Evidence map›Paper›PMID 38779575›Full record

ArticleBMJ open sport & exercise medicine2024

Traditional versus progressive robot-assisted gait training in people with multiple sclerosis and severe gait disability: study protocol for the PROGR-EX randomised controlled trial.

Andrea Baroni, Nicola Lamberti, Marialuisa Gandolfi, Michela Rimondini, Valeria Bertagnolo, Silvia Grassilli, Luigi Zerbinati, Fabio Manfredini, Sofia Straudi

Registry-linked trialAbstract read
In one paragraph

Article in BMJ open sport & exercise medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06381440 (Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06381440 naunknown statusnot on this map

Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability: Study Protocol for a the PROGR-EX Randomized-controlled Trial

TypeinterventionalSponsorUniversity Hospital of FerraraRan2023 to 2024Enrolled24ConditionsMultiple SclerosisArmsLokomat device (Hocoma AG, Volketswil, Switzerland)., Conventional walking training
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Andrea BaroniDepartment of Neuroscience and Rehabilitation, Ferrara University, Ferrara, Italy.ORCID 0000-0002-8681-3090
Nicola LambertiDepartment of Neuroscience and Rehabilitation, Ferrara University, Ferrara, Italy.
Marialuisa GandolfiDepartment of Neurosciences, Biomedicine and Movement Sciences, Verona University, Verona, Italy.
Michela RimondiniDepartment of Neurosciences, Biomedicine and Movement Sciences, Verona University, Verona, Italy.
Valeria BertagnoloDepartment of Translational Medicine, Ferrara University, Ferrara, Italy.
Silvia GrassilliDepartment of Environment and Prevention Sciences, Ferrara University, Ferrara, Italy.
Luigi ZerbinatiDepartment of Neuroscience and Rehabilitation, Ferrara University, Ferrara, Italy.
Fabio ManfrediniDepartment of Neuroscience and Rehabilitation, Ferrara University, Ferrara, Italy.
Sofia StraudiDepartment of Neuroscience and Rehabilitation, Ferrara University, Ferrara, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Gait disorders are the most frequent symptoms associated to multiple sclerosis (MS). Robot-assisted gait training (RAGT) in people with MS (PwMS) has been proposed as a possible effective treatment option for severe motor disability without significant superiority when compared to intensive overground gait training (OGT). Furthermore, RAGT at high intensity may enhance fatigue and spasticity. This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT in PwMS and moderate to severe walking impairment. 24 PwMS will be recruited and assigned to one of the three treatment groups: low-intensity RAGT at progressively increasing intensity, conventional RAGT and OGT. All participants will receive 3-weekly treatment sessions of 3 hours each for 4 weeks. In the first 2 hours of treatment, all participants will receive a rehabilitation programme based on stretching exercises, muscle strengthening and educational interventions. During the last hour, subjects will undergo specific gait training according to the assignment group. Outcomes will be assessed before and after treatment and at 3-month follow-up. The primary outcome is walking speed. Secondary outcomes include mobility and balance, psychological measures, muscle oxygen consumption, electrical and haemodynamic brain activity, urinary biomarkers, usability, and acceptability of robotic devices for motor rehabilitation. The results of this study will provide a safe, affordable and non-operator-dependent, intervention for PwMS. Results in terms of functional, psychological, neurophysiological and biological outcomes will confirm our hypothesis. The study's trial registration number: NCT06381440.

Indexed as

ExerciseNeurological rehabilitationRehabilitationTrainingWalking

Identifiers

PMID38779575
PMCPMC11110587

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.