Climate Influence on Physiotherapy in Multiple Sclerosis

NCT ID: NCT01057719

Last Updated: 2010-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-05-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapy in Spain

Daily inpatient physiotherapy for four weeks in a warm climate

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks

Physiotherapy in Norway

Daily inpatient physiotherapy for four weeks in a cold climate

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks

Interventions

Physiotherapy

Individual tailored physiotherapy according to the Bobath concept sixty minutes each working day for four weeks

Intervention Type: OTHER

Other Intervention Names

Physical Therapy; Subtropical climate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Haukeland University Hospital

Principal Investigators

Tori Smedal, MSc

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Other Identifiers

012.06

Identifier Type: -

Identifier Source: org_study_id