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Robot-assisted Gait Training in Multiple Sclerosis Subjects

NCT01435694 · University Hospital of Ferrara · Updated 16 Jan 2014

What is being tested
Lokomat (Hocoma, Switzerland); Conventional Therapy
For
Multiple Sclerosis
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 75 years. About 60 people. The full rules are on the registry page.
Where
Italy
When
Starts or started April 2011, ends June 2013. Registered 19 Sept 2011.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT01435694

Sites

  • Physical Medicine and Rehabilitation DepartmentFerrara, Ferrara, Italy