Multiple SclerosisNCT02291107
Robot-assisted Gait Training in Patients With Multiple Sclerosis: Efficacy and Comparison With Traditional Methods
A study testing Lokomat (Hocoma, Zurich, Switzerland) and Conventional Physiotherapy in people with Multiple Sclerosis, run by Habilita, Ospedale di Sarnico at 1 site in Italy.
Trial summary
In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Lokomat (Hocoma, Zurich, Switzerland) and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of multiple sclerosis according to the McDonald's Criteria in stable phase of disease for at least 3 months.
- ability to walk 25 foot without assistance
- EDSS score between 3.5 and 7
Who cannot join
- exacerbations of the disease in the last 3 months
- deficits of somatic sensation involving the legs
- other neurological, orthopedic or cardiovascular co-morbility
- severe posture abnormalities
- severe-moderate cognitive impairment (Mini Mental State ≤ 21)
- body weight greater than 135 kg;
Show all 9Show fewer
- height more than 200 cm;
- limb-length discrepancy greater than 2 cm;
- presence of skin lesions on the trunk, pelvis and lower limbs that could interfere with the placement of the electrodes and straps anchoring the Lokomat.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
HABILITA
Zingonia Di Ciserano, Bergamo, 24040
Paola Sabattini, 0354815515, paolasabattini@habilita.it
About this study
Official title: Robot-assisted Gait Training in Patients Affected by Multiple Sclerosis: Rehabilitative Efficacy Evaluation and Comparison With Traditional Methods
In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. Current promising rehabilitative approaches for neurological disorders are based on the concept of the task-specific repetitive training. Hence, the interest in automated robotic devices that allow this typology of treatment for gait training. However, studies on the effectiveness of such methodologies are still poorly numerous in terms of functional improvement in MS patients. The aim of this controlled cross-over study is to evaluate the effectiveness of a Lokomat gait training in patients affected by Multiple Sclerosis in comparison to a ground conventional gait training.
Read the detailed description
In Multiple Sclerosis (MS), the highly variable distribution of demyelinization areas and axonal loss in the Central Nervous System can lead to very complex and unpredictable neurological deficits and clinical patterns. Gait disorders as reduced speed and stride length, gait asymmetry, increased muscular energy expenditure, balance deficit and increased risk of falling, represent one of the most disabling aspect. These motor problems strongly influence the level of independence that a person affected by MS is able to achieve, resulting in severe negative impact on quality of life. Therefore, the improvement of walking ability is a primary goal for rehabilitation treatment. Many studies demonstrated that a conventional rehabilitation treatment based on physiotherapy could be effective in increasing muscle strength and motor function, improving gait and mobility abilities, reducing fatigue and risk of falls, leading finally to an overall increase of patient autonomy. According to the most recent neurophysiological concepts based on neural plasticity, in recent years the rehabilitative approaches that seem to be more effective in improving functional performance are based on the concept of the task-specific repetitive training. As in the case of the constraint induced movement therapy (CIMT) for upper limb rehabilitation and the body weight support treadmill training (BWSTT) for the lower, the factors that appear to positively affect patient outcome are the intensity, precocity, repeatability, specificity in a training that incorporates high numbers of repetitions of task-oriented practice. Hence, the interest in automated robotic devices for gait training for MS patients has grown. With their consistent, symmetrical lower-limb trajectories, robotic devices provide many of the proprioceptive inputs that may increase cortical activation and stimulation of Central Pattern Generator (CGPs) in order to improve motor function. The use of robot-assisted-gait-training (RAGT) allows: repetition of specific and stereotyped movements in order to acquire a correct and reproducible gait pattern in conditions of balance and symmetry, early start of treatment using the activity with body weight support, safeguard of the patient with reduction of fear of falling, in order to increase the quantity and quality of the performed exercise while minimizing the intervention of a therapist. However, studies on the effectiveness of such methodologies are still poorly numerous in terms of functional improvement in patients with MS. The aim of this controlled cross-over study is to evaluate the effectiveness of a robot-driven gait orthosis (Lokomat - Hocoma, Inc., Zurich, Switzerland) gait training in patients affected by Multiple Sclerosis in comparison to a ground conventional gait training. The improvement in gait pattern, motor ability and autonomy in the functional activities of daily living will be assessed by using validated clinical and functional scales and quantitative instrumental analysis of gait kinematic parameters
- Conditions
- Multiple Sclerosis
- Being tested
- Lokomat (Hocoma, Zurich, Switzerland), Conventional Physiotherapy
- Keywords
- Gait orthosis, Lokomat, Robotic Rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat (Hocoma, Zurich, Switzerland)Device
Patients allocated to the Experimental group performed a Robotic Assisted Gait Training by means of the Lokomat. The Lokomat is robotic device set up as an exoskeleton on the lower limbs of the patient. The system uses a dynamic body weight-support system to support he participant above a motorized treadmill synchronized with the Lokomat.
