Plain English Summary
Background and study aims
Multiple sclerosis (MS) is a condition that affects the brain and/or spinal cord, causing problems with vision, arm or leg movement, sensation or balance. A two-year multi-professional group-based out-patient rehabilitation program has been developed for people with MS based on themes of energy conservation, cognition, mood and body control. The aim of this study is to test the effect of this rehabilitation model on the participation and daily life of people with MS. The study also tests the Impact on Participation and Autonomy (IPA) measure, which was translated into Finnish during the study, and aims to find out which factors are associated with participation and autonomy of people with MS.
Who can participate?
People with MS aged between 18 and 65
What does the study involve?
Participants take part in group-based rehabilitation every two weeks. The sessions last 3-6 hours. Carers of the participants are involved in the part of the sessions. A comparison group of 19 people with MS receive typical rehabilitation for people with severe disabilities which contains mainly physiotherapy. In addition to test the IPA questionnaire more data is collected from people with MS during an in-patient rehabilitation period of 1-3 weeks at Masku Neurological Rehabilitation Center. The rehabilitation model is evaluated with questionnaires for rehabilitees, their families, service providers and co-operation partners on four occasions and with focus-group interviews with the rehabilitees. Rehabilitees’ participation restrictions, occupational performance and rehabilitation goal attainment are measured.
What are the possible benefits and risks of participating?
Participants may benefit from the group-based rehabilitation by improving their participation in everyday life and also become more conscious about their perceived participation in everyday life. The study carries low or no risk of harm to the participants.
Where is the study run from?
The Social Insurance Institution of Finland
When is the study starting and how long is it expected to run for?
August 2010 to September 2013
Who is funding the study?
The Social Insurance Institution of Finland
Who is the main contact?
Maarit Karhula
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Social Insurance Institution of Finland reports nro 131
Study information
Scientific title
Group-based multidisciplinary rehabilitation for outpatient clients with multiple sclerosis improving participation, occupational performance and goal attainment
Acronym
Study hypothesis
Group-based multidisciplinary rehabilitation for outpatient clients with multiple sclerosis improves participation, occupational performance and goal attainment.
Ethics approval
1. The Ethics Committees of the Finnish Social Insurance Institution, 02/09/2010
2. The Hospital District of Southwest Finland, ref: 45/180/2012
Study design
Mixed methods study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Multiple sclerosis
Intervention
Group-based multidisciplinary rehabilitation targeting to energy saving, cognition, mood and body control.
The multicentre, cross-sectional study involved 80 participants, of whom 38 persons participated in rehabilitation based on medical rehabilitation services for persons with severe disabilities and 42 based on discretionary rehabilitation services for people with disabilities. In addition 6 persons participated in the rehabilitation but not in the post measures. A comparison group of 19 persons with MS received typical rehabilitation based on medical rehabilitation services for persons with severe disabilities. Total duration of treatment was 21 months.
In addition to evaluate the psychometric properties of the IPA and factors that predict participation and autonomy of persons with MS additional data was collected from persons (n=89) with MS in 2012–2013 during an in-patient rehabilitation period of 1-3 weeks at Masku Neurological Rehabilitation Center in order to receive a larger sample.
The functionality of the rehabilitation model was evaluated with questionnaires for rehabilitees, their families, service providers and co-operation partners on four occasions during the rehabilitation project and with focus-group interviews with the rehabilitees. Primary outcome measures were rehabilitees’ participation restrictions, occupational performance and rehabilitation goal attainment.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Autonomy and participation, measured using the Impact on Participation and Autonomy measure
2. Self-perceived problems in everyday activities and participation, measured using Canadian Occupational Performance Measure
3. Goal attainment during rehabilitation, measured using Goal Attainment Scaling
Measured at baseline, 12 months and 21 months
Secondary outcome measures
1. Quality of life, measured using WHOQOL-BREF
2. Perceived impact of disease, measured using Multiple Sclerosis Impact Scale
Measured at baseline, 12 months and 21 months
Overall trial start date
01/02/2010
Overall trial end date
31/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 65 years (inclusive)
2. A confirmed diagnosis of MS
3. Ability to fill in questionnaires independently or with the help of an assistant
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Altogether 194 persons, for rehabilitation study 105 persons and in addition 89 persons for the evaluation of the IPA measure
Participant exclusion criteria
Participants were excluded if they were not capable of expressing their own choices or answering questions in the questionnaires
Recruitment start date
01/05/2010
Recruitment end date
30/09/2013
Locations
Countries of recruitment
Finland
Trial participating centre
The Social Insurance Institution of Finland
Helsinki
00056
Finland
Funders
Funder type
Other
Funder name
The Social Insurance Institution of Finland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The report of the project is available: https://helda.helsinki.fi/handle/10138/42945
Other publications are planned to published in high-impact peer reviewed journals during 2018 and 2019
IPD sharing statement
The data consisting of filled measure forms and informed consent of participants were stored in the archive of Social Insurance Institution of Finland. The data will be stored for 10 years after data collection.
Intention to publish date
31/12/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/22816381
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24506664
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28049364