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ArmeoSenso - Reward

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
high incentive
low incentive
Sponsored by
Cereneo AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation, virtual reality, stroke, upper extremity, arm, feedback, reward

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cereneo, Center For Rehabilitation and Neurology
  • Klinik Adelheid
  • Zuercher Reha Zentrum Wald

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high incentive

low incentive

Arm Description

game version including visual effects and monetary rewards

game version without visual effects or monetary rewards

Outcomes

Primary Outcome Measures

Change in ArmeoSenso - hand workspace
The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.

Secondary Outcome Measures

Motivation questionnaire
Measures motivation to train.
Wolf Motor Function Test
Quantifies upper extremity motor ability through timed and functional tasks.
Fugl-Meyer Assessment Upper Extremity
Measures motor impairment.
Box and Blocks Test
Measures gross manual dexterity.
ArmeoSenso: pointing task
Goal is to reach targets in the transversal plane in front of the subject: number of targets and time.
Motor Activity Log 14 (MAL-14)
Self-reported movement ability.
Barthel Index
Measure of independence in daily living.
NIHSS
Measure of stroke severity.

Full Information

First Posted
September 30, 2014
Last Updated
August 11, 2020
Sponsor
Cereneo AG
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02257125
Brief Title
ArmeoSenso - Reward
Official Title
ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to futility considerations: Sample size calculations have assumed smaller effect sizes than considered relevant now.
Study Start Date
January 27, 2015 (Actual)
Primary Completion Date
October 28, 2019 (Actual)
Study Completion Date
October 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cereneo AG
Collaborators
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rehabilitation, virtual reality, stroke, upper extremity, arm, feedback, reward

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high incentive
Arm Type
Experimental
Arm Description
game version including visual effects and monetary rewards
Arm Title
low incentive
Arm Type
Active Comparator
Arm Description
game version without visual effects or monetary rewards
Intervention Type
Behavioral
Intervention Name(s)
high incentive
Intervention Description
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
Intervention Name(s)
low incentive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in ArmeoSenso - hand workspace
Description
The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.
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.
Secondary Outcome Measure Information:
Title
Motivation questionnaire
Description
Measures motivation to train.
Time Frame
Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Title
Wolf Motor Function Test
Description
Quantifies upper extremity motor ability through timed and functional tasks.
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)
Title
Fugl-Meyer Assessment Upper Extremity
Description
Measures motor impairment.
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)
Title
Box and Blocks Test
Description
Measures gross manual dexterity.
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)
Title
ArmeoSenso: pointing task
Description
Goal is to reach targets in the transversal plane in front of the subject: number of targets and time.
Time Frame
Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Title
Motor Activity Log 14 (MAL-14)
Description
Self-reported movement ability.
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)
Title
Barthel Index
Description
Measure of independence in daily living.
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)
Title
NIHSS
Description
Measure of stroke severity.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Luft, Prof.
Organizational Affiliation
University of Zurich, University Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cereneo, Center For Rehabilitation and Neurology
City
Vitznau
State/Province
Lucerne
ZIP/Postal Code
6354
Country
Switzerland
Facility Name
Klinik Adelheid
City
Unterägeri
State/Province
Zug
ZIP/Postal Code
6314
Country
Switzerland
Facility Name
Zuercher Reha Zentrum Wald
City
Wald
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34937456
Citation
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.
Results Reference
derived
PubMed Identifier
29197412
Citation
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.
Results Reference
derived

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ArmeoSenso - Reward

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