Multiple Sclerosis Clinical Trial
Official title:
Effectiveness of Robot-assisted Gait Training Versus Conventional Therapy on Mobility in Severely Disabled Multiple Sclerosis Patients
Verified date | February 2017 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 72 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - severe gait impairments defined as EDSS 6-7 - lack of EDSS worsening in the last 3 months Exclusion Criteria: - neurologic conditions in addition to MS that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol - impaired cognitive functioning: score less than 24 on the Mini Mental State Examination - spasticity (Ashworth scale >3) or contractures that may limit range of motion or function - changes in disease modifying drug therapy or in any other confounding factor during the study. |
Country | Name | City | State |
---|---|---|---|
Italy | Ferrara University Hospital | Ferrara |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara | Regione Emilia-Romagna, Università degli Studi di Ferrara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Timed 25 Foot Walk | The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet (7.62m) as quickly as possible, but safely, using the prescribed assistive devices. | weeks: 0,2,4,16 | |
Secondary | Six-Minute Walking Test | The walking endurance is measured with the Six-Minute Walking Test. This test, first validated in subjects with cardio-pulmonary problems, is considered a feasible, reproducible and reliable measure also in MS. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes without encouragement, with the possibility to slow down and rest if necessary. | weeks: 0,2,4,16 | |
Secondary | Berg Balance Scale | This is an assessment scale of ability to maintain balance, or statically or while performing functional movement, including 14 observable tasks common to everyday life measured on a 5 point ordinal scale. | weeks: 0,2,4,16 | |
Secondary | Up and Go Test | Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch. | weeks: 0,2,4,16 | |
Secondary | Fatigue Severity Scale | The Fatigue Severity Scale is a method of evaluating fatigue in MS and other conditions. Essentially, the Fatigue Severity Scale consists of answering a short questionnaire that requires the subject to to read each statement and rate his or her own level of fatigue from 1 to 7, depending on how appropriate they felt the statement applied to them over the preceding week. | weeks: 0,2,4,16 | |
Secondary | Modified Ashworth Scale | This is a 6-point measure of spasticity. We will assess the spasticity at the hip, knee and ankle (flexors and extensors muscles). | weeks: 0,2,4,16 | |
Secondary | Short-Form 36 | This is an assessment tool of quality of life. | weeks: 0,2,4,16 | |
Secondary | Haemodynamic measurements | Doppler venous flow volume measurement, with evaluation of the thoracic pump; postural control of cerebral venous return assessed by plethysmography5; venous haemodynamics insufficiency severity score will be also evaluated and calculated. | weeks: 0,2,4,16 | |
Secondary | Metabolic measurements by Near infrared spectroscopy | Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks. Patients will walk on the treadmill at a speed of 0.2 km/h assisted by personnel and with partial body weight support, performing 4 short tasks (30 seconds of walking) alternated by rest periods (30 seconds). | weeks: 0,2,4,16 | |
Secondary | Circulating biomarkers | blood biomarker levels modifications | weeks: 0,2,4,16 |
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