Conventional PhysiotherapyOther
Patients allocated to the Control Group performed a general exercise program and a conventional gait training. The same trained therapist treated all the patients in this group and standardized the duration of each part of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants received 25 sessions of robotically driven gait orthosis training on the Lokomat. Training occurred approximately 5 days/ week for 5 weeks, and each training session on the Lokomat lasted 30 minutes. All sessions were supervised by a trained research therapist. All participants started with 40% body weight-support and an initial treadmill speed of 1.5 km/h. Body weight-support was used primarily to facilitate an increase in walking speed; therefore, progression of training across subsequent sessions was standardized by preferentially increasing speed and then unloading body weight-support. Speed was increased to a range of 2.2 to 2.5 km/h before body weight-support was decreased. There was an active attempt to enhance the level of training at each session. After every Lokomat session, participants performed also 60 minutes of physiotherapy including general exercise program and a conventional gait training Receives: Device: Lokomat (Hocoma, Zurich, Switzerland) |
| Control group | Active comparator | Participants received 25 sessions of conventional physiotherapy. Training occurred approximately 5 days/week for 5 weeks, and each training session lasted 1 hour and half. Patients allocated to the Control Group performed the same conventional physiotherapy training of the other group: a general exercise program and a conventional gait training. The general exercise program consisted in cardiovascular warm-up exercises, muscle stretching exercises, active-assisted or active isometric and isotonic exercises for the main muscles of the trunk and limbs, relaxation exercises, coordination and static/dynamic balance exercises. The conventional gait therapy was based on the proprioceptive neuromuscular facilitation concept, training in walking on different surfaces with or without appropriate walking aids, exercises for the restoration of a correct gait pattern, implementation of residual compensatory strategies and progressive increase of walking resistance Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed 25 Foot Walk (25FW)
Assessment of gait performance in terms of speed. First component of the Multiple Sclerosis Functional Composite (MSCF) scale - leg function / ambulation, for the study and measurement of functional outcomes in clinical trials in patients with multiple sclerosis according to the "Task Force on Clinical Outcomes Assessment of the National Multiple Sclerosis Society "- 1994.
Measured: 5 weeks
Secondary outcomes (13)
Timed 10 meter walking test (TWT)
Assessment of gait performance in terms of speed
Measured: 5 weeks
6 minute walking test (6MWT)
Assessment of gait performance in terms of resistance
Measured: 5 weeks
Tinetti Test (TT)
Assessment of balance and gait ability and the falls risk
Measured: 5 weeks
Functional Ambulation Categories (FAC)
Assessment of ambulation ability
Measured: 5 weeks
Modified Ashworth scale for lower limbs
Assessment of lower limbs spasticity
Measured: 5 weeks
Modified Motricity Index for lower limbs
Assessment of lower limbs motor function
Measured: 5 weeks
Knee extensor strength (KES)
Assessment of knee extensor strength by dynamometer measurement
Measured: 5 weeks
Double Time Support (DST)
kinematic parameter corresponding to the duration of the double support phase of gait cycle, calculated as [ms /%]
Measured: 5 weeks
Step Length Ratio (SLR)
kinematic parameter corresponding to gait symmetry, calculated as the ratio between the step length of both legs (shorter step length / longer step length)
Measured: 5 weeks
Expanded Disability Status Scale (EDSS)
Traditionally used disability scale for multiple sclerosis
Measured: 5 weeks
Functional Independence Measure (FIM)
Assessment of daily activities functional autonomy
Measured: 5 weeks
Quality of Life Index (QL Index - SF36)
Measures of health-related quality of life
Measured: 5 weeks
Numeric Rating Scale (NRS)
Assessment of pain
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habilita, Ospedale di Sarnico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cristiano Sconza, Habilita, Ospedale di Sarnico
- Investigators
- Umberto Bonassi, MD, Study chair, HABILITA ZingoniaCristiano Sconza, MD, Principal investigator, HABILITA Zingonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291107
- Sponsor's protocol ID
- LK.S P07
- Status last verified
- Aug 2015
- First submitted
- 11 Nov 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwartz I, Sajin A, Moreh E, Fisher I, Neeb M, Forest A, Vaknin-Dembinsky A, Karusis D, Meiner Z. Robot-assisted gait training in multiple sclerosis patients: a randomized trial. Mult Scler. 2012 Jun;18(6):881-90. doi: 10.1177/1352458511431075. Epub 2011 Dec 6.
