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ArmAssist Robotic Device for Arm Training

Primary Purpose

Hemiparesis

Status
Completed
Phase
Phase 1
Locations
Serbia
Study Type
Interventional
Intervention
ArmAssist robotic training
Conventional therapy
Extended conventional therapy
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiparesis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

ArmAssist therapy

Conventional therapy

Extended Conventional therapy

Arm Description

The group will be treated with ArmAssist robot therapy.

The group will be treated with conventional therapy.

The group will be treated with extended conventional therapy.

Outcomes

Primary Outcome Measures

Fugl Mayer motor score for upper extremity

Secondary Outcome Measures

Ashworth score
Action research arm score
Wolf motor function test
Barthel index

Full Information

First Posted
March 29, 2016
Last Updated
April 25, 2017
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT02729649
Brief Title
ArmAssist Robotic Device for Arm Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ArmAssist therapy
Arm Type
Experimental
Arm Description
The group will be treated with ArmAssist robot therapy.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
The group will be treated with conventional therapy.
Arm Title
Extended Conventional therapy
Arm Type
Active Comparator
Arm Description
The group will be treated with extended conventional therapy.
Intervention Type
Device
Intervention Name(s)
ArmAssist robotic training
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Type
Other
Intervention Name(s)
Extended conventional therapy
Primary Outcome Measure Information:
Title
Fugl Mayer motor score for upper extremity
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Ashworth score
Time Frame
4 weeks
Title
Action research arm score
Time Frame
4 weeks
Title
Wolf motor function test
Time Frame
4 weeks
Title
Barthel index
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
28251157
Citation
Tomic TJ, Savic AM, Vidakovic AS, Rodic SZ, Isakovic MS, Rodriguez-de-Pablo C, Keller T, Konstantinovic LM. ArmAssist Robotic System versus Matched Conventional Therapy for Poststroke Upper Limb Rehabilitation: A Randomized Clinical Trial. Biomed Res Int. 2017;2017:7659893. doi: 10.1155/2017/7659893. Epub 2017 Jan 31.
Results Reference
derived

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ArmAssist Robotic Device for Arm Training

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