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Treatment Of chronic Fatigue in patients with multiple sclerosis by paramedical disciplines

Effects of multidisciplinary paramedic rehabilitation on chronic fatigue in multiple sclerosis: A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05017507
Enrollment
48
Registered
2013-08-05
Start date
2006-02-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Multiple sclerosis, fatigue Nervous System Diseases Multiple sclerosis

Interventions

Multidisciplinary paramedical rehabilitation. Patients assigned to multidisciplinary rehabilitation receive either occupational therapy, physical therapy or social work or any combination of these tr

Sponsors

Stichting MS Research (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age > 18 years, either sex 2. Diagnosed with MS according to the criteria of McDonald [Mc Donald 2001] and 3. Suffering from chronic fatigue. Chronic fatigue was defined as ?being present for any amount of time on at least 50 percent of the days, for more than 6 weeks? as agreed on by the Multiple Sclerosis Council for Clinical Practice Guidelines.

Exclusion criteria

Exclusion criteria: Patients were excluded in case of: 1. Current MS relapse 2. Pregnancy 3. Current inflammation (cystitis) 4. Alcohol or substance abuse 5. Physical conditions like muscle spasm or pain, or 6. Depressive symptomatology importantly contributing to fatigue

Design outcomes

Primary

MeasureTime frame
Fatigue assessed using the self report questionnaire Checklist individual strength (CIS-20R): 20 statements for which the participant has to indicate on a 7 point scale ranging from ?Yes, that is true? to ?No, that is not true? to what extent the particular statement applies to him or her, at baseline, 12 weeks and 24 weeks.

Secondary

MeasureTime frame
1. Modified Fatigue Impact Scale (MFIS): assesses the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning during the past 4 weeks. Participants rate on a 5-point Likert scale, ranging from ?Never? to ?Almost always?, their agreement with 21 statements. 2. Fatigue Severity Scale (FSS): a nine-item questionnaire to assess the severity of fatigue and its impact on an individual?s daily functioning using a seven-point rating scale. Participants rate their agreement with a statement ranging from one point, reflecting ?strongly disagree? to seven points representing ?strongly agree?, depending on how appropriate they feel the statement applies to them 3. Functional Independence Measure (FIM): measures activities of daily living. It is an 18-item, generic seven-point rating scale to assess physical and cognitive disability in terms of burden of care. 4. Disability and Impact Profile (DIP): is a 39 item self-administered questionnaire regarding activities that may be restricted by a disabling disease. Each item is rated on a 0-10 point scale for its current disability and for the importance of that disability 5. Multiple Sclerosis Impact Scale (MSIS-29): disease-specific measure of the physical (20 items) and psychological (9 items) impact of MS from the patient?s perspective. The self-reported instrument measures disease impact due to limitations in the past 2 weeks, scored on 5 levels from ??not at all?? to ??extremely.?? Scores on the individual items are added and then transformed to a 0?100 scale, thereby generating two summary scores (for physical and psychological impact). 6. Impact on Participation and Autonomy (IPA): measures person-perceived participation. The IPA is a generic questionnaire that addresses 2 different aspects of participation: (1) perceived participation, reflected in 31 items in 5 domains (interior and exterior autonomy, family role, social relations and job and education) , and (2) the experience of p

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026