Effect of GPR on rehabilitation and sleep after stroke

Phase 1

• Conditions: Physiotherapy; H02.010.625

• Registration Number: RBR-9tvfk2
• Lead Sponsor: Fundação de Amparo à Pesquisa do estado de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes, with age greater than or equal to 18 years of age; Patients with Apnea and Hypopnea Index ? 15; Patients with a history suggestive of a first acute stroke will be invited or may apply to participate in the study; Subacute stage of stroke (between 30 days and 3 months after disease onset); Magnetic Nuclear Resonance or Computed Tomography of the brain performed after hospital admission demonstrating ischemic or hemorrhagic stroke; Patients with NIHSS scores for stroke between 5 and 20 (moderate to moderate / severe stroke-motor impairment) at the time of entry study evaluation; Availability of attendance at physical therapy and assessment sessions; Accept in participating in the study and signing the Informed Consent Term (TCLE).

Exclusion Criteria

Patients with other associated neurological or sleep disorders that interfere with rehabilitation;Patients with renal insufficiency; Previous presence of stroke, subarachnoid hemorrhage or due to secondary cause, malformation, vasculitis, brain tumor or head trauma; Use of potent sedative drugs or continuous sedation; Patients with associated restrictive pulmonary or peripheral vascular diseases; Patients with congestive heart failure or class III or IV heart failure of the New York Heart Association Functional Classification; Non-cooperative patients due to lowering of level of consciousness, impairment of language, vision or important cognitive (verified by Montreal Cognitive Assessment (MoCA, Simões et al, 2008); Previous sleep breathing disorders under treatment; Patients who miss physical therapy sessions without replacement.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the effect of physiotherapy on posture.;Avaliar o efeito da fisioterapia qualidade de sono por meio de questionários: Escala de sonolência de Epworth (corte = 9) e ÍOndice de qualidade de sono de Pitsburgh (<5=boa qualidade de sono, .ou igual 5 e <10=má qualdiade de sono, e >10= indica disturbio de sono, antes e após 16 semanas de tratamento.;To evaluate the effect of physical therapy on the sleep pattern by means of an all-night polysomnography examination, according to the American Academy of Sleep Medicine criteria.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of sedestation / immobilism and standing / activity on the AHI and on the redistribution of fluids, measured by means of the Segmental Electric Bioimpedance Test.