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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Robotic Therapy
Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação
São Paulo, Brazil
Fugl Meyer Assessment Upper Limb (FMA-UL)
FMA-UL evaluates the recovery of the hemiplegic patient after stroke. It includes the measurement of reflex activity, movement with and without synergy, voluntary movements and coordination of shoulder, elbow, wrist, hand.
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Wolf Motor Function Test (WMFT)
WMFT evaluates time performance and functional ability in 17 unimanual tasks.
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Dynamometry - Grasp and Pinch
Instrument to measure palmar and lateral grip (strength in kgf).
Time frame: Mean change from baseline at six weeks (19 sessions of robotic therapy).
Patients safety
Adverse effects questionnaire applied in each session.
Time frame: Adverse effects reported during 6 weeks treatment.
Treatment adherence
Number of patients withdrawing from treatment without justification (drop outs).
Time frame: Drop outs reported during 6 weeks treatment.
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