Multiple Sclerosis Rehabilitation Study

Multiple Sclerosis Clinical Trial

Official title:

'Functioning and Disability' and 'Quality of Life' in an Australian Community Cohort With Multiple Sclerosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202254
• Other study ID #: HREC 2004.101
• Secondary ID: MelbUni HREC 040
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: June 1, 2015
• Start date: December 2004
• Est. completion date: December 2005

Study information

• Verified date: June 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The effects of routine rehabilitation in MS patients versus no rehabilitation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Physiotherapy

• Occupational therapy

• Speech pathology

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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.