Effects of highly specialized rehabilitation of patients with multiple sclerosis

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN05245917
• Lead Sponsor: The Danish Sclerosis Hospitals (Denmark)

Brief Summary

2012 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/22954027 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31687884/ (added 27/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-06
• Study Completion: 2013-06-30
• Last Update Posted: 11 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Study participants will be recruited among all patients who are referred to the 4-week individual rehabilitation program during March 2012 to June 2013. Patients who are referred for a shorter rehabilitation program or theme courses are not eligible for the study.

Participants must meet the following inclusion criteria:
1. Aged between 18 and 65 years
2. Diagnosis of multiple sclerosis (MS): relapsing remitting, primary or secondary progressive MS
3. Expanded Disability Status Scale (EDSS) score = 7.5
4. Can use a PC or have support/relative who can
5. Ability to read and understand sufficient Danish to understand instructions both orally and in writing, and having completed a consent form

Exclusion Criteria

1. MS disease duration less than 6 months (the period from diagnosis to referral)
2. Experienced relapse within 3 months before the neurological appraisal
3. Recipient of sclerosis-specific hospital-based rehabilitation within the last 6 months
4. Cognition score, Kurtzke's Functional Systems (KFS) > 2 or cognitive limitations which hinder completion of self-reported questionnaires and/or giving informed consent
5. Moderate to severe depression; severe heart or lung disease
6. Drug or alcohol abuse
7. Any other illness that can impede participation in the study

If participants develop a disease that might impair their participation in the study they will be excluded from the study at that time.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Multiple Sclerosis Impact Scale version 2 (MSIS-29) and Functional Assessment of Multiple Sclerosis (FAMS) measured at baseline, at the start of the intervention, at intervention completion, 1, 6 and 12 months after baseline.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mastery: Health Education Impact Questionnaire (heiQ)<br> 2. Generic Quality of Life: EQ-5D and 15D<br> 3. Expanded Disability Status Scale score (EDSS)<br> 4. Resource consumption and costs for hospitals sclerosis for patients and their relatives, and for the rest of the healthcare service<br><br> Measured at baseline, at the start of the intervention, at intervention completion, 1, 6 and 12 months after baseline.<br>