Skip to content

Effects of highly specialized rehabilitation of patients with multiple sclerosis

Effects of highly specialized rehabilitation of patients with multiple sclerosis: a randomized controlled trial of personalized, targeted and multidisciplinary interventions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05245917
Enrollment
400
Registered
2012-06-06
Start date
2012-03-01
Completion date
Unknown
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

Patients who fulfil the inclusion criteria and have signed the consent form will be randomised to either the intervention group, which includes early rehabilitation (after less than 2 months from refe

Sponsors

The Danish Sclerosis Hospitals (Denmark)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026