ArmAssist Robotic Device for Arm Training

University of Belgrade

Status: Completed

Conditions: Hemiparesis

Treatments: Other: Extended conventional therapy; Device: ArmAssist robotic training; Other: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02729649

LK-3

Details and patient eligibility

About

ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.

Enrollment: 90 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• unilateral paresis;
• ability to understand and follow simple instructions;
• minimum ability to perform active movements, even though trunk compensation, using the shoulder and/or the elbow joints.

Exclusion criteria

• bilateral impairment;
• severe sensory deficits in the paretic upper limb;
• cognitive impairment or behavioral dysfunction that would influence the ability to understand or perform the experiment;
• inability to provide informed consent;
• other current severe medical problems.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

ArmAssist therapy

Experimental group

Description:

The group will be treated with ArmAssist robot therapy.

Treatment:

Other: Conventional therapy

Device: ArmAssist robotic training

Conventional therapy

Active Comparator group

Description:

The group will be treated with conventional therapy.

Treatment:

Other: Conventional therapy

Extended Conventional therapy

Active Comparator group

Description:

The group will be treated with extended conventional therapy.

Treatment:

Other: Conventional therapy

Other: Extended conventional therapy