits of stability (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 20 Sep 2018.