- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679806
Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis
Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis: Halliwick Versus Aquatic Plyometric Exercises
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Izmir, Turkey, 35330
- Dokuz Eylul University School of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- EDSS>6
- volunteered
Exclusion Criteria:
- Clinical relapse within three months
- incontinence
- persistent infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Halliwick
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.
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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.
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Experimental: Aquatic Plyometric Exercise
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in limits of stability
Time Frame: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Change in Nine hole peg Test
Time Frame: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- msdexerity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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