An interventional study of Treadmill and Resistance in Rehabilitation and Multiple Sclerosis, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-01.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
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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 12th largest by enrollment of the 21 interventional ones that give a count, is the only one that started in 2013, is one of 20 with no phase, and was the 8th registered.
3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.
Browse Multiple Sclerosis studies →7 of the 25 studies in Multiple Sclerosis by Fondazione Don Carlo Gnocchi Onlus are open now, in 1 country. Recruiting first, the newest first:
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 25–85
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–85
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–60 · Healthy volunteers
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18+
Fondazione Don Carlo Gnocchi Onlus · Sites in Italy
Ages 18–70
By country, each count listing its studies:
Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (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.
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25 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2013.
This study's enrollment of 42 is below the median of 50 across 2,205 interventional studies indexed under Multiple Sclerosis.
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.
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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 |
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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.
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The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative multimodal training protocol carried out on treadmill on walking efficacy, mobility, balance, executive function, fatigue and health-related quality of life in a sample of persons with moderate to severe MS deficit of mobility compared to a control group that received a strengthening program of similar intensity.
Persons with multiple sclerosis can have various deficits, affecting many aspects of physical and cognitive functioning often leading to low levels of physical activity in daily life. These include poor endurance, muscle weakness, incoordination and poor balance and cognitive deficits that can all lead to persistent mobility difficulties in daily life.
Given the importance of exercise and physical activity for persons with multiple sclerosis that are already moderately to severely hampered by their locomotor ability and balance, the setting up of intense functional mobility training that targets the main deficits, in adjunction to a clinical rehabilitation usual care and under close supervision, may be a viable way of increasing the level of physiological health and give a basis for the persons to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking has several benefits for mobility rehabilitation. First, it is a everyday task, walking. Second it lends itself well to a dual task paradigm where other aspects of mobility, such as equilibrium and cognitive factors can be addressed during walking. Third, even persons with severe walking limitations can train walking at various speeds when on treadmill, holding onto handrails and using safety harnesses that minimize the possibility of adverse events during training. Further, the treadmill paradigm lends itself well to training with progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an aerobic component to improve cardiorespiratory fitness. All of which should lead to improved submaximal exercise tolerance and endurance, more functional mobility and consequently increased ability to carry out activities of daily living.
Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the beginning of the study.
The study design was a two arm randomized 2:1 controlled trial (see study flow chart in Figure 1).
The participants were assessed before and after the rehabilitation period by researchers blinded to group assignment.
Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times per week by experienced physical therapists trained for the study. All participants also followed their usual rehabilitation care protocols as planned.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the experimental group received supervised treadmill training
Behavioral: Treadmill
Participants in the control group were treated with Resistance exercises.
Behavioral: Resistance
Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.
Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise
Two minute walking test
The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.
Time frame: Two minutes
Timed up and go test
The Timed Up \& Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.
Time frame: 1 minute
The Frontal Assessment Battery
The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.
Time frame: 10 minutes
Ten meter walking test
The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
Time frame: 2 minutes
The Berg Balance Scale
The Berg Balance Scale (BBS) is a 14-item scale widely used to assess balance disorders in PwMS. BBS provides information about patient's balance-related abilities.
Time frame: 15 minutes
Dynamic Gait Index
The Dynamic Gait Index (DGI) measures gait function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects, and going upstairs.
Time frame: 15 minutes
The Short Form-12 questionnaire (SF-12)
The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.
Time frame: 10 minutes
Plan to share: Undecided — Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data
No publications or documents are linked to this record.
Ran from Jan 2013 to primary completion in May 2015, 28 months.
Of 849 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 9 and three quarters within 43. This study's 28 months is above that.
Counting every sponsor, half of 871 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 completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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