Climate Influence on Physiotherapy in Multiple Sclerosis
CIOPIMS
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of the study was to compare the effect of inpatient physiotherapy in a warm climate versus physiotherapy in a colder climate in multiple sclerosis (MS), in both short- and long term perspectives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedJanuary 27, 2010
January 1, 2010
1.9 years
January 26, 2010
January 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-minute walk test
2 years
Secondary Outcomes (10)
Timed Up&Go
2 years
10-metre timed walk
2
Berg Balance Scale
2
Trunk Impairment Scale
2
Borg's Rating of Perceived Exertion
2
- +5 more secondary outcomes
Study Arms (2)
Physiotherapy in Spain
EXPERIMENTALDaily inpatient physiotherapy for four weeks in a warm climate
Physiotherapy in Norway
EXPERIMENTALDaily inpatient physiotherapy for four weeks in a cold climate
Interventions
Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks
Eligibility Criteria
You may qualify if:
- Between 18 and 60 years of age (both included).
- Multiple sclerosis according to the McDonald criteria
- Disability equivalent to Expanded Disability Status Score (EDSS) between 4.0 and 6.5 (both included)
- Prepared to and considered able to follow the protocol and to attend the planned visits during the whole study period.
- Given written informed consent
You may not qualify if:
- Excessive fatigue or severe cognitive dysfunction related to MS that would preclude safe participation in the protocol.
- Suffered from major depression or any other psychiatric disorder that would preclude safe participation in the protocol.
- Heat intolerance.
- Other serious concomitant disease that could preclude safe participation in the protocol.
- Alcohol or drug abuse or consumption that could preclude participation according to the protocol and to attend the planned visits during the whole study period.
- Breastfeeding or pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haukeland University Hospitallead
- Oslo University Hospitalcollaborator
- University Hospital, Akershuscollaborator
- University of Bergencollaborator
Study Sites (1)
Haukeland University Hospital
Bergen, 5021, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tori Smedal, MSc
Haukeland University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
June 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
January 27, 2010
Record last verified: 2010-01