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Multiple Sclerosis Rehabilitation Study

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapy
Occupational therapy
Speech pathology
Sponsored by
Melbourne Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Mulitple Sclerosis, MS

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups.- Age 19-64 years.- Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2). Exclusion Criteria: Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS>2.-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Improvement in fatigue levels and psychological well being (depression, stress and anxiety) in MS patients. Outcome will be measured at 13 months since recruitment.

    Secondary Outcome Measures

    - Improvement in function and activities of daily living ie. disability- Quality of life.- Carer Burder in multiple sclerosis.- Utilisation of health services.- 13 months follow up.

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    June 1, 2015
    Sponsor
    Melbourne Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00202254
    Brief Title
    Multiple Sclerosis Rehabilitation Study
    Official Title
    'Functioning and Disability' and 'Quality of Life' in an Australian Community Cohort With Multiple Sclerosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Melbourne Health

    4. Oversight

    5. Study Description

    Brief Summary
    The effects of routine rehabilitation in MS patients versus no rehabilitation.
    Detailed Description
    Routine rehabilitation inervention in patients with MS. This comprises of medical and nursing input, physiotherapy, occupational therapy, speech pathology, neuropsychology, compared with a "control" group on the waiting list for rehabilitation intervention. Duration of intervention is 6 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Mulitple Sclerosis, MS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Physiotherapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Occupational therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Speech pathology
    Primary Outcome Measure Information:
    Title
    Improvement in fatigue levels and psychological well being (depression, stress and anxiety) in MS patients. Outcome will be measured at 13 months since recruitment.
    Secondary Outcome Measure Information:
    Title
    - Improvement in function and activities of daily living ie. disability- Quality of life.- Carer Burder in multiple sclerosis.- Utilisation of health services.- 13 months follow up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups.- Age 19-64 years.- Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2). Exclusion Criteria: Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS>2.-
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fary Khan
    Organizational Affiliation
    Melbourne Extended Care Rehabilitation Service
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Multiple Sclerosis Rehabilitation Study

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