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Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined exercise training
Task-oriented training
Sponsored by
Bezmialem Vakif 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 task-oriented training, exercise training, mobility, balance, fatigue, quality of life

Eligibility Criteria

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

Inclusion Criteria:

  • Multiple Sclerosis diagnosis
  • Expanded Disability Status Scale > 5,5
  • No cognitive problems
  • No relapses in the last 3 months
  • No other neurological or chronic disease

Exclusion Criteria:

  • Relapse during the intervention
  • Exercise intolerance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Training group

    Arm Description

    Patients in this group will receive combined exercise training included aerobic and strengthening exercises, 3 times a week for 6 weeks. All exercise sessions will be performed under the supervision of a physiotherapist.

    Patients in this group will receive task-oriented training additional to combined exercise training 3 times a week for 6 weeks. Task-oriented training included more functional daily life mobility activities like reaching, obstacle walking, stairs climbing. All exercise sessions will be performed under the supervision of a physiotherapist.

    Outcomes

    Primary Outcome Measures

    Functional capacity
    Change from baseline functional capacity with six minute walking test

    Secondary Outcome Measures

    dynamic gait skills
    Change from baseline functional mobility with dynamic gait index
    limitation of gait
    Change from baseline functional mobility with MS walking scale-12
    dynamic balance and fall risk
    Change from baseline functional mobility with timed up and go test
    sitatic balance
    Change from baseline balance with functional reach test
    dynamic balance
    Change from baseline balance with berg balance scale
    severity of fatigue
    Change from baseline fatigue with fatigue severity scale
    impact of fatigue
    Change from baseline fatigue with fatigue impact scale
    Quality of life
    Change from baseline quality of life with MS quality of life instrument-54

    Full Information

    First Posted
    April 3, 2018
    Last Updated
    April 12, 2018
    Sponsor
    Bezmialem Vakif University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03497468
    Brief Title
    Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
    Official Title
    Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2018 (Anticipated)
    Primary Completion Date
    June 1, 2018 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bezmialem Vakif 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 (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life. The importance of exercise training in disease management has been emphasized in recent years. However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease. The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis, Relapsing-Remitting
    Keywords
    task-oriented training, exercise training, mobility, balance, fatigue, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group will receive combined exercise training included aerobic and strengthening exercises, 3 times a week for 6 weeks. All exercise sessions will be performed under the supervision of a physiotherapist.
    Arm Title
    Training group
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive task-oriented training additional to combined exercise training 3 times a week for 6 weeks. Task-oriented training included more functional daily life mobility activities like reaching, obstacle walking, stairs climbing. All exercise sessions will be performed under the supervision of a physiotherapist.
    Intervention Type
    Other
    Intervention Name(s)
    Combined exercise training
    Intervention Description
    Aerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities
    Intervention Type
    Other
    Intervention Name(s)
    Task-oriented training
    Intervention Description
    Functional reaching, walking on different obstacles and floor,sitting and standing on different levels and surface,walking around obstacle, climbing stairs with different height and surface
    Primary Outcome Measure Information:
    Title
    Functional capacity
    Description
    Change from baseline functional capacity with six minute walking test
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    dynamic gait skills
    Description
    Change from baseline functional mobility with dynamic gait index
    Time Frame
    6 weeks
    Title
    limitation of gait
    Description
    Change from baseline functional mobility with MS walking scale-12
    Time Frame
    6 weeks
    Title
    dynamic balance and fall risk
    Description
    Change from baseline functional mobility with timed up and go test
    Time Frame
    6 weeks
    Title
    sitatic balance
    Description
    Change from baseline balance with functional reach test
    Time Frame
    6 weeks
    Title
    dynamic balance
    Description
    Change from baseline balance with berg balance scale
    Time Frame
    6 weeks
    Title
    severity of fatigue
    Description
    Change from baseline fatigue with fatigue severity scale
    Time Frame
    6 weeks
    Title
    impact of fatigue
    Description
    Change from baseline fatigue with fatigue impact scale
    Time Frame
    6 weeks
    Title
    Quality of life
    Description
    Change from baseline quality of life with MS quality of life instrument-54
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Multiple Sclerosis diagnosis Expanded Disability Status Scale > 5,5 No cognitive problems No relapses in the last 3 months No other neurological or chronic disease Exclusion Criteria: Relapse during the intervention Exercise intolerance
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kamer Unal-Eren, PT, PhD
    Phone
    +902125232288
    Ext
    4650
    Email
    kamerunals@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis

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