ArmeoSenso - Reward

NCT ID: NCT02257125

Last Updated: 2020-08-13

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

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-27

Study Completion Date

2019-10-28

Brief Summary

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This study investigates the use of motivating/rewarding features in a computer based arm rehabilitation program. Half of the subjects will take part, besides receiving standard therapy, in a computer based program delivering a game like scenario with visual effects and monetary rewards in case of successful level completion, while the other half will take part in a similar program without visual effects or the possibility to earn money.

Detailed Description

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Rewards not only increase motivation to train, but have also been shown to influence motor skill learning via activation of dopaminergic brain structures. In goal oriented tasks, receiving information about goal achievement has a rewarding value, which is further increased if performance has monetary consequences. Computer games often strengthen this kind of information by presenting explosions and other salient stimuli when a goal is achieved (e.g. a target has been reached). The current study investigates the outcome of an arm rehabilitation program, based on such a computer game delivered in two versions. Stroke patients are asked to use their impaired arms to perform goal oriented movements. Movements are translated into movements of a virtual arm on a computer screen. Goals are "meteors", threatening to destroy a planet on which they fall, if not caught by the virtual arm. One version of the computer game delivers state of the art graphics including a number of visual effects and, if the planet was protected successfully, information about a monetary reward, whereas the other version of the program delivers schematic graphic objects only. Training time and intensity are kept constant and outcome measures, including standard clinical motor assessments, are compared between the groups.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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high incentive

game version including visual effects and monetary rewards

Group Type EXPERIMENTAL

high incentive

Intervention Type BEHAVIORAL

Subjects are required to use their arms in order to control a virtual arm on a computer screen to prevent meteors from destroying a planet. The game includes visual effects and monetary rewards.

low incentive

game version without visual effects or monetary rewards

Group Type ACTIVE_COMPARATOR

low incentive

Intervention Type BEHAVIORAL

Subjects are required to use their arms in order to control a virtual "hand" on a computer screen to prevent objects from reaching the bottom. The game does not include visual effects or monetary rewards.

Interventions

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high incentive

Subjects are required to use their arms in order to control a virtual arm on a computer screen to prevent meteors from destroying a planet. The game includes visual effects and monetary rewards.

Intervention Type BEHAVIORAL

low incentive

Subjects are required to use their arms in order to control a virtual "hand" on a computer screen to prevent objects from reaching the bottom. The game does not include visual effects or monetary rewards.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* stroke survivor (max. 100 days post-stroke)
* upper extremity motor deficits
* patient can lift the paretic arm against gravity
* patient can move the hand at least 20x20 cm in a horizontal plane
* patient is able and willing to participate
* patient has signed informed consent

Exclusion Criteria

* severe aphasia (impairing verbal instructions)
* severe dementia (impairing the capability to understand instructions)
* severe depression (impairing motivation to train)
* relevant (in the judgement of the investigator) impairment of visual perception, (impairing perception of goals and feedback on the computer screen)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Cereneo AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Luft, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, University Hospital Zurich

Locations

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Cereneo, Center For Rehabilitation and Neurology

Vitznau, Canton of Lucerne, Switzerland

Site Status

Klinik Adelheid

Unterägeri, Canton of Zug, Switzerland

Site Status

Zuercher Reha Zentrum Wald

Wald, , Switzerland

Site Status

Countries

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Switzerland

References

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Widmer M, Held JPO, Wittmann F, Valladares B, Lambercy O, Sturzenegger C, Palla A, Lutz K, Luft AR. Reward During Arm Training Improves Impairment and Activity After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Feb;36(2):140-150. doi: 10.1177/15459683211062898. Epub 2021 Dec 22.

Reference Type DERIVED
PMID: 34937456 (View on PubMed)

Widmer M, Held JP, Wittmann F, Lambercy O, Lutz K, Luft AR. Does motivation matter in upper-limb rehabilitation after stroke? ArmeoSenso-Reward: study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):580. doi: 10.1186/s13063-017-2328-2.

Reference Type DERIVED
PMID: 29197412 (View on PubMed)

Other Identifiers

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EKNZ (LU) 13079

Identifier Type: -

Identifier Source: org_study_id

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