Multiple SclerosisNCT02421731
Robot-assisted Gait Training on Mobility in Severely Disabled Multiple Sclerosis Patients
A study testing Robot-assisted gait training and Conventional therapy in people with Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Gait disabilities affect personal activities and quality of life of progressive multiple sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of walking movements and imitation of a nearly normal gait pattern during treadmill training at a higher speed has been developed and recently… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Robot-assisted gait training and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Feb 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe gait impairments defined as EDSS 6-7
- lack of EDSS worsening in the last 3 months
Who cannot join
- neurologic conditions in addition to MS that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
- impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
- spasticity (Ashworth scale >3) or contractures that may limit range of motion or function
- changes in disease modifying drug therapy or in any other confounding factor during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Robot-assisted Gait Training Versus Conventional Therapy on Mobility in Severely Disabled Multiple Sclerosis Patients
Gait disabilities affect personal activities and quality of life of progressive multiple sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of walking movements and imitation of a nearly normal gait pattern during treadmill training at a higher speed has been developed and recently introduced in clinical settings. However, until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group of stroke, spinal cord injury and MS subjects.
In addition, the training-induced neural and biological changes potentially related to the mechanisms of recovery remain undefined.
Read more
The primary aims of this study are:
to test the feasibility of RAGT in a group of progressive severely disabled MS patients and to test the hypothesis that this intensive intervention could have higher benefit, compared with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot Walk (T25FW)
The secondary aims of this study are:
to determine whether fatigue, Quality of life, balance and locomotor function are improved by RAGT; to determine whether gait training influences markers of plasticity including clinical and circulating biomarkers to search for a possible correlation between clinical outcomes and clinical and circulating biomarkers
Read the detailed description
This is a prospective, randomized, single-blinded, controlled study. Ninety-eight MS subjects will be recruited from the identification of subjects at U.O. Rehabilitative Medicine and Rare Diseases and Neuroimmune Center, IRCCS Neurosciences "Bellaria" (BO).
After evaluation of their eligibility and when obtained the informed consent, patients will be enrolled and randomized to the two groups through a randomization stratification approach. Subjects will be grouped into strata defined by the degree of impairment (e.g. using outcomes from the Expanded Disability Status Scale or EDSS) and then randomized separately within each stratum according to a block randomization and will be assigned to one of the two treatment groups:
- robot-assisted gait training (experimental group)
- conventional therapy (control group)
Robot-assisted gait training:
Patients will receive 12 training sessions over 4 weeks (3 sessions/week) of RAGT. During these sessions subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these training parameters according to subject characteristics and demand level. As training will progress, adjustments in the assistance provided by the driven-gait orthosis, the amount of body weight support and treadmill speed will be performed. Training sessions will last for an hour with 30 minutes of real walking time, because subject set-up in the device take approximately 30 minutes.
Conventional therapy:
The control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed.
Outcome measures Outcome measures will be assessed a week before the treatment initiation (T0), after two weeks (T1), after 4 weeks (T2) and at 3 months follow-up (T3). Personnel blinded to the treatment will assess the effects of the intervention.
- Conditions
- Multiple Sclerosis
- Being tested
- Robot-assisted gait training, Conventional therapy
- Keywords
- Rehabilitation, Gait
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted gait trainingDevice
Patients will receive 12 training sessions, lasting for an hour with 30 minutes of real walking time, over 4 weeks (3 sessions/week) of RAGT. Subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these parameters according to subject characteristics and demand level. As training will progress, adjustments in the three parameters previously described will be performed.
Conventional therapyOther
The control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted gait training | Experimental | This group will receive rehabilitation treatment based on robot-assisted gait training. Receives: Device: Robot-assisted gait training |
| Conventional therapy | Active comparator | This group will receive conventional rehabilitation therapy. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed 25 Foot Walk
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet (7.62m) as quickly as possible, but safely, using the prescribed assistive devices.
Measured: weeks: 0,2,4,16
Secondary outcomes (9)
Six-Minute Walking Test
The walking endurance is measured with the Six-Minute Walking Test. This test, first validated in subjects with cardio-pulmonary problems, is considered a feasible, reproducible and reliable measure also in MS. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary.
