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Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Halliwick
Aquatic Plyometric Exercises
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring aquatic therapy, Limits of stability, Halliwick, aquatic plyometric exercises

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • EDSS>6
  • volunteered

Exclusion Criteria:

  • Clinical relapse within three months
  • incontinence
  • persistent infection

Sites / Locations

  • Dokuz Eylul University School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Halliwick

Aquatic Plyometric Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
September 19, 2018
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03679806
Brief Title
Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis
Official Title
Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis: Halliwick Versus Aquatic Plyometric Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
aquatic therapy, Limits of stability, Halliwick, aquatic plyometric exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Halliwick
Arm Type
Experimental
Arm Description
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.
Arm Title
Aquatic Plyometric Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Halliwick
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aquatic Plyometric Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in limits of stability
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in Nine hole peg Test
Description
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.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: EDSS>6 volunteered Exclusion Criteria: Clinical relapse within three months incontinence persistent infection
Facility Information:
Facility Name
Dokuz Eylul University School of Physical Therapy and Rehabilitation
City
Izmir
ZIP/Postal Code
35330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects Aquatic Exercises on Balance and Hand Function in Multiple Sclerosis

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