Multiple SclerosisNCT00202254
Multiple Sclerosis Rehabilitation Study
A study testing Physiotherapy, Occupational therapy and Speech pathology in people with Multiple Sclerosis, run by Melbourne Health.
Trial summary
The effects of routine rehabilitation in MS patients versus no rehabilitation. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physiotherapy, Occupational therapy and Speech pathology
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS>2.-
About this study
Official title: '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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Physiotherapy, Occupational therapy, Speech pathology
- Keywords
- Mulitple Sclerosis, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
Occupational therapyBehavioural
Speech pathologyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
- 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Investigators
- Fary Khan, Principal investigator, Melbourne Extended Care Rehabilitation Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202254
- Sponsor's protocol ID
- HREC 2004.101
- Other IDs
- MelbUni HREC 040334
- Status last verified
- Jun 2015
- First submitted
- 12 Sep 2005
- Last updated
- 3 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Functioning and Disability' and 'Quality of Life' in an Australian Community Cohort With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT00202254
- Acronym / sponsor ID
- HREC 2004.101
- Conditions
- Multiple Sclerosis
- Keywords
- Mulitple Sclerosis, MS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS>2.-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy | Behavioural | – |
| Occupational therapy | Behavioural | – |
| Speech pathology | Behavioural | – |
Primary outcome
Improvement in fatigue levels and psychological well being (depression, stress and anxiety) in MS patients. Outcome will be measured at 13 months since recruitment.
1 secondary outcome
- 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fary Khan principal investigator
Melbourne Extended Care Rehabilitation Service
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy, Occupational therapy and Speech pathology in people with Multiple Sclerosis, run by Melbourne Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in fatigue levels and psychological well being (depression, stress and anxiety) in MS patients. Outcome will be measured at 13 months since recruitment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.