Measured: weeks: 0,2,4,16
Berg Balance Scale
This is an assessment scale of ability to maintain balance, or statically or while performing functional movement, including 14 observable tasks common to everyday life measured on a 5 point ordinal scale.
Measured: weeks: 0,2,4,16
Up and Go Test
Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch.
Measured: weeks: 0,2,4,16
Fatigue Severity Scale
The Fatigue Severity Scale is a method of evaluating fatigue in MS and other conditions. Essentially, the Fatigue Severity Scale consists of answering a short questionnaire that requires the subject to to read each statement and rate his or her own level of fatigue from 1 to 7, depending on how appropriate they felt the statement applied to them over the preceding week.
Measured: weeks: 0,2,4,16
Modified Ashworth Scale
This is a 6-point measure of spasticity. We will assess the spasticity at the hip, knee and ankle (flexors and extensors muscles).
Measured: weeks: 0,2,4,16
Short-Form 36
This is an assessment tool of quality of life.
Measured: weeks: 0,2,4,16
Haemodynamic measurements
Doppler venous flow volume measurement, with evaluation of the thoracic pump; postural control of cerebral venous return assessed by plethysmography5; venous haemodynamics insufficiency severity score will be also evaluated and calculated.
Measured: weeks: 0,2,4,16
Metabolic measurements by Near infrared spectroscopy
Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks. Patients will walk on the treadmill at a speed of 0.2 km/h assisted by personnel and with partial body weight support, performing 4 short tasks (30 seconds of walking) alternated by rest periods (30 seconds).
Measured: weeks: 0,2,4,16
Circulating biomarkers
blood biomarker levels modifications
Measured: weeks: 0,2,4,16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Emilia-Romagna, Università degli Studi di Ferrara
- Responsible party
- Sponsor
- Investigators
- Sofia Straudi, MD, Principal investigator, Ferrara Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421731
- Sponsor's protocol ID
- Regionale WP3
- Status last verified
- Feb 2017
- First submitted
- 19 Jan 2015
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Manfredini F, Straudi S, Lamberti N, Patergnani S, Tisato V, Secchiero P, Bernardi F, Ziliotto N, Marchetti G, Basaglia N, Bonora M, Pinton P. Rehabilitation Improves Mitochondrial Energetics in Progressive Multiple Sclerosis: The Significant Role of Robot-Assisted Gait Training and of the Personalized Intensity. Diagnostics (Basel). 2020 Oct 17;10(10):834. doi: 10.3390/diagnostics10100834.
PubMed 33080806Straudi S, Manfredini F, Lamberti N, Martinuzzi C, Maietti E, Basaglia N. Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial. Mult Scler. 2020 May;26(6):716-724. doi: 10.1177/1352458519833901. Epub 2019 Mar 4.
PubMed 30829117Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.
PubMed 28241776
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Robot-assisted Gait Training Versus Conventional Therapy on Mobility in Severely Disabled Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT02421731
- Acronym / sponsor ID
- Regionale WP3
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Regione Emilia-Romagna, Università degli Studi di Ferrara
- Study start
- Feb 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 21 Apr 2015 (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.
Gait disabilities affect personal activities and quality of life of progressive multiple sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of walking movements and imitation of a nearly normal gait pattern during treadmill training at a higher speed has been developed and recently introduced in clinical settings. However, until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group of stroke, spinal cord injury and MS subjects.
In addition, the training-induced neural and biological changes potentially related to the mechanisms of recovery remain undefined.
The primary aims of this study are:
to test the feasibility of RAGT in a group of progressive severely disabled MS patients and to test the hypothesis that this intensive intervention could have higher benefit, compared with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot Walk (T25FW)
The secondary aims of this study are:
to determine whether fatigue, Quality of life, balance and locomotor function are improved by RAGT; to determine whether gait training influences markers of plasticity including clinical and circulating biomarkers to search for a possible correlation between clinical outcomes and clinical and circulating biomarkers
Detailed description
This is a prospective, randomized, single-blinded, controlled study. Ninety-eight MS subjects will be recruited from the identification of subjects at U.O. Rehabilitative Medicine and Rare Diseases and Neuroimmune Center, IRCCS Neurosciences "Bellaria" (BO).
