ArmAssist Robotic Device for Arm Training

Not Applicable

Completed

• Conditions: Hemiparesis
• Interventions: Other: Conventional therapy; Device: ArmAssist robotic training; Other: Extended conventional therapy

• Registration Number: NCT02729649
• Lead Sponsor: University of Belgrade

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-06
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended Conventional therapy	Conventional therapy	The group will be treated with extended conventional therapy.
ArmAssist therapy	Conventional therapy	The group will be treated with ArmAssist robot therapy.
Extended Conventional therapy	Extended conventional therapy	The group will be treated with extended conventional therapy.
ArmAssist therapy	ArmAssist robotic training	The group will be treated with ArmAssist robot therapy.
Conventional therapy	Conventional therapy	The group will be treated with conventional therapy.

Primary Outcome Measures

Name	Time	Method
Fugl Mayer motor score for upper extremity	4 weeks

Secondary Outcome Measures

Name	Time	Method
Action research arm score	4 weeks
Ashworth score	4 weeks
Wolf motor function test	4 weeks
Barthel index	4 weeks

Trial Locations

Locations (1)

Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade; 🇷🇸 Belgrade, Serbia