Status not kept up to date
Assessment of a Upper Limb Robotic Device in Stroke Patients
NCT03469778 · University of Sao Paulo General Hospital · Updated 19 March 2018
- What is being tested
- Robotic Therapy
- For
- Stroke
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 40 years to 65 years. About 10 people. The full rules are on the registry page.
- Where
- Brazil
- When
- Starts or started 2 May 2018, ends Sept 2018. Registered 19 March 2018.
- Results
- None posted yet.
In the researchers' words
The objectives of this phase II clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Universidade de São Paulo - IMREA HCFMUSP - Rede de Reabilitação Lucy Montoro, unidade Vila Mariana). Methods: 10 patients with stroke diagnosis and Fugl-Meyer score ranging from 34 to 55 will be selected to be included in the study. After signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. After this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.
Sites
- Centro de Pesquisa Clínica - Instituto de Medicina Física e ReabilitaçãoSão Paulo, Brazil