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

NCT01040299 | Completed DMC

• 1 other identifier: GT-1-tDCS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis; Cerebrovascular Disorders

Keywords

GangTrainer; Gait Rehabilitation; Cerebrovascular Disorders; Robot assisted; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Motricity Index

  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 (10)

• Barthel Index

  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

• European Stroke Scale

  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

• Modified Ashworth Scale

  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

• Questionary of Ambulation

  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

• Rivermead Motor Assessment Score

  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

Study Arms (3)

GangTrainer and tDCS

EXPERIMENTAL

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

control group1

SHAM COMPARATOR

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

Device: control group1

control group2

ACTIVE COMPARATOR

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

Other: Control group2

Interventions

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.

GangTrainer and tDCS

control group1 DEVICE

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

Also known as: GangTrainerGT1

control group1

Control group2 OTHER

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

Also known as: convectional physiotherapy

control group2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Italy, Verona, 37134, Italy

Location

Related Publications (3)

• 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.

  PMID: 17473391 BACKGROUND

• 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.

  PMID: 17213237 RESULT

• 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.

  PMID: 18084173 RESULT

MeSH Terms

Conditions

Paresis; Cerebrovascular Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Nicola Smania Nicola Smania, Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 28, 2009
• First Posted: December 29, 2009
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

IT (1)