Traditional Versus Progressive Robot-assisted Gait Training in People

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

Status unknownNot a drug-phase studyProgressive MSNCT06381440

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Lokomat device (Hocoma AG, Volketswil, Switzerland).

Compared with

  • Conventional walking training

What it measured

Main measures

  • Walking function

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Walking and mobility

Other measures (17)

  • Mobility

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Walking and mobility

  • Walking endurance

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Walking and mobility

  • Balance

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Walking and mobility

  • Spasticity

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Spasticity

  • Perceived quality of life

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Physical functionQuality of life (reported by participants)

  • Perceived walking ability

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    FatigueWalking and mobility

  • Fatigue

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Fatigue

  • Anxiety

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Mood and sleep

  • Depression

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Mood and sleep

  • Kinesiophobia

    Score changes before (T0) and after (T1) the twelve sessions of treatment and at 3-months follow-up (T2).

    Physical function

Who could take part

Progressive MS · 18 to 65 · EDSS 6 to 7

Show the full criteria

Inclusion criteria

* Diagnosis of MS (primary or secondary progressive) without relapses in the preceding 3 months * Disability rate defined by Expanded Disability Status Scale (EDSS) score from 6 to 7 * Ability to perform the Timed 25-Foot Walk (T25-FW) test * Mini-Mental Status Examination score ≥ 24/30

Exclusion criteria

* Other (neurological) conditions that may affect motor function * Medical conditions might interfere with the ability to complete the study protocol safely * Presence of spasticity with a Modified Ashworth Scale (MAS) score > 3 or retractions limiting the range of motion of the hip, knee or ankle * MS relapses or medication changes or any other confounding factors during the study period * Rehabilitation treatment or botulinum toxin injection in the 3 months preceding the start of the study

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

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT.

Papers

Loading reviews and guidelines…

History

    1. Started

      Nov 2023

    2. Main results due

      Nov 2024

    3. Finished

      Nov 2024

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