Robot-assisted Gait Training on Mobility in Severely Disabled Multiple
Effectiveness of Robot-assisted Gait Training Versus Conventional Therapy on Mobility in Severely Disabled Multiple Sclerosis Patients
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Robot-assisted gait training
Compared with
- Conventional therapy
What it measured
Main measures
Timed 25 Foot Walk
weeks: 0,2,4,16
Disability progressionWalking and mobility
Other measures (9)
Six-Minute Walking Test
weeks: 0,2,4,16
Walking and mobilityBerg Balance Scale
weeks: 0,2,4,16
Walking and mobilityUp and Go Test
weeks: 0,2,4,16
Walking and mobilityFatigue Severity Scale
weeks: 0,2,4,16
FatigueModified Ashworth Scale
weeks: 0,2,4,16
SpasticityShort-Form 36
weeks: 0,2,4,16
Quality of life (reported by participants)Haemodynamic measurements
weeks: 0,2,4,16
Metabolic measurements by Near infrared spectroscopy
weeks: 0,2,4,16
Walking and mobilityCirculating biomarkers
weeks: 0,2,4,16
Blood or spinal fluid markers
Who could take part
MS (type not specified) · 18 to 65 · EDSS 6 to 7
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's 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
Papers
Results
The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial.Trials · 2017
Results
Manfredini F, Straudi S, Lamberti N, Patergnani S, Tisato V, Secchiero P, Bernardi F, Ziliotto N, Marchetti G, Basaglia N, Bonora M, Pinton P. Rehabilitation Improves Mitochondrial Energetics in Progressive Multiple Sclerosis: The Significant Role of Robot-Assisted Gait Training and of the Personalized Intensity. Diagnostics (Basel). 2020 Oct 17;10(10):834. doi: 10.3390/diagnostics10100834.Results
Straudi S, Manfredini F, Lamberti N, Martinuzzi C, Maietti E, Basaglia N. Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial. Mult Scler. 2020 May;26(6):716-724. doi: 10.1177/1352458519833901. Epub 2019 Mar 4.
Loading reviews and guidelines…
History
Started
Feb 2014
Main results due
Feb 2018
Finished
Feb 2018