Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients
14 maart 2019 bijgewerkt door: 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
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
108
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Seoul, Korea, republiek van, 03722
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Fugl-Meyer Assessment (FMA)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Wolf motor function test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
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4 weeks after the first intervention
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Wolf motor function test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
18 juni 2015
Primaire voltooiing (Werkelijk)
26 juni 2018
Studie voltooiing (Werkelijk)
26 juni 2018
Studieregistratiedata
Eerst ingediend
30 januari 2017
Eerst ingediend dat voldeed aan de QC-criteria
1 februari 2017
Eerst geplaatst (Schatting)
3 februari 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 maart 2019
Laatste update ingediend die voldeed aan QC-criteria
14 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1-2014-0083
Plan Individuele Deelnemersgegevens (IPD)
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