Multiple SclerosisNCT01435694
Robot-assisted Gait Training in Multiple Sclerosis Subjects
A study testing Lokomat (Hocoma, Switzerland) and Conventional Therapy in people with Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Aims of the study: This is a randomized-controlled trial to test the effects of robot-assisted gait training on locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait impairments. The control group will be treat with conventional physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Lokomat (Hocoma, Switzerland) and Conventional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to Jun 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females, community dwelling, age 18 or older
- diagnosis of multiple sclerosis in a stable phase, with relapses > 6 months prior to study enrollment
- moderate to severe gait impairments referred to Expanded Disability Status Scale (EDSS) between 6 and 7
Who cannot join
- neurologic conditions in addition to multiple sclerosis that may affect motor function
- medical conditions likely to interfere with the ability to safely complete the study
- impaired cognitive functioning: Mini Mental Status Examination < 24
- severe lower-extremities spasticity or contractures that may limit range of motion(Ashworth score >4 for hip, knee or ankle flexors/extensors
Trial locations and contacts
1 site in 1 country.
Italy1 site
Physical Medicine and Rehabilitation Department
Ferrara, Ferrara, 44100
About this study
Official title: The Effects of Robot-assisted Gait Training on Locomotor Function and Motor Unit Firing in Multiple Sclerosis Subjects With Severe Gait Impairments. A Randomized Control Trial
Aims of the study:
This is a randomized-controlled trial to test the effects of robot-assisted gait training on locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait impairments. The control group will be treat with conventional physical therapy.
Read more
Subjects and methods:
60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.
Informed consent will be obtained. Participants will be randomized to Robot-assisted gait training (experimental group) or conventional therapy (control group) through a randomization stratification approach, according to a block randomization of 4.
The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2 sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks (2 sessions/week), that will focus on gait training.
Primary outcome measures will be both neurophysiological measures (motor unit firing rate characteristics) and clinical test for gait speed (10m walking test). Secondary outcome measures will include: clinical tests of walking endurance (six minute walking test), balance (Berg Balance Test) and mobility (Up and Go Test).
Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored. Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale. Outcome measures will be assessed the week prior to treatment initiation (T0), after 6 sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.
- Conditions
- Multiple Sclerosis
- Being tested
- Lokomat (Hocoma, Switzerland), Conventional Therapy
- Keywords
- multiple sclerosis, gait 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, Switzerland)Behavioural
Also called robotic-driven gait orthosis
Conventional TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted gait training | Experimental | 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%. 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. Receives: Behavioral: Lokomat (Hocoma, Switzerland) |
| Conventional Therapy | Active comparator | Training sessions will focus on locomotor function improvements. Subjects will receive 45 minutes 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 they will be trained on walking abilities (like walking at different speeds, rapid changes directions) for 30 minutes with or without assistive aids. Receives: Behavioral: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor unit firing rate characteristics
It will be performed through the analysis of superficial EMG signals during isometric knee extension.
Measured: 12 months
Secondary outcomes (7)
walking endurance
six minute walking test
Measured: 12 months
mobility
Timed Up and Go Test
Measured: 12 months
balance
Berg Balance Test
Measured: 12 months
gait speed
10 meter test
Measured: 12 months
Fatigue
Fatigue Severy Scale
Measured: 12 months
quality of life
SF-36
Measured: 12 months
depression
patient health questionnaire (PHQ-9)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Principal investigator, Sofia Straudi, MD, University Hospital of Ferrara
- Investigators
- Sofia Straudi, MD, Study chair, Ferrara University HospitalCarmelo Chisari, MD, Study chair, Pisana University HospitalNino Basaglia, MD, Principal investigator, Ferrara University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435694
- Sponsor's protocol ID
- FISM_grant_2010
- Status last verified
- Jan 2014
- First submitted
- 14 Sep 2011
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Robot-assisted Gait Training on Locomotor Function and Motor Unit Firing in Multiple Sclerosis Subjects With Severe Gait Impairments. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01435694
- Acronym / sponsor ID
- FISM_grant_2010
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, gait rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Sep 2011 (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.
Aims of the study:
This is a randomized-controlled trial to test the effects of robot-assisted gait training on locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait impairments. The control group will be treat with conventional physical therapy.
Subjects and methods:
60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.
Informed consent will be obtained. Participants will be randomized to Robot-assisted gait training (experimental group) or conventional therapy (control group) through a randomization stratification approach, according to a block randomization of 4.
The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2 sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks (2 sessions/week), that will focus on gait training.
Primary outcome measures will be both neurophysiological measures (motor unit firing rate characteristics) and clinical test for gait speed (10m walking test). Secondary outcome measures will include: clinical tests of walking endurance (six minute walking test), balance (Berg Balance Test) and mobility (Up and Go Test).
Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored. Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale. Outcome measures will be assessed the week prior to treatment initiation (T0), after 6 sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.
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 | Behavioral: Lokomat (Hocoma, Switzerland)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%. 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 | Active comparator | Behavioral: Conventional TherapyTraining sessions will focus on locomotor function improvements. Subjects will receive 45 minutes 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 they will be trained on walking abilities (like walking at different speeds, rapid changes directions) for 30 minutes with or without assistive aids. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- males and females, community dwelling, age 18 or older
- diagnosis of multiple sclerosis in a stable phase, with relapses > 6 months prior to study enrollment
- moderate to severe gait impairments referred to Expanded Disability Status Scale (EDSS) between 6 and 7
Key exclusion criteria (4 listed)
- neurologic conditions in addition to multiple sclerosis that may affect motor function
- medical conditions likely to interfere with the ability to safely complete the study
- impaired cognitive functioning: Mini Mental Status Examination < 24
- severe lower-extremities spasticity or contractures that may limit range of motion(Ashworth score >4 for hip, knee or ankle flexors/extensors
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, Switzerland)Also: robotic-driven gait orthosis | Behavioural | Robot-assisted gait training |
| Conventional Therapy | Behavioural | Conventional Therapy |
Primary outcome
motor unit firing rate characteristics
Time frame: 12 months
It will be performed through the analysis of superficial EMG signals during isometric knee extension.
7 secondary outcomes
walking endurance
Time frame: 12 months
mobility
Time frame: 12 months
balance
Time frame: 12 months
gait speed
Time frame: 12 months
Fatigue
Time frame: 12 months
quality of life
Time frame: 12 months
depression
Time frame: 12 months
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 16 Jan 2014.
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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 study chair
Ferrara University Hospital
Carmelo Chisari, MD study chair
Pisana University Hospital
Nino Basaglia, MD principal investigator
Ferrara University 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 Lokomat (Hocoma, Switzerland) 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 3 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 16 Jan 2014. 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?
motor unit firing rate characteristics (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2014.