Robot-based Assessment and Therapy in the Treatment of Upper Limb Impairment in Multiple Sclerosis: a Multi-center, Randomised Controlled Trial

CompletedNot a drug-phase studyMS (type not specified)NCT02711566

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

  • Physioassistant: Haptic training

Compared with

  • Physioassistant: Sensorimotor training

What it measured

Main measures

  • Change of the 9 Hole Peg Test score

    baseline and 4 weeks and baseline and 16 weeks

    Disability progression

Other measures (3)

  • Treatment change in percentage of responders at 9 Hole Peg Test score

    baseline and 4 weeks and baseline and 16 weeks

    Disability progression
  • Absolute change of exercise performance

    baseline and 4 weeks and baseline and 16 weeks

    Physical function
  • Absolute change of task difficulty

    baseline and 4 weeks and baseline and 16 weeks

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* definite Multiple sclerosis, stable phase of the disease * no relapses or worsening >1 in the Expanded Disability Status Scale in the last three months, * Expanded Disability Status Scale\<7.5, * Ashworth score at the upper limb lower than 2, * Nine-Hole Peg Test between 30 s and 180 s

Exclusion criteria

* previous treatment with robot therapy, * presence of severe nystagmus, * visual acuity less than 4/10 * major orthopaedic or other disorders interfering with the protocol

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

About this trial

In the sponsor's words

Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke survivors. Robots can be programmed to interact with patients by guiding their movements, by monitoring their performance and by quantifying the type and degree of their impairment. A distinctive element of multiple sclerosis is the involvement of a variety of functional systems, in a way that is highly subject-specific. This requires a personalization of treatment, and continuous adaptation to changes in condition. This points to a need for integrating patient assessment, definition of rehabilitation protocols, their administration and the assessment of their outcome. The goal of this study is to assess, in persons with MS, the efficacy of a type of robot-assisted training that was specifically designed to counteract incoordination and muscle weakness (typical of MS), tailored to individual type and degree of impairment, when compared to simple movement training.

Papers

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History

    1. Started

      Jan 2010

    2. Main results due

      Jul 2011

    3. Finished

      Dec 2011

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