PubMed 22146609Beer S, Aschbacher B, Manoglou D, Gamper E, Kool J, Kesselring J. Robot-assisted gait training in multiple sclerosis: a pilot randomized trial. Mult Scler. 2008 Mar;14(2):231-6. doi: 10.1177/1352458507082358. Epub 2007 Oct 17.
PubMed 17942510Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473.
PubMed 18971381Swinnen E, Beckwee D, Pinte D, Meeusen R, Baeyens JP, Kerckhofs E. Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. Mult Scler Int. 2012;2012:240274. doi: 10.1155/2012/240274. Epub 2012 May 30.
PubMed 22701177Vaney 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. 2012 Mar-Apr;26(3):212-21. doi: 10.1177/1545968311425923. Epub 2011 Dec 2.
PubMed 22140197Wier LM, Hatcher MS, Triche EW, Lo AC. Effect of robot-assisted versus conventional body-weight-supported treadmill training on quality of life for people with multiple sclerosis. J Rehabil Res Dev. 2011;48(4):483-92. doi: 10.1682/jrrd.2010.03.0035.
PubMed 21674396Pilutti LA, Lelli DA, Paulseth JE, Crome M, Jiang S, Rathbone MP, Hicks AL. Effects of 12 weeks of supported treadmill training on functional ability and quality of life in progressive multiple sclerosis: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92(1):31-6. doi: 10.1016/j.apmr.2010.08.027.
PubMed 21187202Giesser B, Beres-Jones J, Budovitch A, Herlihy E, Harkema S. Locomotor training using body weight support on a treadmill improves mobility in persons with multiple sclerosis: a pilot study. Mult Scler. 2007 Mar;13(2):224-31. doi: 10.1177/1352458506070663.
PubMed 17450642Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.
PubMed 12732691
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Gait Training in Patients Affected by Multiple Sclerosis: Rehabilitative Efficacy Evaluation and Comparison With Traditional Methods
- ClinicalTrials.gov ID
- NCT02291107
- Acronym / sponsor ID
- LK.S P07
- Conditions
- Multiple Sclerosis
- Keywords
- Gait orthosis, Lokomat, Robotic Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Habilita, Ospedale di SarnicoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. Current promising rehabilitative approaches for neurological disorders are based on the concept of the task-specific repetitive training. Hence, the interest in automated robotic devices that allow this typology of treatment for gait training. However, studies on the effectiveness of such methodologies are still poorly numerous in terms of functional improvement in MS patients. The aim of this controlled cross-over study is to evaluate the effectiveness of a Lokomat gait training in patients affected by Multiple Sclerosis in comparison to a ground conventional gait training.
