Multiple Sclerosis Rehabilitation Study
June 1, 2015 updated by: Melbourne Health
'Functioning and Disability' and 'Quality of Life' in an Australian Community Cohort With Multiple Sclerosis.
The effects of routine rehabilitation in MS patients versus no rehabilitation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
100
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Improvement in fatigue levels and psychological well being (depression, stress and anxiety) in MS patients. Outcome will be measured at 13 months since recruitment.
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Secondary Outcome Measures
Outcome Measure |
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- 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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fary Khan, Melbourne Extended Care Rehabilitation Service
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
June 3, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC 2004.101
- MelbUni HREC 040334
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.