ArmAssist Robotic Device for Arm Training

November 27, 2023 updated by: Konstantinovic Ljubica, University of Belgrade
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ArmAssist therapy
The group will be treated with ArmAssist robot therapy.
Device: ArmAssist robotic training
Other: Conventional therapy
Active Comparator: Conventional therapy
The group will be treated with conventional therapy.
Other: Conventional therapy
Active Comparator: Extended Conventional therapy
The group will be treated with extended conventional therapy.
Other: Conventional therapy
Other: Extended conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl Mayer motor score for upper extremity
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Ashworth score
Time Frame: 4 weeks
4 weeks
Action research arm score
Time Frame: 4 weeks
4 weeks
Wolf motor function test
Time Frame: 4 weeks
4 weeks
Barthel index
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimated)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LK-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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