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

Primary Purpose

Hemiparesis, Cerebrovascular Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
GangTrainer and tDCS
control group1
Control group2
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis focused on measuring GangTrainer, Gait Rehabilitation, Cerebrovascular Disorders, Robot assisted, Transcranial direct current stimulation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

GangTrainer and tDCS

control group1

control group2

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Motricity Index

Secondary Outcome Measures

Barthel Index
European Stroke Scale
Modified Ashworth Scale
Questionary of Ambulation
Rivermead Motor Assessment Score
Functional Ambulation Category
Ten Meters Walking Test
Six Minutes Walking Test
Spatia-temporal Gait analysis
Motricity Index

Full Information

First Posted
December 28, 2009
Last Updated
March 23, 2012
Sponsor
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT01040299
Brief Title
Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke
Acronym
GT-1-tDCS
Official Title
Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Cerebrovascular Disorders
Keywords
GangTrainer, Gait Rehabilitation, Cerebrovascular Disorders, Robot assisted, Transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GangTrainer and tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
control group1
Arm Type
Sham Comparator
Arm Description
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
Arm Title
control group2
Arm Type
Active Comparator
Arm Description
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Intervention Type
Device
Intervention Name(s)
GangTrainer and tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
control group1
Other Intervention Name(s)
GangTrainerGT1
Intervention Description
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
Intervention Type
Other
Intervention Name(s)
Control group2
Other Intervention Name(s)
convectional physiotherapy
Intervention Description
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Smania Nicola Smania, Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
City
Verona
State/Province
Italy, Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17473391
Citation
Hesse S, Werner C, Schonhardt EM, Bardeleben A, Jenrich W, Kirker SG. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: a pilot study. Restor Neurol Neurosci. 2007;25(1):9-15.
Results Reference
background
PubMed Identifier
17213237
Citation
Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
Results Reference
result
PubMed Identifier
18084173
Citation
Dias D, Lains J, Pereira A, Nunes R, Caldas J, Amaral C, Pires S, Costa A, Alves P, Moreira M, Garrido N, Loureiro L. Can we improve gait skills in chronic hemiplegics? A randomised control trial with gait trainer. Eura Medicophys. 2007 Dec;43(4):499-504.
Results Reference
result

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

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