Status:
UNKNOWN
Assessment of a Upper Limb Robotic Device in Stroke Patients
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Stroke
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
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 rehabili...
Eligibility Criteria
Inclusion
- Inlcusion Criteria:
- Between 40 and 65 years.
- Both genders.
- Clinical and radiological diagnosis of ischemic stroke in the vascular territory of the middle cerebral artery or anterior cerebral artery.
- Clinical assessment of disability with diagnosis of right or left hemiparesis.
- Onset between 24 and 36 months.
- Clinical stability verified in medical evaluation.
- Spasticity less than or equal to 2 in Modified Ashworth Scale.
- Moderate motor impairment in upper limb, according to Fugl-Meyer Assessment Upper Limb score (34 to 55 points).
- To remain seated in a backrest chair during the intervention period (about 55 minutes).
- Acceptance of informed consent form to participate in the study.
- Exclusion Criteria:
- Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.
- Progressive worsening of spasticity.
- Withdrawal of the informed consent form.
- New episode of stroke.
- Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.
Exclusion
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03469778
Start Date
May 2 2018
End Date
September 1 2018
Last Update
March 19 2018
Active Locations (1)
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1
Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação
São Paulo, Brazil, 04116-040