Contact information
Type
Scientific
Primary contact
Dr Claude Vaney
ORCID ID
Contact details
Berner Klinik Montana
Montana
CH-3963
Switzerland
+41 (0)27 485 53 91
Claude.Vaney@bernerklinik.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Montana07
Study information
Scientific title
Acronym
Montana
Study hypothesis
1. To test the hypothesis that an automated (robotic assisted) locomotor training with the Lokomat in addition to a standard rehabilitation programme is more efficacious than a walking training in addition to a standard rehabilitation in influencing the short and long-term outcome (walking distance in three minutes, health related quality of life, and gait quality) of patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) 3 to 7.0
2. To investigate whether the activity level after the rehabilitation is different in the group with the automated locomotor training compared to the control group
3. To investigate whether the activity level during the inpatient rehabilitation is different compared to the level before the rehabilitation period
4. To investigate whether the immediate, short time influence on gait parameters (symmetry and frequency) are different in the two treatment groups
Ethics approval
Approval received from the Ethic Commission Canton Valais (Switzerland) on the 20th February 2007 (ref: CCVEM 008/07).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Multiple sclerosis
Intervention
All interventions will take place in a rehabilitation setting (three weeks). All interventions during the rehabilitation period (three weeks) are based on scientific evidence, on expert consensus and on patient preferences.
Control (traditional):
Gait-training in group three times a week, maximum of 30 minutes walking, individual physiotherapy including balance related training, three times per week, MOTOmed, hippotherapy, 'neuro'-group in water, sitting group/mat group, no treadmill training.
Intervention (Lokomat):
Automated locomotor training three times a week, maximal of 30 minutes of walking, individual physiotherapy including balance related training, three times per week, MOTOmed, hippotherapy, 'neuro'-group in water, sitting group/mat group, no treadmill training.
Although the rehabilitation is defined 'traditional' rehabilitation it is based on newest evidence and on patient preference. The volume (intensity and frequency) of the interventions are defined by the patients and the medical team.
Intensity of training is defined by the patients its self-evaluation, the patient should work with an intensity of 13 to 17 on the Borg scale (6 to 20) (Borg Dyspnea Scale, which has shown a good mean to monitor and regulate physical exercise). To prevent persistent deterioration of the patient's condition, the level of exertion and well being is evaluated two hours after every training session and intensity will be adapted in the next training sessions if fatigue, exertion and well-being is reduced.
Physiotherapy will be administered and directed in accordance with the ideas, experience and techniques of the personal physiotherapist. This might typically include body awareness training, posture and dynamic control, and non-impact aerobic exercises, accompanied by a range of passive modalities such as massage, stretching, electrotherapy, etc. No attempt will be made to standardise the therapy given by individual therapists, as the treatment is intended to address individual needs of the patients, in all their variety.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Quality of life will be measured at baseline, at discharge (three weeks) and at 3 and 12 months
2. Activity level will be measured during seven days before the rehabilitation, in the middle week of the rehabilitation, and 3 and 12 months after discharge of rehabilitation
3. Gait-parameters (symmetry, gait security, gait speed, gait capacity) will be measured only during rehabilitation setting (at baseline, before and after the third, sixth and ninth gait intervention)
Secondary outcome measures
1. Pain will be measured at baseline, before and after gait interventions (each time), each day in the evening, at three weeks (discharge rehabilitation), 3 and 12 months post rehabilitation
2. Fatique will be measured at baseline, before and after gait interventions (each time), each day in the evening, at three weeks (discharge rehabilitation), 3 and 12 months post rehabilitation
3. Spasticity will be measured at baseline and discharge (at the end of three weeks rehabilitation)
Overall trial start date
10/04/2007
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 or older
2. Diagnosed with multiple sclerosis confirmed by a specialist in neurology by the mean of the McDonald criteria
3. EDSS score equal or higher than 3 and lower or equal than 7.0
4. Able to walk 14 metres (with or without assistive devices)
5. Willingness to comply with any programme to which randomly assigned
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Disorders preventing active rehabilitation (cardiovascular, respiratory, orthopaedic, psychiatric, or other medical conditions, including unhealed decubitus and orthostatic hypotension; pregnancy)
2. Rehabilitation period planned of less than three weeks
3. One or more exacerbations in the preceding three months
4. More than 135 kg
5. Strong asymmetry of musculoskeletal system
6. Length of femur less than 34 cm
Recruitment start date
10/04/2007
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Switzerland
Trial participating centre
Berner Klinik Montana
Montana
CH-3963
Switzerland
Sponsor information
Organisation
Berner Klinik Montana (Switzerland)
Sponsor details
c/o Dr. Claude Vaney
Montana
CH-3963
Switzerland
+41 (0)27 485 53 91
Claude.Vaney@bernerklinik.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Resar University of Applied Sciences in Western Switzerland (Switzerland) (Refs: ReSaR:10/O/06; HES-SO: ReSaR 09-06)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22140197
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23835061
Publication citations
-
Results
Vaney C, Gattlen B, Lugon-Moulin V, Meichtry A, Hausammann R, Foinant D, Anchisi-Bellwald AM, Palaci C, Hilfiker R, Robotic-assisted step training (lokomat) not superior to equal intensity of over-ground rehabilitation in patients with multiple sclerosis., Neurorehabil Neural Repair, 26, 3, 212-221, doi: 10.1177/1545968311425923.
-
Results
Hilfiker R, Vaney C, Gattlen B, Meichtry A, Deriaz O, Lugon-Moulin V, Anchisi-Bellwald AM, Palaci C, Foinant D, Terrier P, Local dynamic stability as a responsive index for the evaluation of rehabilitation effect on fall risk in patients with multiple sclerosis: a longitudinal study., BMC Res Notes, 2013, 6, 260, doi: 10.1186/1756-0500-6-260.