Climate Influence on Physiotherapy in Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 6-minute walk test
Study Overview
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.
Detailed Description
Empirically, several patients with MS have reported improved function in warm climate during therapy or vacation. This is in contrast to the heat intolerance frequently reported in MS. Heat intolerance seems, however, to be individually distributed among the MS patients, and may seem to be related to the degree of warmth.
Sixty patients with gait problems and without heat intolerance were included in a cross-over study. They were randomized to a 4-week inpatient physiotherapy based on the Bobath concept in Norway or Spain, with cross-over the year after. Data from five physical performance measures and six self-reported measures were collected at screening, baseline, after treatment and three and six months after both treatment-periods. Change over time within groups and comparisons of change between groups were analyzed by mixed models.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •An active MS (attack or progression) during one month prior to inclusion or start of treatment.
- •Received treatment with glucocorticoids the last month prior to inclusion or start of treatment.
- •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
Outcomes
Primary Outcomes
6-minute walk test
Time Frame: 2 years
Secondary Outcomes
- 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)
- Multiple Sclerosis Impact Scale (MSIS-29)(2)
- Fatigue Severity Scale(2)
- Numerical Rating Scale; gait, balance, pain(2)
- Modified Health Assessment Questionnaire(2)
- Patient Global Impression of Change(2)