Assessment of a Upper Limb Robotic Device in Stroke Patients

NCT ID: NCT03469778

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2018-09-30

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 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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Robotic Therapy

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.

Group Type: EXPERIMENTAL

Robotic Therapy

Intervention Type: DEVICE

Robotic Therapy

Interventions

Robotic Therapy

Robotic Therapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Pesquisa Clínica - Instituto de Medicina Física e Reabilitação

São Paulo, , Brazil

Countries

Brazil

Facility Contacts

Thais Tavares Terranova

Role: primary

thais.terranova@gmail.com

5180-7800 ext. 7897

Artur César Aquino dos Santos

Role: backup

artur.santos@hc.fm.usp.br

5180-7800 ext. 7897

Other Identifiers

71611217.5.0000.0068

Identifier Type: -

Identifier Source: org_study_id