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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functioning & Disability and Quality of Life in an Australian Community Cohorts with Multiple Sclerosis
Scientific title
Functional outcomes, disability and quality of life following rehabilitation in patients with multiple sclerosis
Secondary ID [1] 201 0
University of Melbourne HREC: University of Melbourne HREC No. 040334
Secondary ID [2] 202 0
Royal Melbourne Hospital HREC: Royal Melbourne Hospital HREC No. 2004.101
Universal Trial Number (UTN)
Trial acronym
MS Rehabilitation Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 824 0
Condition category
Condition code
Neurological 888 888 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 889 889 0 0
Other physical medicine / rehabilitation

Study type
Description of intervention(s) / exposure
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.
Intervention code [1] 551 0
Comparator / control treatment
Control group

Primary outcome [1] 1151 0
Improvement in fatigue levels in MS patients.
Timepoint [1] 1151 0
Outcome will be measured at 13 months since recruitment.
Primary outcome [2] 1152 0
Improvement in psychological well being including depression in MS patients.
Timepoint [2] 1152 0
Outcome will be measured at 13 months since recruitment.
Primary outcome [3] 1153 0
Improvement in fatigue levels and psychological well being including stress in MS patients.
Timepoint [3] 1153 0
Outcome will be measured at 13 months since recruitment.
Primary outcome [4] 1154 0
Improvement in psychological well being including anxiety in MS patients.
Timepoint [4] 1154 0
Outcome will be measured at 13 months since recruitment.
Secondary outcome [1] 2116 0
Improvement in function and activities of daily living ie. Disability
Timepoint [1] 2116 0
13 months follow up.
Secondary outcome [2] 2117 0
Quality of life
Timepoint [2] 2117 0
13 months follow up.
Secondary outcome [3] 2118 0
Carer Burder in multiple sclerosis
Timepoint [3] 2118 0
13 months follow up.
Secondary outcome [4] 2119 0
Utilisation of health services
Timepoint [4] 2119 0
13 months follow up.

Key inclusion criteria
Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups. - Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2).
Minimum age
19 Years
Maximum age
64 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS>2.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
using opaque envelopes with patient ID numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using a computer statistical software program SPSS
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 981 0
Name [1] 981 0
Royal Melbourne Hospital
Address [1] 981 0
Country [1] 981 0
Funding source category [2] 982 0
Name [2] 982 0
AFRM RACP research fund for 2005
Address [2] 982 0
Country [2] 982 0
Primary sponsor type
Royal Melbourne Hospital
Secondary sponsor category [1] 846 0
Name [1] 846 0
Department of Medicine, University of Melbourne
Address [1] 846 0
Country [1] 846 0

Ethics approval
Ethics application status
Ethics committee name [1] 2290 0
Royal Melbourne Hospital
Ethics committee address [1] 2290 0
Ethics committee country [1] 2290 0
Date submitted for ethics approval [1] 2290 0
Approval date [1] 2290 0
Ethics approval number [1] 2290 0
Ethics committee name [2] 2291 0
University of Melbourne
Ethics committee address [2] 2291 0
Ethics committee country [2] 2291 0
Date submitted for ethics approval [2] 2291 0
Approval date [2] 2291 0
Ethics approval number [2] 2291 0

Brief summary
This project seeks to study the impact of the WHO international classification of functioning and disability looking at contextural factors affecting people with MS. Secondly to provide specific targetted rehabilitation intervention to the identified problem areas reported by the MS cohort and further to measure and quantify the selected functional and social outcomes from rehabilitation intervention.

Specific research questions include:
- establishment of a database to document the prevelence of medical social and functional parameters for a community dwelling cohort of patients with MS.
- to study and compare the effects of disablement on everyday living activities and participation in these persons. This will be done by:
a. record the patient's perceived problems due to MS and their coping ability using an open ended questionnaire.
b. to determine the perspective of their partners/carers regarding problems living with MS.
c. determine the perspective of the treating general practitioner/neurologist regarding problems living with MS.
d. to determine the impact of these listed problems and the distress caused on these patients with measured effects on activities and participation using the WHO ICF classification.
- Determine burden of care for the partner/carer,
- Study the impact of fatigue in persons with MS in the everday activities of daily living and function.
- To measure the impact of defined personal factors such as (depression, anxiety, stress) on the everyday activities and participation.
- Measure the impact of defined environmental factors that affect function and participation in this group.
- Record a generic indicator of health status measure using a general health questionnaire.
- To ascertain self efficacy in this patient group and their carers.
- To provide targetted rehabilitation intervention for these identified problems and measure specific functional and social outcomes.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 36042 0
Address 36042 0
Country 36042 0
Phone 36042 0
Fax 36042 0
Email 36042 0
Contact person for public queries
Name 9740 0
Fary Khan
Address 9740 0
Royal Melbourne Hospital
Royal Park Campus
Administration Building 21
34 - 54 Poplar Road
Parkville VIC 3052
Country 9740 0
Phone 9740 0
+61 3 83872000
Fax 9740 0
+61 3 83872506
Email 9740 0
Contact person for scientific queries
Name 668 0
Fary Khan
Address 668 0
Royal Melbourne Hospital
Royal Park Campus
Administration Building 21
34 - 54 Poplar Road
Parkville VIC 3052
Country 668 0
Phone 668 0
+61 3 83872000
Fax 668 0
+61 3 83872506
Email 668 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary