NCT02729649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

March 29, 2016

Last Update Submit

November 27, 2023

Conditions

Hemiparesis

Outcome Measures

Primary Outcomes (1)

  • Fugl Mayer motor score for upper extremity

    4 weeks

Secondary Outcomes (4)

  • Ashworth score

    4 weeks

  • Action research arm score

    4 weeks

  • Wolf motor function test

    4 weeks

  • Barthel index

    4 weeks

Study Arms (3)

ArmAssist therapy

EXPERIMENTAL

The group will be treated with ArmAssist robot therapy.

Device: ArmAssist robotic trainingOther: Conventional therapy

Conventional therapy

ACTIVE COMPARATOR

The group will be treated with conventional therapy.

Other: Conventional therapy

Extended Conventional therapy

ACTIVE COMPARATOR

The group will be treated with extended conventional therapy.

Other: Conventional therapyOther: Extended conventional therapy

Interventions

ArmAssist robotic trainingDEVICE
ArmAssist therapy
Conventional therapyOTHER
ArmAssist therapyConventional therapyExtended Conventional therapy
Extended conventional therapyOTHER
Extended Conventional therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Belgrade, 11000, Serbia

Location

Related Publications (1)

  • 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.

    PMID: 28251157DERIVED

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 6, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

SE(1)