CompletedPhase 1Phase 2Progressive MSNCT00607126

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Lokomat

Compared with

  • resistive training

Results by group

Walking Speed as Assessed by 25' Timed Walk

at beginning,mid point, end and 12 weeks after intervention

GroupValueIntervalNumber analysed
Lokomat Training Using Body Weight Support on a Treadmill22.7 seconds17.6 (Standard Deviation)17
Resistive Training10.6 seconds4.9 (Standard Deviation)19
Lokomat Training Using Body Weight Support on a Treadmill23.9 seconds20.9 (Standard Deviation)17
Resistive Training9.8 seconds4.3 (Standard Deviation)19
Lokomat Training Using Body Weight Support on a Treadmill19.4 seconds15.2 (Standard Deviation)17
Resistive Training9.6 seconds3.7 (Standard Deviation)19
Lokomat Training Using Body Weight Support on a Treadmill21.7 seconds16.7 (Standard Deviation)17
Resistive Training10.5 seconds4.3 (Standard Deviation)19

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Lokomat Training Using Body Weight Support on a Treadmill170 (0.0%)
Resistive Training190 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Walking Speed as Assessed by 25' Timed Walk

    at beginning,mid point, end and 12 weeks after intervention

    Walking and mobility

Other measures (3)

  • Distance

    baseline, mid point, end and 12 weeks after training

    Walking and mobility
  • Fatigue

    baseline, mid, completetion, 3 months post

    Thinking and memoryFatigue
  • PASAT

    baseline, mid, completion, 3 months post training

    Thinking and memory

Who could take part

Progressive MS · 18 to 65

Inclusion Criteria: * Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device Exclusion Criteria: * Ataxia * Unable to ambulate * Within 3 months of exacerbation

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

About this trial

In the sponsor's words

Locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity. It has been reported to improve walking in patients with stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either locomotor training or an standard resistive exercise intervention.The locomotor training will be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a treadmill while they are suspended in a harness.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jul 2006

    2. Main results due

      Aug 2009

    3. Finished

      Aug 2009

    4. Results posted

      Aug 2016

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