Detailed description
In Multiple Sclerosis (MS), the highly variable distribution of demyelinization areas and axonal loss in the Central Nervous System can lead to very complex and unpredictable neurological deficits and clinical patterns. Gait disorders as reduced speed and stride length, gait asymmetry, increased muscular energy expenditure, balance deficit and increased risk of falling, represent one of the most disabling aspect. These motor problems strongly influence the level of independence that a person affected by MS is able to achieve, resulting in severe negative impact on quality of life. Therefore, the improvement of walking ability is a primary goal for rehabilitation treatment. Many studies demonstrated that a conventional rehabilitation treatment based on physiotherapy could be effective in increasing muscle strength and motor function, improving gait and mobility abilities, reducing fatigue and risk of falls, leading finally to an overall increase of patient autonomy. According to the most recent neurophysiological concepts based on neural plasticity, in recent years the rehabilitative approaches that seem to be more effective in improving functional performance are based on the concept of the task-specific repetitive training. As in the case of the constraint induced movement therapy (CIMT) for upper limb rehabilitation and the body weight support treadmill training (BWSTT) for the lower, the factors that appear to positively affect patient outcome are the intensity, precocity, repeatability, specificity in a training that incorporates high numbers of repetitions of task-oriented practice. Hence, the interest in automated robotic devices for gait training for MS patients has grown. With their consistent, symmetrical lower-limb trajectories, robotic devices provide many of the proprioceptive inputs that may increase cortical activation and stimulation of Central Pattern Generator (CGPs) in order to improve motor function. The use of robot-assisted-gait-training (RAGT) allows: repetition of specific and stereotyped movements in order to acquire a correct and reproducible gait pattern in conditions of balance and symmetry, early start of treatment using the activity with body weight support, safeguard of the patient with reduction of fear of falling, in order to increase the quantity and quality of the performed exercise while minimizing the intervention of a therapist. However, studies on the effectiveness of such methodologies are still poorly numerous in terms of functional improvement in patients with MS. The aim of this controlled cross-over study is to evaluate the effectiveness of a robot-driven gait orthosis (Lokomat - Hocoma, Inc., Zurich, Switzerland) gait training in patients affected by Multiple Sclerosis in comparison to a ground conventional gait training. The improvement in gait pattern, motor ability and autonomy in the functional activities of daily living will be assessed by using validated clinical and functional scales and quantitative instrumental analysis of gait kinematic parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Lokomat (Hocoma, Zurich, Switzerland)Participants received 25 sessions of robotically driven gait orthosis training on the Lokomat. Training occurred approximately 5 days/ week for 5 weeks, and each training session on the Lokomat lasted 30 minutes. All sessions were supervised by a trained research therapist. All participants started with 40% body weight-support and an initial treadmill speed of 1.5 km/h. Body weight-support was used primarily to facilitate an increase in walking speed; therefore, progression of training across subsequent sessions was standardized by preferentially increasing speed and then unloading body weight-support. Speed was increased to a range of 2.2 to 2.5 km/h before body weight-support was decreased. There was an active attempt to enhance the level of training at each session. After every Lokomat session, participants performed also 60 minutes of physiotherapy including general exercise program and a conventional gait training |
| Control group | Active comparator | Other: Conventional PhysiotherapyParticipants received 25 sessions of conventional physiotherapy. Training occurred approximately 5 days/week for 5 weeks, and each training session lasted 1 hour and half. Patients allocated to the Control Group performed the same conventional physiotherapy training of the other group: a general exercise program and a conventional gait training. The general exercise program consisted in cardiovascular warm-up exercises, muscle stretching exercises, active-assisted or active isometric and isotonic exercises for the main muscles of the trunk and limbs, relaxation exercises, coordination and static/dynamic balance exercises. The conventional gait therapy was based on the proprioceptive neuromuscular facilitation concept, training in walking on different surfaces with or without appropriate walking aids, exercises for the restoration of a correct gait pattern, implementation of residual compensatory strategies and progressive increase of walking resistance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of multiple sclerosis according to the McDonald's Criteria in stable phase of disease for at least 3 months.
- ability to walk 25 foot without assistance
- EDSS score between 3.5 and 7
Key exclusion criteria (9 listed)
- exacerbations of the disease in the last 3 months
- deficits of somatic sensation involving the legs
- other neurological, orthopedic or cardiovascular co-morbility
- severe posture abnormalities
- severe-moderate cognitive impairment (Mini Mental State ≤ 21)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lokomat (Hocoma, Zurich, Switzerland)Patients allocated to the Experimental group performed a Robotic Assisted Gait Training by means of the Lokomat. The Lokomat is robotic device set up as an exoskeleton on the lower limbs of the patient. The system uses a dynamic body weight-support system to support he participant above a motorized treadmill synchronized with the Lokomat. | Device | Experimental group |
| Conventional PhysiotherapyPatients allocated to the Control Group performed a general exercise program and a conventional gait training. The same trained therapist treated all the patients in this group and standardized the duration of each part of the treatment. | Other | Control group |
Primary outcome
Timed 25 Foot Walk (25FW)
Time frame: 5 weeks
Assessment of gait performance in terms of speed. First component of the Multiple Sclerosis Functional Composite (MSCF) scale - leg function / ambulation, for the study and measurement of functional outcomes in clinical trials in patients with multiple sclerosis according to the "Task Force on Clinical Outcomes Assessment of the National Multiple Sclerosis Society "- 1994.
