Effects of GE-O System on Gait Impairments in Multiple Sclerosis Subje

The Effects of an Innovative Gait Robot for the Repetitive Practice of Floor Walking and Stair Climbing up and Down in Patients Suffered From Multiple Sclerosis: a Randomized Control Trial

Status unknownNot a drug-phase studyMS (type not specified)NCT02459821

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • GE-O SYSTEM

Compared with

  • Conventional training

What it measured

Main measures

  • 6-Minute Walking Test (meters)

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

    Walking and mobility

Other measures (8)

  • 10-Metre Walking Test (seconds)

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

    Walking and mobility

  • Berg Balance Scale

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

    Walking and mobility

  • Activities-specific Balance Confidence Scale

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

    Walking and mobility

  • Fatigue Severity Scale

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

    Fatigue

  • Stair Climbing Test (seconds)

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

  • Multiple Sclerosis Quality Of Life-54

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

    Quality of life (reported by participants)

  • Gait Analysis

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

    Walking and mobility

  • Stabilometric assessment

    All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

Who could take part

MS (type not specified) · 18 to 75 · EDSS 3 to 6.5

Show the full criteria

Inclusion criteria

* Expanded Disability Status Scale (EDSS) between 3 and 6.5; * Mini Mental Examination State >24; * Absence of cognitive impairment; * Age \<75 years; * Absence of heart failure; * Ability to sit without trunk support; * Ability to stand for at least 10 seconds with support; * Absence of concurrent neurological or orthopaedic diseases that interfere with deambulation;

Exclusion criteria

* Those patients with disease reccurence that worsens significantly during the 8 weeks before recruitment; * changes in pharmacological therapy that could modified disease course in the previous three months; * changes in pharmacological therapy for fatigue treatment in the previous three months; * performance of any type of rehabilitation treatment in the month prior to recruitment.

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 the most common non-traumatic cause of neurologic disability in young adults,affecting mobility and ambulation in the majority of patients. At least 50% of individuals with MS will require an assistive device to ambulate within ten years of diagnosis. Impaired mobility is one of the top three factors associated with inability to continue working. In addition,impaired mobility and the inability to walk functionally translate into significant costs for personal assistance, medical complications, and lost wages because of unemployment. Clearly,maximizing the ability to ambulate, as well as perform safe and effective transfers,is a fundamental goal in the management of individuals with MS. None of the currently available MS disease-modifying medications have been shown to stop or reverse gait disability. Repetitive locomotor training is an innovative approach in gait disturbances in patients with MS. Only scant data on this issue is available and all the studies have been performed by means of treadmill training or robot assisted gait training (RAGT) approaches. The recent introduction of a robotic device to gait rehabilitation showed a significant improvement in gait ability in patients with neurological disease due to the possibility of being trained under a graduated body weight support condition and being being guided to reproduce a physiologic gait pattern. In 2010 a novel device called GE-O System was developed. It enables patients to repetitively practice walking on the floor and also climb up and down stairs. To date, the effectiveness of this novel device has not yet been evaluated in patients with MS. The aims of the study are as follows: to evaluate the effectiveness of a specific gait training program consisting of the GE-O System in patients with MS in improving balance and walking ability,reducing fatigue,the frequency of falls,the fear of falling and disability in activities of daily living and finally,improving quality of life.

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History

    1. Started

      May 2015

    2. Main results due

      Sept 2016

    3. Finished

      Dec 2016

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