An interventional study of Treadmill training in Multiple Sclerosis, sponsored by Fondazione Don Carlo Gnocchi Onlus. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
Among 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus — 7 open to participants now, 8 under way, none of them phase 3. Multiple Sclerosis · Fondazione Don Carlo Gnocchi Onlus.
Among the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus, this one is the 14th largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2018, is one of 20 with no phase, and was the 10th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →7 of the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus are open now, in 1 country. Each count lists the studies.
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →25 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2018.
Median enrollment 48 across the 21 interventional studies, 142 across the 4 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
1 of the studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05493514Fondazione Don Carlo Gnocchi OnlusClinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System | 2027-04-01 |
Among the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus, from their registry updates:
Nothing recorded among them since 2026-09-25.
The aim of the study is to set up a pilot study to investigate the effects of treadmill training in preventing the onset and worsening of walking impairments, balance deficits and fatigue.
As regards the of potential impact of exercises on functional decline at best of our knowledge no studies have been done on preventive interventions on walking, balance and fatigue disorders in early diagnosed PwMS. However, preliminary studies found that walking exercises can improve performances in PwMS with mild disability. van der Berg et al (van der Berg, 2006) investigated whether four weeks of aerobic treadmill training would improve mobility and fatigue in PwMS. They found that aerobic treadmill training is feasible and well tolerated and walking speed and endurance increased after training without changes in reported fatigue. In agreement with this study, Sabapathy et al (Sabapathy, 2011) reported improvements in mobility after endurance exercise training. Recent reviews (Dalgas, 2008 and Heine, 2015) and a recent paper by Sandroff et al (Sandroff, 2015) suggested that endurance training at low moderate intensity is well tolerated, has beneficial effects and reduces level of fatigue in MS patients having EDSS lower than 7.
Furthermore, the long-term effects of walking based aerobic endurance exercise on gait parameters were investigated by Wonnemberg et al (Wonnemberg, 2015). They found that step cadence decreased significantly and the step length increased significantly after 12 months suggesting that walking based aerobic endurance exercise may contribute to improved gait parameters in MS patients.
Walking exercises can be performed using treadmills. A Systematic review by Swinnen et al. (Swinnen, 2012) addresses the effect of different treadmill training (TT) modalities in PwMS. It showed that treadmill training improves walking skills and distance. In addition, Braendvik et al (Braendvik, 2015) revealed that TT was superior progressive strength training in improving walking in mild to moderate PwMS. Peruzzi et al. (Peruzzi, 2016) found similar results using Virtual Reality-based TT in PwMS with mild to moderate disability. After training, gait speed, stride length and the ability in negotiating obstacles were improved. Finally Gervasoni et al (Gervasoni, 2013) showed that 3-week of treadmill training reduced fatigue in PwMS.
The Hypothesis to be tested is that treadmill training can reduce subtle balance and gait impairments decreasing the impact of MS on the activities of daily living and, thereby, favorably impact on the disease progression.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects continue participating in their normal daily and physical activities.
16 sessions (2 sessions/week for 8 weeks) of treadmill training as recommended in a review on this subject (Langeskov-Christensen, 2015) aimed at the reduction/stabilization of gait and balance disturbances.
Other: Treadmill training
Tailored treatment comprising of: 1) aerobic exercises with the aim of increasing fitness 2) task-oriented balance exercises on the treadmill to improve balance and 3) cognitive behavioral interventions to improve balance and gait during dual task activities.In accordance with the literature (Langeskov-Christensen, 2015, Latimer-Cheung, 2013) the treadmill training will be carried out without body weight support, but the participants will be allowed to use the handrails for balance support if needed. The training consists of three different walking sessions, each lasting for 10 minutes: 1) preferred walking speed at an increased slope; 2) walking doing dynamic balance exercises (for example walking with feet in tandem) 3) fast gait speed defined as a 10% increase in walking speed relative to preferred speed with dual task exercises. During the 8-week intervention, walking speed in session 3 will be gradually increased with 10% to 40% of preferred speed.
Change in Six Minutes Walking Test
Tool used to assess walking endurance
Time frame: Change from Baseline 6 minutes walking test scores at 8 weeks
Change in Instrumented variables
Gait asymmetry, Root mean squared of trunk Jerk and gait regularity on the vertical and medio-lateral plane estimated by autocorrelation coefficients (Moe-Nilssen, 2004) during the Six minutes walking test.
Time frame: Change from Baseline scores at 8 weeks
the Twelve-Item Walking Scale
Patient reported outcome about walking
Time frame: Change from Baseline Twelve-Item Walking Scale scores at 8 weeks
the Twentyfive-foot walking test
Tool used to assess walking velocity
Time frame: Change from Baseline Twentyfive-foot walking test scores at 8 weeks
The Fatigue Severity Scale
Patient reported outcome about fatigue
Time frame: Change from Baseline Fatigue Severity Scale scores at 8 weeks
the Nine hole peg test
Tool used to assess manual dexterity
Time frame: Change from Baseline Nine Hole Peg test scores at 8 weeks
Started May 2018 (actual). Primary completion is estimated for Dec 2019, 19 months after the start.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 19 months is below that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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