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Robot-assisted Gait Training on Mobility in Severely Disabled Multiple Sclerosis Patients

NCT02421731 · University Hospital of Ferrara · Updated 8 Feb 2023

What is being tested
Robot-assisted gait training; 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 65 years. About 72 people. The full rules are on the registry page.
Where
Italy
When
Starts or started Feb 2014, ends Feb 2018. Registered 21 April 2015.
Results
None posted yet.

In the researchers' words

Gait disabilities affect personal activities and quality of life of progressive multiple sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of walking movements and imitation of a nearly normal gait pattern during treadmill training at a higher speed has been developed and recently introduced in clinical settings. However, until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group of stroke, spinal cord injury and MS subjects. In addition, the training-induced neural and biological changes potentially related to the mechanisms of recovery remain undefined. The primary aims of this study are: to test the feasibility of RAGT in a group of progressive severely disabled MS patients and to test the hypothesis that this intensive intervention could have higher benefit, compared with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot Walk (T25FW) The secondary aims of this study are: to determine whether fatigue, Quality of life, balance and locomotor function are improved by RAGT; to determine whether gait training influences markers of plasticity including clinical and circulating biomarkers to search for a possible correlation between clinical outcomes and clinical and circulating biomarkers
ClinicalTrials.gov, NCT02421731

Sites

  • Ferrara University HospitalFerrara, Italy