ArmAssist Robotic Device for Arm Training

Hemiparesis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729649
• Other study ID #: LK-3
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: November 2023
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis
• Paresis

Intervention

Device:
• ArmAssist robotic training

Other:
• Conventional therapy

• Extended conventional therapy

Locations

Country	Name	City	State
Serbia	Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Mayer motor score for upper extremity		4 weeks
Secondary	Ashworth score		4 weeks
Secondary	Action research arm score		4 weeks
Secondary	Wolf motor function test		4 weeks
Secondary	Barthel index		4 weeks