ArmeoSenso - Reward

August 11, 2020 updated by: Cereneo AG

ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Wald, Switzerland
        • Zuercher Reha Zentrum Wald
    • Lucerne
      • Vitznau, Lucerne, Switzerland, 6354
        • Cereneo, Center For Rehabilitation and Neurology
    • Zug
      • Unterägeri, Zug, Switzerland, 6314
        • Klinik Adelheid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high incentive
game version including visual effects and monetary rewards
Behavioral: 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.
Active Comparator: low incentive
game version without visual effects or monetary rewards
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ArmeoSenso - hand workspace
Time Frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.
The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.
Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation questionnaire
Time Frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Measures motivation to train.
Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Wolf Motor Function Test
Time Frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Quantifies upper extremity motor ability through timed and functional tasks.
Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Fugl-Meyer Assessment Upper Extremity
Time Frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Measures motor impairment.
Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Box and Blocks Test
Time Frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Measures gross manual dexterity.
Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
ArmeoSenso: pointing task
Time Frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Goal is to reach targets in the transversal plane in front of the subject: number of targets and time.
Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Motor Activity Log 14 (MAL-14)
Time Frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Self-reported movement ability.
Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Barthel Index
Time Frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Measure of independence in daily living.
Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
NIHSS
Time Frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Measure of stroke severity.
Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cereneo AG

Collaborators

University of Zurich

Investigators

  • Principal Investigator: Andreas Luft, Prof., University of Zurich, University Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2015

Primary Completion (Actual)

October 28, 2019

Study Completion (Actual)

October 28, 2019

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ (LU) 13079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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