Robotic Gait Training in Multiple Sclerosis: a Randomized Clinical Trial Evaluating Virtual Reality Role

CompletedNot a drug-phase studyMS (type not specified)NCT02834533

What it found

No results found

We found no results in the registry or in papers.

This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Lokomat

What it measured

Main measures

  • Berg Balance Scale

    Up to 14 weeks

    Walking and mobility

Other measures (1)

  • Coping Orientation to Problem Experienced

    Up to 14 weeks

    Bladder, bowel and sexual function

Who could take part

MS (type not specified) · 30 to 65 · EDSS 3.5 to 6.0

Show the full criteria

Inclusion criteria

* Severe walking disability with Expanded Disability Status Score (EDSS) between 3.5 and 6.0 (Pyramidal subitem ≥3) * Montreal Cognitive Assessment score ≥24 * Absence of concomitant neurological or orthopedic conditions that may interfere with ambulation.

Exclusion criteria

* MS relapse during the three months prior to recruitment * Not well defined pharmacological therapy; presence of paroxysmal vertigo * Lower limb botulinum toxin injections within the previous 12 weeks * Cardiorespiratory instability high-risk of spontaneous fracture * Lower-limb skin lesions and phlebitis/thrombosis * More than 130kg body weight

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS). Method: A Randomized, double-blind, controlled clinical trial was carried out in forty patients with relapsing remitting MS. All patients were randomized into two groups. One group practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded neurologist and psychologist administered clinical and neuropsychological scales. All the clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative program.

Loading reviews and guidelines…

History

    1. Started

      Jan 2014

    2. Main results due

      Aug 2014

    3. Finished

      Jan 2015

    Assembled by software from public sources.