- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03750526
Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
9 december 2019 bijgewerkt door: Lai chien hung, Taipei Medical University Hospital
Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke.
Forty participants will be recruited in this study.
They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study.
All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program.
Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before and after intervention in all participants.
Studietype
Ingrijpend
Inschrijving (Verwacht)
40
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
-
-
-
Taipei, Taiwan
- Werving
- Taipei Medical University Hospital
-
-
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 tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
- Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
- Participants are stable in medical and psychological condition.
Exclusion Criteria:
- Participants have other neurologic problems that can affect balance and walking ability.
- Participants take of drugs or have other medical condition that can affect balance and function.
- Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
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: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: rTMS and AR group
Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
|
rTMS performs 1Hz,15 minutes real rTMS.
AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
|
Actieve vergelijker: Sham rTMS and AR group
Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
|
Sham rTMS applies 1Hz, 15 minutes sham rTMS.
AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
|
Actieve vergelijker: AR group
Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
|
AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
|
Actieve vergelijker: Conventional physiotherapy group
Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
|
Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change of Time Up Go test (TUG)
Tijdsspanne: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
The TUG test will ask participants to stand up, walk for 3 m, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
|
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change of Berg Balance Scale (BBS)
Tijdsspanne: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance.
Each task was scored on a 5-point ordinal scale (from 0 to 4).
A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion.
The highest possible score is 56.
|
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Change of Motor evoked potential (MEP)
Tijdsspanne: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex.
All TMS is delivered with the participant seated upright on the chair.
Both passive and active conditions, participants are instructed to relax their right leg in the seated position.
TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom).
To locate the optimal site, stimuli are delivered over various points along the M1.
The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles.
The onset latency and onset to peak amplitude will be assessed.
|
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Tijdsspanne: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control.
Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance).
The total score range from 0 (no motor function) to 34 (good motor recovery).
|
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Change of Multi-directional Reach Test (MDRT)
Tijdsspanne: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Participants will be required to reach in the forward, left and right directions.
The test is performed with the participant in standing.
It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support.
The test uses a centimeters measuring device against a wall at shoulder height.
|
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Change of The Postural Assessment Scale for Stroke Patients (PASS)
Tijdsspanne: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke.
It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture.
The PASS consists of 2 sections with a 4-point scale to describe each task.
The total score ranges from 0 - 36.
A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion.
The highest possible score is 36.
|
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Change of Taiwanese Depression Questionnaires (TDQ)
Tijdsspanne: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week.
The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity.
Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week".
Zero denotes never, three means always.
TDQ scores range from 0 to 54.
|
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
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)
31 juli 2018
Primaire voltooiing (Verwacht)
30 oktober 2020
Studie voltooiing (Verwacht)
30 december 2020
Studieregistratiedata
Eerst ingediend
20 november 2018
Eerst ingediend dat voldeed aan de QC-criteria
20 november 2018
Eerst geplaatst (Werkelijk)
23 november 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 december 2019
Laatste update ingediend die voldeed aan QC-criteria
9 december 2019
Laatst geverifieerd
1 december 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- N201703084
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op rTMS and AR
-
Aerie PharmaceuticalsVoltooidDiabetisch macula-oedeem | Neovasculaire leeftijdsgebonden maculaire degeneratieVerenigde Staten
-
ALTality, Inc.National Institute on Drug Abuse (NIDA); M.D. Anderson Cancer Center; Baylor College...Actief, niet wervendChirurgie | KinderkankerVerenigde Staten
-
Massachusetts General HospitalAmerican Psychological Foundation; The Hilda & Preston Davis FoundationVoltooidVermijdende/restrictieve voedselinnamestoornis (ARFID)Verenigde Staten
-
San Diego State UniversityNational Institute of Mental Health (NIMH)VoltooidGegeneraliseerde angststoornisVerenigde Staten
-
Chang Gung UniversityWervingZiekte van Parkinson (PD)Taiwan
-
Aerie PharmaceuticalsVoltooid
-
Stanford UniversityVoltooidPijn, acuut | Pijn, neuropathischVerenigde Staten
-
Aerie PharmaceuticalsVoltooidOculaire hypertensie | OpenhoekglaucoomVerenigde Staten
-
Aridis Pharmaceuticals, Inc.VoltooidStaphylococcus aureus | Longontsteking, ventilator-geassocieerd | Infectie, bacterieel | Long infectieWit-Rusland, België, Brazilië, China, Estland, Frankrijk, Georgië, Israël, Letland, Mexico, Russische Federatie, Zuid-Afrika, Spanje, Kalkoen, Oekraïne