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ArmAssist Robotic Device for Arm Training

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ClinicalTrials.gov Identifier: NCT02729649
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Konstantinovic Ljubica, University of Belgrade

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemiparesis Device: ArmAssist robotic training Other: Conventional therapy Other: Extended conventional therapy Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Fugl Mayer motor score for upper extremity [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Ashworth score [ Time Frame: 4 weeks ]
  2. Action research arm score [ Time Frame: 4 weeks ]
  3. Wolf motor function test [ Time Frame: 4 weeks ]
  4. Barthel index [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729649


Locations
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Serbia
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Konstantinovic Ljubica, professor, University of Belgrade
ClinicalTrials.gov Identifier: NCT02729649    
Other Study ID Numbers: LK-3
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Paresis
Neurologic Manifestations
Nervous System Diseases