Group-based multidisciplinary rehabilitation for outpatient clients with multiple sclerosis

ISRCTN ISRCTN72556817
DOI https://doi.org/10.1186/ISRCTN72556817
Secondary identifying numbers Social Insurance Institution of Finland reports nro 131
Submission date
06/10/2017
Registration date
20/10/2017
Last edited
19/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Maarit Karhula
Public

Mäntyharju
Mäntyharju
52700
Finland

Study information

Study designMixed methods study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleGroup-based multidisciplinary rehabilitation for outpatient clients with multiple sclerosis improving participation, occupational performance and goal attainment
Study objectivesGroup-based multidisciplinary rehabilitation for outpatient clients with multiple sclerosis improves participation, occupational performance and goal attainment.
Ethics approval(s)1. The Ethics Committees of the Finnish Social Insurance Institution, 02/09/2010
2. The Hospital District of Southwest Finland, ref: 45/180/2012
Health condition(s) or problem(s) studiedMultiple sclerosis
InterventionGroup-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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/02/2010
Completion date31/05/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsAltogether 194 persons, for rehabilitation study 105 persons and in addition 89 persons for the evaluation of the IPA measure
Key inclusion criteria1. 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
Key exclusion criteriaParticipants were excluded if they were not capable of expressing their own choices or answering questions in the questionnaires
Date of first enrolment01/05/2010
Date of final enrolment30/09/2013

Locations

Countries of recruitment

  • Finland

Study participating centre

The Social Insurance Institution of Finland
Helsinki
00056
Finland

Sponsor information

The Social Insurance Institution of Finland
Other

PL 450
Helsinki
00056
Finland

ROR logo "ROR" https://ror.org/057yw0190

Funders

Funder type

Other

The Social Insurance Institution of Finland

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planThe 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2013 Yes No
Results article results 01/03/2014 Yes No
Results article results 01/11/2017 Yes No