Sensor-Based Analysis And rehabiLitation of bAlance in Neurological Diseases: a multiCentric randomizEd Clinical Trial

Status unknownNot a drug-phase studyRelapsing and progressiveNCT04874051

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Experimental Group

Compared with

  • Control Group

What it measured

Main measures

  • Berg Balance Scale (BBS)

    Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)

    Walking and mobility

Other measures (9)

  • Number of falls during the last year

    Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter)

    Walking and mobility
  • Functional Ambulation Classification (FAC)

    Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter)

  • Activities specific-Balance Confidence scale (ABC)

    Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter)

    Walking and mobility
  • Functional Independence Measure (FIM)

    Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter)

  • Barthel Index (BI)

    Change from baseline Barthel Index at the end of the therapy (three weeks thereafter)

  • National Institution of Health Stroke Scale (NIHSS)

    Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter)

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter)

  • Hoehn & Yahr Scale (H&Y)

    Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter)

  • Kurtzke Extended Disability Status Scale (EDSS)

    Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter)

    Disability progression

Who could take part

Relapsing and progressive · 18 to 90

Show the full criteria

Inclusion criteria

Common criteria: * Berg Balance Scale \< 50/56; * Ability to maintain the standing position with o without one support for 1 minute; * Functional Independence measure \< 100/126; * Barthel Index \< 80/100. Stroke: * Single ischemic stroke; * Lesion occured after 2 and within 18 months; * National Institute of Health Stroke Scale ≤ 14. Parkinson: * 1.5 \< Hoehn \& Yahr \< 3; * Subitem "freezing when walking"of the UPDRS ≤ 2. Multiple Sclerosis: * Relapsing remitting or secondary progressive Multiple Sclerosis; * Expanded Disability Status Scale ≤ 6.5.

Exclusion criteria

* Untreated epilepsy; * Major depressive disorder; * Fractures; * Dementia; * Ideomotor Apraxia; * Neglect; * Severe impairment of verbal comprehension; * Severe acoustic and visual disorders.

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

About this trial

In the sponsor's words

Balance impairment is one of the most common disorders due to a neurological diseases. Sensor-based technologies may be useful for falls prevention and balance recovery during patients hospitalization. OAK Elderly Care System (Khymeia Group, Noventa Padovana, Italy) allows the assessment of fall risk, the centre of pressure and the execution of balance exercises in a virtual environment.

Papers

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    History

      1. Started

        Sept 2019

      2. Main results due

        Dec 2023

      3. Finished

        Dec 2023

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