Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients
14. März 2019 aktualisiert von: Yonsei University
Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial
This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.
- Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
- Subjects : total 99 patients with stroke whose upper limb functions are impaired
- Intervention : 4 weeks of therapy (5 days per week)
- Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
- Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
108
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Seoul, Korea, Republik von, 03722
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Upper FMA 7-38
- Hemiplegic patients within 6months after stroke onset
- male or female, 20 years older
Exclusion Criteria:
- Patients with cognitive impairment who are unable to comply with protocol-required procedure
- Quadriplegic or double hemiplegic patients
- Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
- Patients with lower motor neuron disease
- Patients who cannot perform rTMS
- Pregnant woman
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Robot and rTMS
Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
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The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain. The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Andere Namen:
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Experimental: Robot
Robot-Assisted upper arm training group(intervention group2)
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The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively.
This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software.
The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks.
And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Andere Namen:
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Aktiver Komparator: Conventional
Conventional training group(control group)
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The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS.
And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Fugl-Meyer Assessment (FMA)
Zeitfenster: 1 minute before the first intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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1 minute before the first intervention
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Fugl-Meyer Assessment (FMA)
Zeitfenster: 2 weeks after the first intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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2 weeks after the first intervention
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Fugl-Meyer Assessment (FMA)
Zeitfenster: 4 weeks after the first intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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4 weeks after the first intervention
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Fugl-Meyer Assessment (FMA)
Zeitfenster: 4 weeks after the final intervention
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The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
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4 weeks after the final intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Wolf motor function test
Zeitfenster: 1 minute before the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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1 minute before the first intervention
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Wolf motor function test
Zeitfenster: 2 weeks after the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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2 weeks after the first intervention
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Wolf motor function test
Zeitfenster: 4 weeks after the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
|
4 weeks after the first intervention
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Wolf motor function test
Zeitfenster: 4 weeks after the final intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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4 weeks after the final intervention
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Manual Function test
Zeitfenster: 1 minute before the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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1 minute before the first intervention
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Manual Function test
Zeitfenster: 2 weeks after the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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2 weeks after the first intervention
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Manual Function test
Zeitfenster: 4 weeks after the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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4 weeks after the first intervention
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Manual Function test
Zeitfenster: 4 weeks after the final intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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4 weeks after the final intervention
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Kinematic data of computerized 3D motion analysis
Zeitfenster: 1 minute before the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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1 minute before the first intervention
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Kinematic data of computerized 3D motion analysis
Zeitfenster: 2 weeks after the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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2 weeks after the first intervention
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Kinematic data of computerized 3D motion analysis
Zeitfenster: 4 weeks after the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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4 weeks after the first intervention
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Kinematic data of computerized 3D motion analysis
Zeitfenster: 4 weeks after the final intervention
|
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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4 weeks after the final intervention
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
18. Juni 2015
Primärer Abschluss (Tatsächlich)
26. Juni 2018
Studienabschluss (Tatsächlich)
26. Juni 2018
Studienanmeldedaten
Zuerst eingereicht
30. Januar 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Februar 2017
Zuerst gepostet (Schätzen)
3. Februar 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. März 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. März 2019
Zuletzt verifiziert
1. März 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1-2014-0083
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