Skip to content

ArmeoSenso - Reward

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02257125
Enrollment
38
Registered
2014-10-06
Start date
2015-01-27
Completion date
2019-10-28
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

rehabilitation, virtual reality, stroke, upper extremity, arm, feedback, reward

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.

Interventions

BEHAVIORALhigh 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.

BEHAVIORALlow 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.

Sponsors

University of Zurich
CollaboratorOTHER
Cereneo AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in ArmeoSenso - hand workspaceAssessed 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.

Secondary

MeasureTime frameDescription
Wolf Motor Function TestBaseline (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.
Fugl-Meyer Assessment Upper ExtremityBaseline (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.
Box and Blocks TestBaseline (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.
Motivation questionnaireAssessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)Measures motivation to train.
Motor Activity Log 14 (MAL-14)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.
Barthel IndexBaseline (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.
NIHSSBaseline (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.
ArmeoSenso: pointing taskAssessed 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026