Assessment of a Upper Limb Robotic Device in Stroke Patients

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Stroke

Treatments: Device: Robotic Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03469778

71611217.5.0000.0068

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inlcusion Criteria:

1. Between 40 and 65 years.
2. Both genders.
3. Clinical and radiological diagnosis of ischemic stroke in the vascular territory of the middle cerebral artery or anterior cerebral artery.
4. Clinical assessment of disability with diagnosis of right or left hemiparesis.
5. Onset between 24 and 36 months.
6. Clinical stability verified in medical evaluation.
7. Spasticity less than or equal to 2 in Modified Ashworth Scale.
8. Moderate motor impairment in upper limb, according to Fugl-Meyer Assessment Upper Limb score (34 to 55 points).
9. To remain seated in a backrest chair during the intervention period (about 55 minutes).
10. Acceptance of informed consent form to participate in the study.

Exclusion Criteria:

1. Joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks.
2. Progressive worsening of spasticity.
3. Withdrawal of the informed consent form.
4. New episode of stroke.
5. Comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Robotic Therapy

Experimental group

Description:

After consent, 10 participants will be included in a training program, as described below: 1º session will be robotic calibration and assessment; the following 18 sessions will be conducted the robotic therapy for upper limbs, three times a week. Each session will have a total duration of 55 minutes, including initial patient positioning and adjusting and after a sequence of game tasks.

Treatment:

Device: Robotic Therapy