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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	Lokomat (Hocoma, Switzerland)
BEHAVIORAL	Conventional Therapy

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-09-19
• Last updated: 2014-01-16

Locations

1 site across 1 country: Italy