After evaluation of their eligibility and when obtained the informed consent, patients will be enrolled and randomized to the two groups through a randomization stratification approach. Subjects will be grouped into strata defined by the degree of impairment (e.g. using outcomes from the Expanded Disability Status Scale or EDSS) and then randomized separately within each stratum according to a block randomization and will be assigned to one of the two treatment groups:
- robot-assisted gait training (experimental group)
- conventional therapy (control group)
Robot-assisted gait training:
Patients will receive 12 training sessions over 4 weeks (3 sessions/week) of RAGT. During these sessions subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these training parameters according to subject characteristics and demand level. As training will progress, adjustments in the assistance provided by the driven-gait orthosis, the amount of body weight support and treadmill speed will be performed. Training sessions will last for an hour with 30 minutes of real walking time, because subject set-up in the device take approximately 30 minutes.
Conventional therapy:
The control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed.
Outcome measures Outcome measures will be assessed a week before the treatment initiation (T0), after two weeks (T1), after 4 weeks (T2) and at 3 months follow-up (T3). Personnel blinded to the treatment will assess the effects of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted gait training | Experimental | Device: Robot-assisted gait trainingThis group will receive rehabilitation treatment based on robot-assisted gait training. |
| Conventional therapy | Active comparator | Other: Conventional therapyThis group will receive conventional rehabilitation therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- severe gait impairments defined as EDSS 6-7
- lack of EDSS worsening in the last 3 months
Key exclusion criteria (4 listed)
- neurologic conditions in addition to MS that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
- impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
- spasticity (Ashworth scale >3) or contractures that may limit range of motion or function
- changes in disease modifying drug therapy or in any other confounding factor during the study.
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 |
|---|---|---|
| Robot-assisted gait trainingPatients will receive 12 training sessions, lasting for an hour with 30 minutes of real walking time, over 4 weeks (3 sessions/week) of RAGT. Subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these parameters according to subject characteristics and demand level. As training will progress, adjustments in the three parameters previously described will be performed. | Device | Robot-assisted gait training |
| Conventional therapyThe control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed. | Other | Conventional therapy |
Primary outcome
Timed 25 Foot Walk
Time frame: weeks: 0,2,4,16
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet (7.62m) as quickly as possible, but safely, using the prescribed assistive devices.
9 secondary outcomes
Six-Minute Walking Test
Time frame: weeks: 0,2,4,16
Berg Balance Scale
Time frame: weeks: 0,2,4,16
Up and Go Test
Time frame: weeks: 0,2,4,16
Fatigue Severity Scale
Time frame: weeks: 0,2,4,16
Modified Ashworth Scale
Time frame: weeks: 0,2,4,16
Short-Form 36
Time frame: weeks: 0,2,4,16
Haemodynamic measurements
Time frame: weeks: 0,2,4,16
Metabolic measurements by Near infrared spectroscopy
Time frame: weeks: 0,2,4,16
Circulating biomarkers
Time frame: weeks: 0,2,4,16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 33080806Manfredini F, Straudi S, Lamberti N, Patergnani S, Tisato V, Secchiero P, Bernardi F, Ziliotto N, Marchetti G, Basaglia N, Bonora M, Pinton P. Rehabilitation Improves Mitochondrial Energetics in Progressive Multiple Sclerosis: The Significant Role of Robot-Assisted Gait Training and of the Personalized Intensity. Diagnostics (Basel). 2020 Oct 17;10(10):834. doi: 10.3390/diagnostics10100834.
- Derived from this study: PubMed 30829117Straudi S, Manfredini F, Lamberti N, Martinuzzi C, Maietti E, Basaglia N. Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial. Mult Scler. 2020 May;26(6):716-724. doi: 10.1177/1352458519833901. Epub 2019 Mar 4.
- Derived from this study: PubMed 28241776Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.
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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.
Sofia Straudi, MD principal investigator
Ferrara Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted gait training and Conventional therapy in people with Multiple Sclerosis, run by University Hospital of Ferrara 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25 Foot Walk (time frame: weeks: 0,2,4,16). 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 NCT02421731, which also lists 3 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 8 Feb 2023.