ArmAssist Robotic Device for Arm Training

NCT ID: NCT02729649

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ArmAssist therapy

The group will be treated with ArmAssist robot therapy.

Group Type EXPERIMENTAL

ArmAssist robotic training

Intervention Type DEVICE

Conventional therapy

Intervention Type OTHER

Conventional therapy

The group will be treated with conventional therapy.

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

Extended Conventional therapy

The group will be treated with extended conventional therapy.

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

Extended conventional therapy

Intervention Type OTHER

Interventions

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ArmAssist robotic training

Intervention Type DEVICE

Conventional therapy

Intervention Type OTHER

Extended conventional therapy

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

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Konstantinovic Ljubica

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Belgrade, , Serbia

Site Status

Countries

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Serbia

References

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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.

Reference Type DERIVED
PMID: 28251157 (View on PubMed)

Other Identifiers

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LK-3

Identifier Type: -

Identifier Source: org_study_id