- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435694
Robot-assisted Gait Training in Multiple Sclerosis Subjects
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ferrara, Italy, 44100
- Physical Medicine and Rehabilitation Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robot-assisted gait training
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.
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Other Names:
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Active Comparator: Conventional Therapy
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
motor unit firing rate characteristics
Time Frame: 12 months
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It will be performed through the analysis of superficial EMG signals during isometric knee extension.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gait speed
Time Frame: 12 months
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10 meter test
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12 months
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walking endurance
Time Frame: 12 months
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six minute walking test
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12 months
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mobility
Time Frame: 12 months
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Timed Up and Go Test
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12 months
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balance
Time Frame: 12 months
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Berg Balance Test
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12 months
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Fatigue
Time Frame: 12 months
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Fatigue Severy Scale
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12 months
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quality of life
Time Frame: 12 months
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SF-36
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12 months
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depression
Time Frame: 12 months
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patient health questionnaire (PHQ-9)
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nino Basaglia, MD, Ferrara University Hospital
- Study Chair: Sofia Straudi, MD, Ferrara University Hospital
- Study Chair: Carmelo Chisari, MD, Pisana University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FISM_grant_2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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