Stroke Clinical Trial
— ROTSOfficial title:
Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
NCT number | NCT02416791 |
Other study ID # | 513.207 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | December 2016 |
Verified date | December 2015 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.
Status | Terminated |
Enrollment | 9 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Conselho Nacional de Desenvolvimento Científico e Tecnológico |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Upper Extremity Fugl Meyer Assessment | Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity. | 6 weeks from baseline | |
Primary | Percentage of Sessions With Adverse Events | Post treatment (6 weeks from baseline). | ||
Secondary | Change in Modified Rankin Scale | Scores range from 0 to 6. Higher scores indicate greater severity. | 6 weeks from baseline | |
Secondary | Change in National Institutes of Health Stroke Scale | Scores range from 0 to 42. Higher scores indicate greater severity. | 6 weeks from baseline | |
Secondary | Change in Stroke Impact Scale | 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. | 6 weeks from baseline | |
Secondary | Number of Participants Who Presented Score on Modified Ashworth Scale >2 | Scores range from 0 to 4, with 5 choices. A score of 1 indicates no resistance, and 4 indicates rigidity. | 6 weeks | |
Secondary | Change in Motor Activity Log | Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity. | 6 weeks from baseline | |
Secondary | Upper Extremity Fugl Meyer Assessment | Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity. | 6 months follow-up | |
Secondary | Number of Participants With Adverse Events | 6 months follow-up | ||
Secondary | Change in Fatigue Severity Scale | 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 | |
Secondary | Change in Pittsburgh Sleep Quality Index | 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. | 6 weeks from baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Enrolling by invitation |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Active, not recruiting |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |