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Completed

NCT Number: NCT01040299

Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke

Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective, but nevertheless only a few patients could use their affect lower limb functionally in daily life on deambulation after robot training. Therefore the present study intends to combine both approaches, tDCS + GT, apply at the same time every day for two weeks in order to improve the effectiveness of GangTrainer therapy in the gait rehabilitation.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Italy, Verona, 37134, Italy

About this study

Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective. Therefore the present study intends to combine both approaches, tDCS + GT, apply at the same time every day for two weeks in order to improve the effectiveness of GangTrainer therapy in the gait rehabilitation. The rehabilitation programme are compose 3 kinds of locomotor training interventions (experimental group, control group 1 and control group 2).

During intervention experimental group, patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital. The anodal stimulation is expected to facilitate the activity of the lower limb motor area side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation, and the control group 2 receive a total of 10 treatments with convectional physiotherapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • European Stroke scale between 75-85
  • First time supratentorial, ischaemic or hemorrhagic stroke.
  • Diagnosis of ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography > 6 months after the onset of stroke.
  • Age < 80 years.
  • Ability to stand upright, supported or unsupported, for 1 minute.
  • Patients with ischaemic or haemorrhagic stroke.
  • In-patient participating in a comprehensive rehabilitation programme.
  • patients written informed consent of participation in the study approved by the local ethical committee.
  • absence of cardiac, psychological and orthopedic conditions that might interfere with the result.

Exclusion criteria

  • Preceding epileptic fits.
  • an EEG suspect of elevated cortical excitability.
  • a sensitive scalp skin.
  • severe cognitive impairment.
  • metallic implants within the brain.
  • previous brain neurosurgery.
  • medications altering the level of cortical excitability
  • medications with a presumed positive or negative effect on brain plasticity.

Treatment and study plan

GangTrainer and tDCS

Device

The experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital.

control group1

Device

The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.

Other names: GangTrainerGT1

Control group2

Other

The control group 2 receive a total of 10 treatments with convectional physiotherapy.

Other names: convectional physiotherapy

Primary outcomes

  1. Motricity Index

    Time frame: 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.

Secondary outcomes

  1. Barthel Index

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  2. European Stroke Scale

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  3. Modified Ashworth Scale

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  4. Questionary of Ambulation

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  5. Rivermead Motor Assessment Score

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  6. Functional Ambulation Category

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  7. Ten Meters Walking Test

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  8. Six Minutes Walking Test

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  9. Spatia-temporal Gait analysis

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

  10. Motricity Index

    Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial

Acronym: GT-1-tDCS

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 29, 2009
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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