Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, gait rehabilitation
Brief 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. 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.
Interventions
BEHAVIORALLokomat (Hocoma, Switzerland)
BEHAVIORALConventional Therapy
Sponsors
Azienda Ospedaliero, Universitaria Pisana
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| motor unit firing rate characteristics | 12 months | It will be performed through the analysis of superficial EMG signals during isometric knee extension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mobility | 12 months | Timed Up and Go Test |
| balance | 12 months | Berg Balance Test |
| gait speed | 12 months | 10 meter test |
| walking endurance | 12 months | six minute walking test |
| quality of life | 12 months | SF-36 |
| depression | 12 months | patient health questionnaire (PHQ-9) |
| Fatigue | 12 months | Fatigue Severy Scale |
Countries
Italy
Outcome results
None listed