Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke (ROTS)
Přehled studie
Postavení
Podmínky
Detailní popis
Our main goal is to confirm the safety of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy, and to conventional therapy alone, for upper limb rehabilitation in an early phase (3-9 weeks) after stroke. Patients will be randomized to receive one of these three treatments, 3 times per week, for 6 weeks.
Data about eventual adverse effect will be collected in each session of treatment. The working hypothesis is that robotic therapy associated with active tDCS and conventional therapy will be as safe as robotic therapy associated with conventional therapy, and as conventional therapy alone.
We will aso preliminarily evaluate the efficacy of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy alone, in improvement of upper limb motor impairment.
Our secondary goals are: 1) To evaluate safety and upper limb motor impairments in patients submitted to each of the three interventions, 6 months after end of treatment; 2) To compare effects of the abovementioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke, immediately after treatment and 6 months later.
The working hypothesis is that the association of robotic therapy, tDCS and conventional therapy will lead to better outcomes than robotic therapy and conventional therapy, or conventional therapy alone.
Patients will be assessed before the first session and after the last session of treatment, as well as 6 months after the last session of treatment.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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SP
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São Paulo, SP, Brazílie, 05403900
- Hospital das Clinicas
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging.
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke.
- Ability to provide written informed consent (patient ou legal representative)
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion Criteria:
- Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 on the Modified Ashworth Spasticity Scale.
- Upper limb plegia
- Uncontrolled medical problems such as end-stage cancer or renal disease
- Pregnancy
- Seizures, except for a single seizure during the first week post stroke
- Pacemakers
- Other neurological disorders such as Parkinson's disease
- Psychiatric illness including severe depression
- Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
- Hemineglect
- Drugs that interfere on cortical excitability, except for antidepressants
- Cerebellar lesions
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Active tDCS + robotic therapy + physical therapy
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
Robotická terapie (MIT - Manus, Interactive Motion Technologies) bude aplikována po dobu 40 minut na paretickou horní končetinu.
Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 40 minutes.
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Aktivní komparátor: sham tDCS + robotic therapy + physical therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
Robotická terapie (MIT - Manus, Interactive Motion Technologies) bude aplikována po dobu 40 minut na paretickou horní končetinu.
Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
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Experimentální: sham tDCS + physical therapy + occupational therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
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Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
Occupational therapy will be administered for 40 minutes.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Upper Extremity Fugl Meyer Assessment
Časové okno: 6 weeks from baseline
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Change in Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 weeks from baseline
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Percentage of Sessions With Adverse Events
Časové okno: Post treatment (6 weeks from baseline).
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Post treatment (6 weeks from baseline).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Modified Rankin Scale
Časové okno: 6 weeks from baseline
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Scores range from 0 to 6. Higher scores indicate greater severity.
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6 weeks from baseline
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Change in National Institutes of Health Stroke Scale
Časové okno: 6 weeks from baseline
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Scores range from 0 to 42.
Higher scores indicate greater severity.
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6 weeks from baseline
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Change in Stroke Impact Scale
Časové okno: 6 weeks from baseline
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Scores in each domain of the Stroke Impact Scale range from 0 to 100, with higher scores indicating a better quality of life.
The change was calculated as the value at the later time point minus the value at the earlier time point; so that, positive numbers represent increases and negative numbers represent decreases.
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6 weeks from baseline
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Number of Participants Who Presented Score on Modified Ashworth Scale >2
Časové okno: 6 weeks
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Scores range from 0 to 4, with 5 choices.
A score of 1 indicates no resistance, and 4 indicates rigidity.
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6 weeks
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Change in Motor Activity Log
Časové okno: 6 weeks from baseline
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Each domain contains taks scored on 0 to 5 ordinal scale.
Lower scores indicate greater severity.
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6 weeks from baseline
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Upper Extremity Fugl Meyer Assessment
Časové okno: 6 months follow-up
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Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 months follow-up
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Number of Participants With Adverse Events
Časové okno: 6 months follow-up
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6 months follow-up
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Change in Fatigue Severity Scale
Časové okno: 6 weeks from baseline
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Fatigue Severity Scale is a 9 -item questionnaire. Each item scores on a 7-point scale. The total score range from 9 to 63 points. Higher scores indicate greater fatigue. |
6 weeks from baseline
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Change in Pittsburgh Sleep Quality Index
Časové okno: 6 weeks from baseline
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The global Pittsburgh Sleep Quality Index score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21. Lower scores denote a healthier sleep quality.
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6 weeks from baseline
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Adriana B Conforto, MD Phd, University of Sao Paulo
Publikace a užitečné odkazy
Termíny studijních záznamů
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Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
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Další relevantní podmínky MeSH
Další identifikační čísla studie
- 513.207
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