13 secondary outcomes
Timed 10 meter walking test (TWT)
Time frame: 5 weeks
6 minute walking test (6MWT)
Time frame: 5 weeks
Tinetti Test (TT)
Time frame: 5 weeks
Functional Ambulation Categories (FAC)
Time frame: 5 weeks
Modified Ashworth scale for lower limbs
Time frame: 5 weeks
Modified Motricity Index for lower limbs
Time frame: 5 weeks
Knee extensor strength (KES)
Time frame: 5 weeks
Double Time Support (DST)
Time frame: 5 weeks
Step Length Ratio (SLR)
Time frame: 5 weeks
Expanded Disability Status Scale (EDSS)
Time frame: 5 weeks
Functional Independence Measure (FIM)
Time frame: 5 weeks
Quality of Life Index (QL Index - SF36)
Time frame: 5 weeks
Numeric Rating Scale (NRS)
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Results publication: PubMed 22146609Schwartz I, Sajin A, Moreh E, Fisher I, Neeb M, Forest A, Vaknin-Dembinsky A, Karusis D, Meiner Z. Robot-assisted gait training in multiple sclerosis patients: a randomized trial. Mult Scler. 2012 Jun;18(6):881-90. doi: 10.1177/1352458511431075. Epub 2011 Dec 6.
- Results publication: PubMed 17942510Beer S, Aschbacher B, Manoglou D, Gamper E, Kool J, Kesselring J. Robot-assisted gait training in multiple sclerosis: a pilot randomized trial. Mult Scler. 2008 Mar;14(2):231-6. doi: 10.1177/1352458507082358. Epub 2007 Oct 17.
- Results publication: PubMed 18971381Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473.
- Results publication: PubMed 22701177Swinnen E, Beckwee D, Pinte D, Meeusen R, Baeyens JP, Kerckhofs E. Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. Mult Scler Int. 2012;2012:240274. doi: 10.1155/2012/240274. Epub 2012 May 30.
- Results publication: PubMed 22140197Vaney 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. 2012 Mar-Apr;26(3):212-21. doi: 10.1177/1545968311425923. Epub 2011 Dec 2.
- Results publication: PubMed 21674396Wier LM, Hatcher MS, Triche EW, Lo AC. Effect of robot-assisted versus conventional body-weight-supported treadmill training on quality of life for people with multiple sclerosis. J Rehabil Res Dev. 2011;48(4):483-92. doi: 10.1682/jrrd.2010.03.0035.
- Results publication: PubMed 21187202Pilutti LA, Lelli DA, Paulseth JE, Crome M, Jiang S, Rathbone MP, Hicks AL. Effects of 12 weeks of supported treadmill training on functional ability and quality of life in progressive multiple sclerosis: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92(1):31-6. doi: 10.1016/j.apmr.2010.08.027.
- Results publication: PubMed 17450642Giesser B, Beres-Jones J, Budovitch A, Herlihy E, Harkema S. Locomotor training using body weight support on a treadmill improves mobility in persons with multiple sclerosis: a pilot study. Mult Scler. 2007 Mar;13(2):224-31. doi: 10.1177/1352458506070663.
- Results publication: PubMed 12732691Eng J. Sample size estimation: how many individuals should be studied? Radiology. 2003 May;227(2):309-13. doi: 10.1148/radiol.2272012051.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto Bonassi, MD study chair
HABILITA Zingonia
Cristiano Sconza, MD principal investigator
HABILITA Zingonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat (Hocoma, Zurich, Switzerland) and Conventional Physiotherapy in people with Multiple Sclerosis, run by Habilita, Ospedale di Sarnico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristiano Sconza, MD (0354815515, cristiano.sconza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25 Foot Walk (25FW) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291107, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015; AzTrials last refreshed its copy on 1 Nov 2026.