- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01040299
Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke (GT-1-tDCS)
Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Italy, Verona
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Verona, Italy, Verona, Italien, 37134
- Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
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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.
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Schein-Komparator: control group1
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
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The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
Andere Namen:
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Aktiver Komparator: control group2
The control group 2 receive a total of 10 treatments with convectional physiotherapy.
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The control group 2 receive a total of 10 treatments with convectional physiotherapy.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Motricity Index
Zeitfenster: 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.
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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.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Barthel Index
Zeitfenster: 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
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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
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European Stroke Scale
Zeitfenster: 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
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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
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Modified Ashworth Scale
Zeitfenster: 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
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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
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Questionary of Ambulation
Zeitfenster: 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
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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
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Rivermead Motor Assessment Score
Zeitfenster: 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
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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
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Functional Ambulation Category
Zeitfenster: 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
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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
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Ten Meters Walking Test
Zeitfenster: 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
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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
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Six Minutes Walking Test
Zeitfenster: 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
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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
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Spatia-temporal Gait analysis
Zeitfenster: 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
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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
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Motricity Index
Zeitfenster: 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
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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
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nicola Smania Nicola Smania, Doctor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GT-1-tDCS
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