Effects of Exercises in MS on Postural Control With Dual Task (MScombined)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, pilates, aquatherapy, postural control, dual task
Eligibility Criteria
Inclusion Criteria:
- being over 18 years old
- ability to walk independently or with single walking aid
- having stable symptoms
Exclusion Criteria:
- being acute or unstable phase of disease
- having EDSS score>6
- insuitable for the pool (incontinance, dermatological disease etc.)
Sites / Locations
- Dokuz Eylül University, School of Physical Therapy and RehabilitationRecruiting
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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
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
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.
Full Information
NCT ID
NCT03718819
First Posted
October 16, 2018
Last Updated
October 25, 2018
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT03718819
Brief Title
Effects of Exercises in MS on Postural Control With Dual Task
Acronym
MScombined
Official Title
Effects of Combined Exercises on Postural Control With and Without Dual Task in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, pilates, aquatherapy, postural control, dual task
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Pilates and aquaplyometric exercises will be done combinedly.
Primary Outcome Measure Information:
Title
Change in limits of stability parameter with Biodex Balance System
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 limits of stability parameter with cognitive task by Biodex Balance System
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
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
Title
Change in timed up and go test
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in 5-Repetititon Sit-To-Stand Test
Description
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
Time Frame
Baseline and 8 weeks
Title
Change in timed 25 step walking test
Description
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
Time Frame
Baseline and 8 weeks
Title
Handgrip strength test
Description
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.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being over 18 years old
ability to walk independently or with single walking aid
having stable symptoms
Exclusion Criteria:
being acute or unstable phase of disease
having EDSS score>6
insuitable for the pool (incontinance, dermatological disease etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melda Soysal Tomruk, PhD
Phone
+905376053045
Email
melda.soysal@deu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barış Gürpınar, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylül University, School of Physical Therapy and Rehabilitation
City
İzmir
State/Province
Balçova
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melda Soysal Tomruk
Phone
5376053045
Email
melda.soysal@deu.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
via clinical study
IPD Sharing Time Frame
in 2 years
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Effects of Exercises in MS on Postural Control With Dual Task
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