Robot-assisted Gait Training in Patients Affected by Multiple Sclerosis: Rehabilitative Efficacy Evaluation and Comparison With Traditional Methods

Status unknownNot a drug-phase studyMS (type not specified)NCT02291107

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 (Hocoma, Zurich, Switzerland)

Compared with

  • Conventional Physiotherapy

What it measured

Main measures

  • Timed 25 Foot Walk (25FW)

    5 weeks

    Disability progressionWalking and mobility

Other measures (13)

  • Timed 10 meter walking test (TWT)

    5 weeks

    Walking and mobility
  • 6 minute walking test (6MWT)

    5 weeks

    Walking and mobility
  • Tinetti Test (TT)

    5 weeks

    Walking and mobility
  • Functional Ambulation Categories (FAC)

    5 weeks

  • Modified Ashworth scale for lower limbs

    5 weeks

    Spasticity
  • Modified Motricity Index for lower limbs

    5 weeks

    Physical function
  • Knee extensor strength (KES)

    5 weeks

    Physical function
  • Double Time Support (DST)

    5 weeks

    Walking and mobility
  • Step Length Ratio (SLR)

    5 weeks

    Walking and mobility
  • Expanded Disability Status Scale (EDSS)

    5 weeks

    Disability progression

Who could take part

MS (type not specified) · EDSS 3.5 to 7

Show the full criteria

Inclusion criteria

* diagnosis of multiple sclerosis according to the McDonald's Criteria in stable phase of disease for at least 3 months. * ability to walk 25 foot without assistance * EDSS score between 3.5 and 7

Exclusion criteria

* exacerbations of the disease in the last 3 months * deficits of somatic sensation involving the legs * other neurological, orthopedic or cardiovascular co-morbility * severe posture abnormalities * severe-moderate cognitive impairment (Mini Mental State ≤ 21) * body weight greater than 135 kg; * height more than 200 cm; * limb-length discrepancy greater than 2 cm; * presence of skin lesions on the trunk, pelvis and lower limbs that could interfere with the placement of the electrodes and straps anchoring the Lokomat.

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

About this trial

In the sponsor's words

In Multiple Sclerosis (MS) gait disorders represent one of the most disabling aspect that strongly influence patient quality of life. The improvement of walking ability is a primary goal for rehabilitation treatment. Current promising rehabilitative approaches for neurological disorders are based on the concept of the task-specific repetitive training. Hence, the interest in automated robotic devices that allow this typology of treatment for gait training. However, studies on the effectiveness of such methodologies are still poorly numerous in terms of functional improvement in MS patients. The aim of this controlled cross-over study is to evaluate the effectiveness of a Lokomat gait training in patients affected by Multiple Sclerosis in comparison to a ground conventional gait training.

Papers

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History

    1. Started

      Jun 2014

    2. Main results due

      Dec 2015

    3. Finished

      Jun 2016

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