Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke (GT-1-tDCS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicola Smania, MD, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01040299
First received: December 28, 2009
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Hemiparesis
Cerebrovascular Disorders
Device: GangTrainer and tDCS
Device: control group1
Other: Control group2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GangTrainer and tDCS
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.
Device: GangTrainer and tDCS
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.
Other Name: GangTrainer and tDCS
Sham Comparator: control group1
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
Device: control group1
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
Other Name: GangTrainerGT1
Active Comparator: control group2
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Other: Control group2
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Other Name: convectional physiotherapy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040299

Locations
Italy
Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Verona, Italy, Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Investigators
Principal Investigator: Nicola Smania Nicola Smania, Doctor
  More Information

Publications:
Responsible Party: Nicola Smania, MD, professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT01040299     History of Changes
Other Study ID Numbers: GT-1-tDCS
Study First Received: December 28, 2009
Last Updated: March 23, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Universita di Verona:
GangTrainer
Gait Rehabilitation
Cerebrovascular Disorders
Robot assisted
Transcranial direct current stimulation

Additional relevant MeSH terms:
Cerebrovascular Disorders
Paresis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014