Robot-assisted Arm Training in Multiple Sclerosis

Effects of High-intensity Robot-assisted Training in Hand Function Recovery and ADL Independence in Individuals With Multiple Sclerosis: a Randomized Controlled Single-blinded Trial

CompletedNot a drug-phase studyMS (type not specified)NCT03561155

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

  • Robot assisted treatment (Amadeo®)

Compared with

  • Conventional treatment

What it measured

Main measures

  • Action Research Arm test

    Up to 6 weeks

    Arm and hand function

Other measures (10)

  • Fugl-Meyer Assessment Motor Scale - Arm Section

    Up to 6 weeks

  • Motor Activity Log

    Up to 6 weeks

    Arm and hand function

  • Tremor Severity Scale

    Up to 6 weeks

    Physical function

  • Nine Hole Peg Test

    Up to 6 weeks

    Arm and hand function

  • Motricity Index

    Up to 6 weeks

    Arm and hand functionPhysical function

  • Amadeo® hand muscle strength (Newton)

    Up to 6 weeks

    Physical function

  • Visual anolgue Scale for tiredness and fatigue

    Up to 6 weeks

    Fatigue

  • Multiple Sclerosis Quality of Life-54

    Up to 6 weeks

    Quality of life (reported by participants)

  • Assessment of Life Habits

    Up to 6 weeks

  • UL electromyographic analysis of muscle activation

    Up to 6 weeks

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

* Age: 18-65 years * EDSS score\<8 * Mini Mental State Evaluation (MMSE) score>24 * Ashworth Scale Score\<2 evaluated at the elbow, wrist and fingers * Nine Hole Peg Test (NHPT) score >30 sec.

Exclusion criteria

* Disease recurrence that worsened significantly during the 3 months prior to recruitment * Medical therapy not well defined * Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program * Severe visual dysfunction * Performance of any type of rehabilitation treatment in the month prior to recruitment * Other concomitant neurological or orthopaedic diseases involving the UL and interfering with their function

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

About this trial

In the sponsor's words

The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life. Effective arm-hand training programs are needed. Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke. Preliminary work in MS has focused on proximal sections of the arm. No study has evaluated the use of robotics for improving manual dexterity and their effects on cortical activity. The results of this research project could be relevant for the advancement of knowledge about UL functional recovery in individuals with MS and to determine the pattern of muscle activation underlying functional recovery.

Papers

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History

    1. Started

      Nov 2014

    2. Main results due

      Sept 2017

    3. Finished

      May 2018

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