Condition category
Nervous System Diseases
Date applied
02/04/2007
Date assigned
10/09/2007
Last edited
12/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bernerklinik.ch/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes