Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Stroke Patients (PUAA)

Maimónides Biomedical Research Institute of Córdoba

Status: Completed

Conditions: Rehabilitation; Telerehabilitation; Robot-assisted Therapy; Stroke; Upper Limb Rehabilitation

Treatments: Device: ArmAssist

Study type: Interventional

Funder types: Other

Identifiers

NCT04405609

ArmAssist 2.0

Details and patient eligibility

About

The purpose of this study is to validate the usability of ArmAssist medical device, a robotic system for the rehabilitation of upper limbs in stroke patients (based on serious games). This study evaluate the usability of the system in a home environment, taking into account the ease-to-use, consistency and others; and will pretend demonstrate the feasibility of including or no, robotic therapy in home like complement of daily rehabilitation program. Finally this study investigate the acceptance from patients and therapists.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects over 18,
• Upper limb hemiparesis after stroke,
• Unilateral paresis and cognitive ability to understand,
• Accept and actively participate in the usability study.

Exclusion criteria

• Bilateral motor deficit,
• Severe spasticity,
• Psychiatric illness,
• and/or cognitive impairment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

ArmAssist group

Experimental group

Description:

The post-stroke patients who participate in the study, are classified in differents stages (3 patients in each stage). Group 1: subacute, between 2 - 6 months Group 2: chronic of short evolution, between 6 - 12 months Group 3: long-term chronic, more than 12 months. The system is tested in a clinical (training) and patients' home setting. The ArmAssist system includes the ArmAsist 2.0 device (without motors), the tele rehabilitation platform based on serious games and Antari's HomeCare tele-care platform for the clinicians.

Treatment:

Device: ArmAssist