Climate Influence on Physiotherapy in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CIOPIMS  

Official title:

Climate Influence on Physiotherapy in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057719
• Other study ID #: 012.06
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: January 26, 2010
• Start date: June 2006
• Est. completion date: May 2008

Study information

• Verified date: January 2010
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Directorate of HealthNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (4)

Lead Sponsor	Collaborator
Haukeland University Hospital	Oslo University Hospital, University Hospital, Akershus, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test		2 years	No
Secondary	Timed Up&Go		2 years	No
Secondary	10-metre timed walk		2	No
Secondary	Berg Balance Scale		2	No
Secondary	Trunk Impairment Scale		2	No
Secondary	Borg's Rating of Perceived Exertion		2	No
Secondary	Multiple Sclerosis Impact Scale (MSIS-29)		2	No
Secondary	Fatigue Severity Scale		2	No
Secondary	Numerical Rating Scale; gait, balance, pain		2	No
Secondary	Modified Health Assessment Questionnaire		2	No
Secondary	Patient Global Impression of Change		2	No